Policy > General > Piperazines

Transform Drug Policy Foundation Briefing (Oct 2006):

Piperazines – how to regulate an emerging recreational drug not covered by existing legislation.

Introduction
Current situation in the UK
The New Zealand experience
Discussion
Recommendations
Appendices and further reading

Introduction / Summary

A new ‘family' of drugs, the piperazines (including a number of different yet chemically similar drugs with a range of effects – see appendix ), has emerged on the recreational drugs market over the past couple of years. Some are licensed medicines but others currently have an ambiguous legal status in the UK, with some possibly covered by the Medicines Act 1968 and others awaiting decisions on their classification under the Act by the MRHA (the Medical and Healthcare Products Regulatory Agency). None are currently covered under the Misuse of Drugs Act 1971

The ‘legal highs' market has taken advantage of this legal ambiguity and various Piperazines products and preparations are now available online or in ‘head shops' across the UK – usually sold under the brand name of ‘p.e.p pills'. This raises important questions about how such substances should be produced and sold and under what legislation such activity should be regulated. There have been some interesting developments regarding this group of drugs in New Zealand, which has established a new drug classification, a ‘Class D', which enables certain drugs on a ‘restricted list' to be sold under various licensing conditions. Shortcomings of this new licensing system are related to inadequate enforcement. Clearly enforcement is a key issue for any regulatory model, including those already in place in the UK, notably alcohol, as has been highlighted in the recent ACMD report: ‘Pathways to Problems' [1].

This briefing provides a summary of current knowledge on recreational piperazines (unfortunately quite limited), the current situation in the UK and the experience in New Zealand, before discussion and recommendations on pragmatic ways forward.

Transform is in no way advocating on behalf of the ‘legal high' industry, merely calling for effective regulation of existing and potential future markets for recreational drugs. Accepting that the current system of voluntary regulation is inadequate the clear choice is between appropriate legal regulation, or prohibition leading to illegal deregulation. Transform suggest that the New Zealand regulatory model involving a new ‘Class D' provides a sensible way forward for recreational piperazines and potentially for other drugs in the future, allowing for appropriate regulation based on harm assessments to be put in place under the direction of the ACMD.

The current UK situation

Piperazines are relatively new on the UK recreational drugs scene, but have become increasingly popular as stimulants in the past two years. They are sold in ‘head shops', from online suppliers, at festival and club ‘legal high' stalls, most commonly under the brand ‘p.e.p pills'. The main suppliers, Spiritual Highs ^[2], offers four products, two containing just BZP – in two strengths – and two containing BZP and TFMPP combined – again in two strengths ( see appendix for details on these substances ).

The increasing use of these drugs has mostly been through word of mouth, but also thanks to coverage in some dance music and underground media – for example in Mixmag which recently reported on the new ‘legal ecstasy' . Whilst p.e.p pills are not regarded as highly as ecstasy amongst the party scene, the fact they are relatively inexpensive, legal, and are of known strength and purity (although such quality control is not legislated) means that they present a number of advantages over the illicit options, often random ‘pills' or powders sold as ecstasy/MDMA/speed by strangers in nightclubs or from unregulated street markets.

Many products in the world of ‘legal highs' have limited, or no effects and consequently have limited appeal. P.e.p pills by contrast clearly do work, hence the growing market. The main UK supplier, Spiritual Highs, have told Transform that they have, until very recently, been shipping up to 3600 doses a day, online and to over a hundred outlets in the UK.

Currently, we are informed that shipping is suspended pending a ruling from the MRHA on the legal status of BZP and TFMPP. There appears to be some confusion over which of the piperazines are covered under the Medicines Act and which are not, not least because the term ‘piperazine' is a term used to describe the family of drugs (Piperazines) as well as an individual drug within this group, one which is covered by the Medicines Act. There is clearly a need for these technical issues to be clarified.

Even if all the active substances in the ‘p.e.p pills' are found to be covered under the Medicines Act this may not dramatically change the nature of the market or supply. It is legal to import drugs covered under the Medicines Act for personal use, so the suppliers would only need to move offshore to continue supplying online, as has happened with other drugs in the past. This would of course make the market considerably more difficult to regulate.

There is clearly a need for a coherent policy and legislative response to this emerging market, not least because similar situations are likely to be repeated in the future. The options are explored below. Usefully we have a precedent in New Zealand where use of piperazines is more established and where a coherent policy response that restricts and licenses sales (rather than opting for an outright prohibition) has already been devised and implemented. The UK retailers are looking to the New Zealand experience to provide a model for sensible regulation of the market, hopefully avoiding a situation where regulatory models do not get any serious consideration because of the ‘get tough' political climate. To protect their potentially lucrative business the UK retailers appear to be approaching the policy implications of future regulated markets more responsibly than ‘legal high' retailers in the past, and on this occasion they have a road tested regulatory model from NZ to draw upon in their support.

Transform note that:

Piperazines are currently not featured on the Talk to Frank drug information website
There is no reference to them on the Home Office drugs website,
They have not been raised in Parliamentary debates or questions
The company ‘Spiritual Highs' have been marketing their Piperazines products as ‘harm reduction solutions' . Whilst there are likely to be harm reduction benefits from their regulated legal availability ( see appendix ), Transform have made it clear that this is not an appropriate description for the products. They are psychoactive substances (any use of which involves risk to some degree), and should primarily be described as such.

The New Zealand experience

Over the last few years New Zealand has experienced a dramatic increase in methamphetamine use associated with a variety of social, criminal and health problems, familiar to the experience in the US and Canada (but yet to significantly effect the UK). It was during the emergence of methamphetamine, that BZP and similar drugs from the Piperazines family began to be marketed to the dance and clubbing scene as a ‘ harm reduction option' (whether the legal piperazines market had any impact on methamphetamine use is unclear and it seems more likely that if diversion from illicit drug use occurred it was from conventional amphetamines, or ecstasy/MDMA – see also bullet point above ).

When Piperazines first appeared on the market in NZ they did not fall under any existing legislation (they were erroneously being marketed as food supplements), and the market was essentially an unregulated ‘free for all'. Realising that this situation was untenable and that it was likely to lead to the drugs being included within existing drug legislation, a trade body was established between the various producers and retailers called STANZ, the Social Tonics Association of New Zealand ^[3]. They aimed to ‘clean up' the market and prevent the drug being made illegal so that they could protect their business interests and continue trading within an acceptable regulatory framework.

The NZ Government requested a report on the drug and policy options for its control from the Expert Advisory Committee on Drugs (the EACD, The NZ equivalent to the UK's ACMD) which produced its recommendations after consulting with interested parties including STANZ and various enforcement and health agencies. On the basis of this assessment, the decision was made to restrict sales under license but not to prohibit them. The committee concluded that BZP and TFMPP had low harm potential; noting there had been no fatalities linked to the drugs and that they had low potential for dependency ( see safety appendix ). To this end, (following a suggestion by STANZ) because no appropriate legal framework existed at that time to accommodate these requirements, a new category was created and added to existing drugs legislation – a Class D, supported by a ‘restricted list' detailing licensing conditions and penalties, and administered by the EACD. The new system acknowledged risks but deemed them suitably low to permit the restricted sales of the drug. Problems that have emerged with the system have primarily been due to poor enforcement of the new licensing conditions. Details of this new system and how it might be applied to the UK ( in italics ) are given below.

Legal status of Class D or ‘restricted' drugs in New Zealand – and how the model might work in the UK

Under Part 3 of the NZ Misuse of Drugs Amendment Act 2005 the Expert Advisory Committee on Drugs (NZ version of ACMD) is responsible for assessing drugs for risk in relation to their entry or removal from the restricted list, and if a drug should be restricted what restrictions should apply

It is the restricted list rather than the law itself that is the key instrument; it is here, not in the NZ Misuse of Drugs Act, that the restrictions are detailed for each restricted drug. It is designed in this way to make it more flexible and more adaptable to new drugs and new research. However, because it does not take a vote in the NZ House of Commons for a drug to be put onto or removed from the list, the public's involvement is minimal. On the other hand because the Expert Advisory Committee on Drugs needs to be consulted about any revisions the chance of changes for short term political gain is small, and decisions are to some extent free from political interference.

This basic model has much to recommend it due to the fact that the other possible options seem inappropriate (The Misuse of Drugs Act, the Medicines Act, food supplements legislation, or doing nothing) and would therefore seem to be a sensible way forward for the UK, at least in the short to medium term. It would bring recreational use of specific piperazines use within the ACMD's remit without the need for them to be absolutely prohibited under the Misuse of Drugs Act (the only option it currently allows). Maintaining the ACMD's expert role in taking the lead on classification decisions would give the public confidence that the restrictions are being brought forward by a panel of experts, not politicians. The advent of a separate list also allows for this new law to be very flexible and to allow for variations in sanctions for license violations to be based on a clear risk analysis that could potentially change rapidly if and when new research emerged.

The NZ Misuse of Drugs Act sets out the sanctions available for breaking the specified restrictions. It does not set out absolute penalties for each offence, only establishing an upper limit for fines, leaving flexibility in sentencing with judges.

As in the UK, this flexibility would allow for the judge to decide on a case by case basis what the sanctions should be.

There are fines rather than prison terms for breaking these codes of conduct, for example; up to $2,000 for a person selling to a minor and up to $10,000 for an organisation which breaks advertising rules (figures are NZ dollars).

The new law excludes drugs used for veterinary or industrial use and any drugs already covered by existing legislation. This is to make sure that BZP can continue to be used medically (in cattle for example), or for other legitimate purposes.

The restricted list specifies;

Where the drug can be sold (e.g. not near schools)

Age of purchaser controls

In what doses, strengths and quantities it can be sold (based on a risk assessment)

How the product must be packaged

How the product must be stored, and how much can be stored in each location

What information must be given to the customer at the point of sale (including information about possible interactions with other drugs and medication)

To allay some political and media fears that this was a ‘backdoor to cannabis decriminalisation/legalisation' an amendment has been added to make sure that you cannot move a drug from the illegal statutes to the restricted one without a vote in the NZ House of Commons.

Suppliers, manufacturers and importers are bound to a code of conduct that includes guarantees on the product itself (contents, dose etc), keeping of records of checks, and demonstrating that if necessary they can recall the products supplied. Quality control is the key issue for importers and manufacturers; importers have to assess and guarantee that their product matches the product quality specifications laid down for domestic manufacturers.

These kinds of specifications are already in force and familiar for various pain killers and over the counter medications. It is clear they could operate equally effectively for restricted drugs. Inspections of manufacturers, spot checks on imported material and checks on paperwork could be instituted with relative ease.

All sales must be paid for, and there cannot be any promotion, or coupons, games or similar associated with the purchase of the restricted drug. Giving away the drug or involving it in games or promotions is punishable with up to a $5,000 fine for an individual or $10,000 for a company. The law brings into force a new set of civil servants under the Ministry of Health, somewhat similar to Health and Safety Executive (HSE) investigators. These civil servants have some powers under the new law, but are not part of the Police force.

The enforcing authorities have the right to enter a place selling, making, distributing or importing one of the restricted drugs and take pictures, look at documents and the like. However, this right does not extend to homes, for which the authorities would still need a warrant to enter.

This is no different from current law where the HSE, environmental health officials or the Fire Authorities can enter without a warrant if they feel there are breaches of legislation. Both improvement and prohibition notices already used under health and safety legislation could be used under this law, providing a ready-made template for its enforcement.

If someone is convicted twice of an offence under the Act he/she, or others on behalf of, can be banned from selling, making or distributing restricted drugs. Places where two offences have taken place can also be banned from selling, making or distributing restricted drugs.

Like other penalties under the Act it is flexible and allows for individual circumstances to be taken into account. However, it will allow the authorities to stop suppliers, manufacturers and individuals who are breaking the stipulations of the Act on a repeated basis. Additional sanctions could be introduced for repeat offenders.

The restrictions on BZP are now in place, but (disappointingly from Transform' perspective) are being loosely enforced.

Advertising is still largely allowed, billboards, fliers, sponsorships, posters, websites & web ads, etc.

There is no licence or training required before you can sell the product and because of this many shops and off licences are currently selling them

Controls on the dose and quantity of the drug available are not being rigorously enforced, and whilst most suppliers have signed up to the voluntary code, but some have not, selling doses considered too high.

It has been suggested that part of the reason for this enforcement deficit is because there was a gap between when the law came into force and when the ‘restricted list' was finalised, leading to a period of uncertainty and confusion amongst enforcement agencies, that has not been adequately resolved. This is a lesson we can learn from and make sure that the two elements of the legislation which rely so heavily on each other come into force at the same time.

Clearly a regulatory regime can only function properly if it is being enforced appropriately. This may well be an issue in NZ for piperazines just as it is in the UK for alcohol and tobacco. Transform has long argued that failings of alcohol policy are partly due to poor regulation (e.g.allowing irresponsible advertising and promotions to young people) and partly due to poor enforcement (for example of the law preventing serving alcohol to intoxicated customers in licensed premises). These are key issues for any consideration of regulatory models.

Discussion

Piperazines are psychoactive drugs and clearly not without risks. However, the assessments that have been done suggest that the risks are relatively low ( see safety appendix ), arguably on a par with or less than khat, another legal stimulant (in this case plant based) recently considered by the ACMD ^[4]- for which classification under the MDA was not recommended.

Whilst the demographic profile of khat use (largely limited to traditional use amongst the male Somali community) is very different to that of piperazines (mostly used in the party / club / dance music scene) some of the same conclusions apply.

Costs of prohibiting piperazines would include:

Potential for the creation of an illegal market for drugs that have an established market and level of demand
Profits being diverted from legitimate, taxed and legally liable producers/retailers into the hands criminal gangs and unregulated dealers
Increased risks/harm to users from drugs of unknown strength and purity, sold without any health and safety information
Removal of potential harm reduction gains achieved by diverting recreational users away from more dangerous illegal drugs such as amphetamines (including methamphetamine) and MDMA (ecstasy) and its analogues.
Criminalisation of users, mostly young people
An increase in enforcement costs to police, customs, courts, prisons and probation services

Are there potential benefits to prohibiting piperazines?

Benefits of such a move would seem to be primarily political (i.e. demonstrating ‘tough on drugs' credentials).

A deterrent effect from such a prohibition is possible, but doubtful given that there is already an established demand for these drugs, and those deterred would likely substitute back to other illegal equivalents. Such a deterrent effect is poorly supported by evidence. The Science and Technology Select Committee recently concluded that:

“We have found no solid evidence to support the existence of a deterrent effect, despite the fact that it appears to underpin the Government's policy on classification. In view of the importance of drugs policy and the amount spent on enforcing the penalties associated with the classification system, it is highly unsatisfactory that there is so little knowledge about the system's effectiveness.” ^[5]

The Government presented no evidence in their response to contradict this position. Piperazines (primarily BZP) have been prohibited in a number of countries including the US and it would be useful to examine what effects this had on patterns of use, and knock on effects on the use of other drugs. Transform is not aware that any such research has been undertaken.

There would be no prospect of reduced crime and social disorder, since there is none currently associated with the use of piperazines. According to the New Zealand EACD:

“ there is no reported criminal behavior associated with the use of BZP & TFMPP, as they are moderately priced and have a lower dependence potential than illicit amphetamine” (page 6)

Can we leave the market to self regulate?

The third alternative is to leave the market as it is. This is clearly not a long term tenable situation, even if producers of UK products (from New Zealand) and UK retailers put in place a voluntary code of practice. Although current UK retailers seem to be acting more responsibly than in the past (with, for example, magic mushrooms), there is no guarantee this will be the case for all retailers, and experience with unregulated ‘legal high' markets in the past does not inspire confidence. The New Zealand EACD report states that

“Because there are many new substances that could appear on the market in this way, the challenge for public health practitioners and regulators is how to respond to these new substances in a way that promotes the public health while protecting individual rights. They are generally of lower potency and price than of illicit amphetamines and methamphetamine, and they are commercially packaged, labeled with the major ingredients and their strengths. The distributors would argue that this is a responsible approach to a demonstrated demand for the effects given by these substances.

When first distributed, this was an approach that allowed users to exit the illicit market with its inherent risks and the often poor quality drugs. Substitution of illicit with Piperazine is occurring, mostly amongst users who are afraid of the damage to their lives that a conviction would bring and who also wish to normalise the transaction required to purchase their choice of recreational substance. However, being unregulated at this time, they are being promoted within the free market, which has the generation of profit as the driving force. This can as easily lead to market saturation as can the imperatives driving the black market. Unlike either novel foods or new medicines, these products are being marketed without adequate scientific safety assessments because there is no need for the distributor to seek regulatory pre-market approval from a regulatory agency.” (p.8)

What would be the benefits of introducing appropriate regulation of the market and licensing of producers and vendors?

The idea of having a ‘restricted list' separate from, or a ‘Class D' in addition to the main drugs legislation (i.e. the ABC classification system under the MDA 1971) has many advantages over the status quo:

It would create an enforceable legal structure allowing effective state intervention and control of production, supply (availability), promotion and use. This is not possible under the minimally regulated existing market, any existing regulatory options (medicines Act, food supplement regulations), or under the unregulated criminal market that classification under the MDA would inevitably create.
It allows for full risk assessment of each drug as the basis for tailored penalties/restrictions rather than as a part of the blunt and malfunctioning instrument that is the ABC classification system.
This form of legislation is significantly more flexible than current arrangements under the Misuse of Drugs Act and would allow for restrictions to be changed rapidly in light of new research, emerging trends or changing conditions.
It removes virtually all the risks inherent in criminal markets; separating consumers from the wider criminal market (which in the case of Dutch cannabis policy is suggested to have kept down levels of use of more dangerous drugs) and offering harm reduction benefits from the availability of drugs of known content, strength and purity, and supplied with health and safety information
Harm reduction through diversion away from use of more dangerous drugs.
Harm reduction in terms of reducing the risk of young people being branded with the stigma of a criminal record.

The wider debate over classification and prohibition / regulation

Inevitably perhaps, proposals for a ‘restricted list' and or ‘Class D' will be seen by some as a ‘back door to legalisation' of cannabis and perhaps other drugs, a sentiment aired during the policy debate in New Zealand. The NZ legislation passed, however, following an intelligent public and parliamentary debate and engagement with all the relevant parties.

Transform's position on the current prohibition of drugs is well documented. We believe the enforcement led approach has been spectacularly counterproductive – failing to deliver any of its stated policy goals, maximising harms associated with dug use, creating a crisis in the criminal justice system and fuelling crime at all scales, at home and in producer and transit countries. We believe that drug policy should be led by evidence of effectiveness, established harm reduction principles and public health science. This inevitably leads to the conclusion that regulated markets (with different regulatory models depending on the drug) offer better outcomes than absolute prohibitions on all key policy indicators; crime, social nuisance, public health, welfare of young people and value for money expenditure.

We are not alone in this view of prohibition:

“Prohibition doesn't work, as the US found out many years ago.”

John Reid MP Labour (now Home Secretary in charge of drugs policy): Jeremy Vine programme, BBC Radio 2, 11.11.04

…” we can prohibit, regulate or leave it to the market. Prohibition does not work - it drives the activity underground…”

“Only ideological extremists favour a free-for-all where only the laws of the market hold sway. So the third option is regulation - and regulation with as much emphasis on the quality of the debate as the policy outcome. 'Better regulation' has to mean government engaging people in the decisions that affect their lives and doing so in new and better ways”.

Tessa Jowell MP Labour: 'Grown up politics for an adult world' The Guardian 21.11.04

The Piperazine issue offers a real opportunity to do the right thing, not necessarily the politically expedient one. These are drugs that have yet to attract the attention of a media hungry for drug scare stories (although the first murmurings are beginning to be heard in Ireland), so currently there is little political capital to be made from a high profile crackdown. There is some breathing room in which to address this issue before it gets out of hand. Intelligently handled this need not be a political minefield, and sold as a pragmatic public health intervention to better control a potentially risky substance and keep criminals away from the trade, regulatory options need not be perceived as ‘soft' either.

Important lessons can be learnt from the recent UK experience with fresh magic mushrooms. Whilst there has been well founded criticism that class A is not the appropriate classification for magic mushrooms (or psychedelics more generally), the situation with magic mushrooms was considerably different from that which we are facing with piperazines. Fresh magic mushrooms were legal because of anomaly in the law, rather than because they were a new ‘legal high'. Furthermore they were potentially creating a new market and demand for psychedelics that did not already exist, whereas piperazines are entering, and potentially displacing, existing demand for illegal stimulants (amphetamines and ecstasy) on the party scene. The ban on fresh mushroom sales has been effective at closing down the retailers and returning the market to its previous position, with lower levels of use and production returning to informal harvesting and small scale illegal sales of naturally growing UK mushrooms, that are rarely prosecuted. If there has been a knock on effect in terms of users moving to other drugs (legal or otherwise) this is impossible to quantify, however likely. This ‘success' (at least from the Home Office's point of view) is far less likely to occur following a similar move with piperazines, as has been discussed above, and as was concluded by the NZ Expert Advisory Council..

Similarly lessons can be learnt form the different approach taken with khat, which was rather more pragmatically left unclassified following a thoughtful and thorough investigation and report from the ACMD (unlike magic mushrooms where policy alternatives received only the most cursory of consideration).

Piperazines probably lie in a similar risk spectrum to these drugs and if we have a choice between prohibition under the Misuse of Drugs Act (magic mushrooms, ketamine, GHB), and leaving things as they are (khat), surely the option of regulatory models, which have demonstrable advantages over both, must now be seriously considered. This is likely to remain a live issue as new ‘legal' drugs continue to emerge into the recreational market but are not covered by the UN drug conventions (Kratom, Fly-agaric mushrooms, peyote cactus, salvia divinorum and nitrous-oxide all potentially warranting consideration).

The ongoing debate around the ABC drug classification system has been brought into sharp relief by the recent Science and Technology Select Committee report, which concluded there was a poor scientific basis in support of its efficacy as either a public health tool or criminal justice deterrent. Even though the Home Office has now reneged on its promise to have a thorough review of the classification system (despite the fact that this idea was welcomed by everyone in the drugs field including the ACMD, and specifically requested the Science and Technology Select Committee) it is hoped that possibilities for the classification system to include the a ‘Class D' - offering the possibility of licensed sales of some lower risk drugs - will feature prominently in this ongoing discourse.

The recent ACMD report ‘Pathways to Problems' has recommended that alcohol and tobacco be specifically brought within the remit of the ACMD. Such a move will raise many difficult questions about the historical legal anomalies between legally regulated and totally prohibited drugs. There may well exist possibilities for including alcohol and tobacco in a new ‘restricted' category (which in effect they already inhabit, albeit under separate legislation), and also for moving other misclassified (e.g. some psychedelics) or unclassified drugs (e.g. khat) into the new regulatory system. Transform would welcome a debate on these ideas within the ACMD, given that they have now very publicly opened the door for such a discussion.

Transform welcomes the recent shift in approach to the drugs issue, away from heavy handed enforcement towards public health and harm reduction as the guiding principles, and the development of effective regulatory models for some of the less harmful drugs currently in a legal grey area is inevitably going to be an important part of this process. Piperazines, a fairly marginal issue from Transform's perspective, could offer a useful opportunity to experiment with regulation whilst the stakes remain low, rather than leaving the market to self regulate, or opting for another expensive and counterproductive crackdown.

Recommendations

Initiate an official consultation as part of a formal engagement between the relevant Government agencies (including the Home Office, the Department of Health and the Treasury and key stakeholders including drug services, police and enforcement, NGOs, user groups, producers and retailers) to consider the three key choices for going forward regarding policy and legislation on recreational piperazines (status quo, regulation, prohibition). The possibility for a ‘Class D' or ‘restricted list' for lower risk drugs along the lines of the New Zealand model should specifically be included in the consultation.
That the ACMD produce a report that considers the information available on piperazines, clarifies the legal status and knowledge on of the various substances in question, and makes recommendations on ways forward, in line with similar recent reports on cannabis, khat, methamphetamines etc.
The ACMD should be specifically required to consider the models brought into New Zealand law, and make direct contact with colleagues on the New Zealand EACD, to discuss their findings and recommendations.
In the short to medium Transform recommends the establishing in of a new ‘Class D' within the MDA to enable the licensed sale of certain drugs under the direction of the ACMD.

Appendices and further reading

What are Piperazines?

‘Piperazines' is the name for a family of drugs that have similar molecular structure but a range of different effects on humans. The key members of the group that have been used for non-medical recreational purposes (more detail below) are:

BZP (Benzylpiperazine)
TFMPP (3-trifluoromethylphenylpiperazine monohydrochloride)
mCPP (3-CPP; CPP)

Other members of the group have medical uses:

Sildenafil (also know as the brands Viagra, and Afrodil) - prescribed in the treatment of Erectile Dysfunction. It is commonly referred to as a "lifestyle drug".
Cyclizine (also known as Marezine; Marzine; Emoquil) - a piperazine-derivative antihistamine used in the treatment of motion sickness
Meclizine (also known as Dramamine II; Antivert; Bonine; Bonamine) Meclizine is an antiemetic, antivertigo, antihistamine used to treat motion sickness and the symptoms of vestibular system diseases.

BZP (Benzylpiperazine) –

Used in the 70-150mg dose range, effects are similar to amphetamines.
Disliked by users for the long period of inability to sleep after use, which can be last up to 10 hours after the desirable effects have faded. For this reason some users use sedatives or alcohol at the end of the experience (presenting other unknown risks).
BZP, like TFMPP (see below) affects the serotonin receptors, though only in a minor way and this does not seem to result in euphoric or ‘loved up' feelings (associated with MDMA) – it is primarily used for its stimulant effects.
BZP is an illegal drug in many countries including America where it is Schedule 1 (see further reading for an account of this scheduling).

TFMPP –

The active threshold dose of TFMPP is considerably lower than BZP at around 25mg, with and the upper dose (beyond which the effects become unpleasant) of 100mg.
Like BZP, TFMPP does have an effect on the serotonin receptors and users report that the mix of the two drugs is similar to the euphoric high of MDMA, although neither BZP nor TFMPP appear to have this effect when used alone. This has lead scientists to conclude that the two drugs have a yet known synergistic relationship.
The PEP pills currently sold sometimes mix BZP and TFMPP, a combination that has not been extensively studied.

mCPP –

This drug is of the same family but is not commonly sold via the same routes as BZP pills.
It seems to act more directly on the serotonin receptors than either BZP or TFMPP and therefore could potentially have more sought after effects.
In comparison to MDMA, mCPP does appear to be less neurotoxic but it is dose dependant and could cause serious side effects if mixed with other drugs or taken in large quantities. Also mCPP appears to be less of a CNS stimulant, only slightly raising heart rate, blood pressure etc.
mCPP is not recommended for use by STANZ because of it can produce migraines and is not sold in NZ for this reason.

Safety

There have not been extensive safety trials or risk studies for these drugs amongst recreational users, so conclusions have to be inferred from what information we do have. A review was undertaken in New Zealand in 2004 by the Expert Advisory Committee on Drugs, (EACD, an equivalent body to the UK's ACMD), reporting to the Minister of Health and provides the clearest available picture of the drugs risks. An earlier report on piperazines by the DEA, used to push for there scheduling, appears less independent (and contained errors – see below). The EACD report is available online in pdf format here: http://www.erowid.org/chemicals/bzp/bzp_law2.pdf
At one end of the scale the risk of death seems negligible, with no recorded deaths. The Piperazine retailing association in New Zealand (STANZ) claim their members have sold an estimated 8 million ‘servings' of BZP and related products in the past 5 years ‘with no credible evidence of them causing significant harm' ^[6]. The EACD report notes that

“One case study has been reported in which a 23 year old woman died 68 hours after ingesting BZP and 64 hours post ingestion of MDMA and a large volume of water (Balmelli C. et al. 2001). No linkage with the BZP was made and the death displayed all the characteristics of an ecstasy related death. She was diagnosed with cerebral oedema and with beginning tonsillar herniation. This case, was considered by the United States federal authorities (DEA) as evidence of BZP's potential to cause death (even though no causal links were established, the substance was implicated by its presence), and led to BZP being placed in schedule 1 in 2002. Other than this one case, no other fatalities are known of, therefore BZP's known potential to cause death is low , or as yet unknown”.[Transform emphasis]
Regards the drugs potency The EACD report states that

“Although BZP is known to have a similarity of action to dexamphetamine, it is considered to be approximately ten percent of the potency. It is unlikely that users would attempt to match the dose strength of d-amphetamine as unwanted and unpleasant side effects are experienced at about 2 ½ times the average dose. (Average. dose = 100 mgs BZP) The duration of action for a 100mg dose is 6 to 8 hours.”
The US Drug Enforcement Agency apparently made mistaken claims about its potency;

“BZP acts as a stimulant in humans and produces euphoria and cardiovascular changes including increases in heart rate and systolic blood pressure. BZP is about 20 times more potent than amphetamine in producing these effects. However, in subjects with a history of amphetamine dependence , BZP was found to be about 10 times more potent than amphetamine. ” ^[7]
In 2004 the DEA produced a revised BZP profile stating:

“BZP acts as a stimulant in humans and produces euphoria and cardiovascular effects, namely increases in heart rate and systolic blood pressure. BZP is about 10 to 20 times less potent than amphetamine in producing these effects .” ^[8]
There seems to be no physically addictive properties to either BZP or TFMPP. The EACD report states (adding a cautionary note) that:

“No evidence of physical dependence has been described with the substances being used orally. There is no reference to the injecting route being favoured. Development of tolerance may occur, but higher doses are associated with increased unwanted side effects. There is some possibility for a mild psychological dependence to develop due to repeated self administration and the subsequent reliance upon the subjective effects to overcome inhibitions or to give the energy/wakefulness required to participate in the social environment, particularly within the urban dance environment .”
A feature in the New Scientist (Sept 2006 – linked below) reports on studies that monkeys will self-administer BZP. There does not, however, appear to be any evidence of patterns of problematic dependent use emerging amongst humans.
The drugs appear to be very dose specific – with desirable effects in a comparatively narrow dosage threshold, over which unpleasant effects appear. Upping dosage (a familiar pattern of use with MDMA) to get a more intense effect is best avoided and unlikely to be repeated. Users also report that re-dosing when effects start to dissipate is ineffective and also causes unpleasant side effects. In the longer term these qualities will have a self-limiting effect on the drugs potential harms.
Side effects are known to include – severe agitation, nausea (lessened if taken on a full stomach), seizures, paranoia, hyperthermia, abdominal pain, and cardiac arrhythmias. Effects from longer-term use are not known.
Both BZP and TFMPP are diuretics; therefore users should make sure that they are well hydrated when using them. This is especially important if they are drinking alcohol at the same time (something which isn't recommended, but does appear to be widespread). There is a small danger of hyponatremia (water toxicity) from over drinking, especially because dry mouth is a documented effect.
The EACD report acknowledged both that: “ Piperazine users conditioned to the effects of stimulants may more readily transfer to harmful illicit street drugs” and that “ Substitution of illicits with Piperazines is occurring, mostly amongst users who are afraid of the damage to their lives that a conviction would bring and who also wish to normalise the transaction required to purchase their choice of recreational substance”. The extent of either of these effects and there net impact is unknown.

Contra indications:

Mixing these drugs with absolutely anything other than just water is probably a bad idea that will undoubtedly increase risks.
Issues identified in the EACD report for either prescription SSRI's or MAOI's – which can cause serotonin syndrome and a rise in blood pressure.
Their effect when used with MDMA is unknown but should also be strongly discouraged.
Mixing with depressants, including alcohol or Benzodiazapines should be discouraged in line with advice on mixing stimulants and CNS depressants.

Transform's relationship with piperazine retailers

Transform in keen to reiterate that we are in no way advocating on behalf of any business interests, our only concern being to call for effective regulation of potentially harmful recreational drugs as a way of minimising harms to users and the wider community. The role of the suppliers and retailers is central to the debate around possible regulatory models and they will clearly need to be involved in discussions as they are in Regulatory impact assessments. Transform has had limited phone and email contact with the main UK importers/suppliers (Spiritual Highs- who drew our attention to recent developments on this issue), and as a way of establishing the details of the current UK situation. Transform has received no funding from any commercial enterprises involved.

References / Notes

http://www.drugs.gov.uk/publication-search/acmd/pathways-to-problems/
See http://www.spiritualhigh.co.uk/
Transform does not accept the term ‘social tonics' as appropriate for piperazines or any recreational drug.
http://www.drugs.gov.uk/news-events/latest-news/khat-recommendations
http://www.publications.parliament.uk/pa/cm200506/cmselect/cmsctech/1031/103102.htm p.36
http://www.stanz.org.nz/SOP%20Submission%20for%20STANZ%20%20-%20Jan%2020052.pdf
Final Federal Register declaring BZP to be a prohibited substance; http://www.deadiversion.usdoj.gov/fed_regs/rules/2004/fr0318.htm
http://www.deadiversion.usdoj.gov/drugs_concern/bzp_tmp/bzp_tmp.htm

Transform Drug Policy Foundation, Easton Business Centre, Felix Rd., Bristol, BS5 0HE, Telephone: +44 (0) 117 941 5810

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