MDMA: Roadmaps to Regulation – Executive Summary

MDMA is well established as a popular psychoactive substance across much of the Western world. Hundreds of thousands of people break the law to access its effects, which include increased energy, euphoria, and enhanced sociability. The categorisation of MDMA as a Class A drug in the UK and Schedule I drug internationally – categories reserved for drugs deemed to pose the highest risk to individuals and society – has never meaningfully disrupted its supply, nor its widespread use. MDMA is cheaper and purer than ever before and is available at the click of a mouse via darknet drug markets.

For several years, MDMA-related adverse events and fatalities have been increasing in the UK, with some claiming that taking MDMA today is the riskiest it has ever been. Responses are polarised between those who assert that the risks of MDMA use necessitate mitigation through prohibition and increased law enforcement, and those who perceive prohibition to be exacerbating these risks by exposing users to an unregulated market of pills and powder of unknown strength and quality. Whichever view you take, current policy is not meeting its goal of reducing harms, and greater control of MDMA production, distribution, purchase, and consumption is needed in order to prevent MDMA-related emergencies.

This report examines the acute, sub-acute, and chronic harms related to MDMA use in detail. We examine the production, distribution, purchase, and consumption of the drug; related risks and harms; and the impact prohibition has on these, as well as the potential impact of alternative policies. Crucially, our evidence shows that most harms associated with MDMA use arise from its unregulated status as an illegal drug, and that any risks inherent to MDMA could be more effectively mitigated within a legally regulated market.

Under prohibition, people purchase MDMA pills, crystal, and powder from an illegal market, with little certainty as to what these contain. Given that illegal drugs are not subject to strict production standards, consumers are exposed to the risks of poisoning or accidental overdose as a result of contamination, adulteration, and unknown strength and purity. Naïve commentators demonise the drug and simply urge young people to ‘just say no’, whilst failing to account for those who say ‘yes’. In the meantime, preventable deaths continue to occur, and otherwise law-abiding people are punished for non-violent offences such as the possession or social supply of MDMA. Governments and the mainstream media persist in perpetuating the myth that the War on Drugs is winnable if it were fought harder, and those calling for drug policy reform – as we do here – are framed as ‘radicals’ who have little or no regard for the health and wellbeing of citizens.

This characterisation could not be further from the truth. Those calling for careful reform to existing drug policy include the parents of young people whose lives have been lost or ruined by harms related to the prohibition of MDMA. We incorporate their voices in this report alongside those of academics and former police officers, highlighting the ‘broad church’ of those dedicated to fighting for reform. This includes scientists undertaking ground-breaking research into the therapeutic potential of MDMA, who work within a regulatory regime that makes such research exorbitantly expensive and time-consuming, because of the Schedule 1 status that MDMA holds in the UK.

As we enter the fourth decade of MDMA’s widespread use, new thinking is needed on how to better control production and distribution, and on how to reduce the risks associated with its consumption. There is growing evidence to support reorienting drug policy away from an ideologically driven criminal justice-led model to one rooted in pragmatic health and harm reduction principles. This is reflected in the widespread reform of cannabis laws occurring in numerous jurisdictions around the world, and the growth of treatment programmes for heroin users which include prescription heroin and supervised injecting rooms. These hard-fought policy changes acknowledge the failure of prohibition to meet its goals and produce a ‘drug-free world’. They are built on a robust and ever-growing evidence base which demonstrates how permitting or prescribing the use of legally regulated drugs improves health and safety outcomes for people who use drugs and their communities at a reduced cost to the state, whilst also providing wider employment and economic opportunities. This logic can be extended to the use of MDMA and other currently prohibited psychoactive substances.

Roadmaps to Regulation: MDMA follows this pragmatic path and pursues policy aims which many of us share, such as improvements in public health promotion, targeted harm reduction, evidence-informed policy and practice, human rights, social justice, participatory democracy, and effective governmental expenditure. For the first time, we outline detailed recommendations for drug policy reform to better control the production, distribution, purchase, and consumption of MDMA products. Reform and the reduction in MDMA-related harms this will bring cannot happen overnight. The changes we outline here, which culminate in a strictly regulated legal market for MDMA, are to be phased in gradually and closely evaluated through independent policy research to ensure health and social outcomes are properly documented, with findings folded back into the ongoing reform process.

As with all drugs, certain adverse effects can be caused by or associated with
MDMA use. The most serious of these include hyperthermia, hyponatraemia
(abnormal water regulation which causes swelling in the brain), serotonin
syndrome, and isolated physiological disorders such as cardiac events and liver
failure, all of which may result in death. These adverse effects occur through
various mechanisms, none of which is as simple as an ‘overdose’. Whilst it
is widely accepted that risks are increased with higher doses of MDMA,
there is no established consensus on the fatal blood concentration level of
MDMA, and it is often unclear to what extent the harms are attributable
to the toxicity of MDMA alone, or to the circumstances in which it is taken.

Hyperthermia is the most commonly reported life-threatening medical
complication associated with MDMA use. The risk for users is exacerbated by
external factors. These include dancing for prolonged periods in overcrowded
venues with high ambient temperatures and insufficient ventilation, although
risks may not be confined to dance settings. MDMA increases metabolic
heat generation and impairs heat dissipation through vasoconstriction,
which typically increases body temperature in a manner comparable to
moderate exercise. When paired with other heat-generating activities, severe
problems can arise for a small but significant number of people.

Hyponatraemia, another MDMA-related medical complication that has
resulted in fatalities, is caused by excessive water intake, often ingested
in order to prevent dehydration and overheating following MDMA
consumption. MDMA causes the brain to release certain chemicals (e.g.,
arginine vasopressin) that tell the body to retain water, which is problematic
if an excess of water is subsequently consumed.

Both hyperthermia and hyponatraemia could be prevented with
comprehensive harm reduction advice and services. Neither adverse effect
has ever occurred in a clinical setting.

Unlike other recreational legal and illegal drugs such as cannabis and alcohol,
occasional use of MDMA is typical. Prolonged daily use – an indicator of
problematic use – is atypical and usually only associated with co-occurring
mental or physical conditions. Given this, harms associated with chronic
use of MDMA may only be relevant for a minority of MDMA users.

It remains difficult to define conclusively the risks associated with long-term
regular use of MDMA, due to multiple confounding factors (e.g., polydrug
use, including mixing MDMA with alcohol; purity of MDMA products;
and use setting) and the fact that the only available evidence comes from
animal experiments, observational studies of human users, and accounts of
harm such as clinical case reports. Of these, only the animal experiments
have gathered data on the effects of the use of pure MDMA.

However, proposed neuropsychological risks include neurological and
cognitive impairment, psychological and mood problems, and sleep
disturbances, which some claim are the result of direct neurotoxicity. The
neurotoxicity of MDMA continues to be strongly debated but there is
evidence to suggest that heavy use of MDMA may contribute to temporary
impairments in neuropsychological functions. Liver toxicity has also been
reported, although it is impossible to ascertain whether this was driven
primarily by MDMA, or was the result of polydrug use or of an adulterated
product.

The number of MDMA-related deaths has been rising in the UK since 2010.
This has been mirrored by an increase in ‘high-dose’ MDMA/‘Ecstasy’ pills and
powders in circulation, and the presence of high-risk adulterants such as PMA
(paramethoxyamphetamine) and PMMA (paramethoxymethamphetamine)
in pills sold as MDMA. Recent drug-testing results by the harm reduction
organisation The Loop (UK) have identified pills containing as much as 300
mg of MDMA, which is considerably more potent than in previous years.
Although the relationship between dose and adverse effects is complicated
and cannot be divorced from the user and the user’s setting, a significant
proportion of MDMA-related medical emergencies and deaths are cases of
accidental poisoning through unintentional excessive doses and adulteration
with, or substitution of, other substances.

Assessing the risk profile of MDMA requires distinguishing between
MDMA of clinical purity and MDMA produced and sold illegally. It also
requires identifying the risks specifically related to the context in which
the drug is consumed. Recreational MDMA use has only been studied
under conditions of prohibition, and so the evidence can only tell us, at
best, how risky MDMA may be in that specific context. Aside from the
pre-prohibition era of MDMA use, recreational users have not had access
to a pure standardised MDMA product, so we cannot know for certain
what harms, at what levels, would be attendant to that scenario. We know
that clinical-grade MDMA can be administered with a high degree of
safety in a controlled therapeutic setting if sufficient measures are taken to
reduce risks: over 1,500 people have participated in studies investigating the
effects and therapeutic use of MDMA with no unexpected serious adverse
events requiring emergency treatment reported. Although recreational
use is distinct from therapeutic use, clinical research helps us to better
understand any risks associated with pure MDMA and how these risks
can be managed.

Currently in the unregulated criminal market, MDMA potency and purity is highly variable: pills have been found containing less than 20 mg of MDMA while others contain more than 300 mg of MDMA. MDMA may also contain adulterants that are psychoactive and/or toxic. As users are unaware of the content of their pills, they may be vulnerable to overdosing or other problems caused by product adulteration, particularly if they choose to consume multiple pills. The lack of consistency makes it difficult to establish stable social norms, moderate use, and harm reduction measures, although over the last 30 years of rave and dance culture, specific grassroots risk mitigation measures, such as breaking pills into quarters, have emerged. Ultimately people who take MDMA want to stay safe.
The variability in MDMA potency and purity is a direct result of global and national prohibitionist policies. Recent developments in in situ drug safety testing are an attempt to mitigate the risks of such variability. These risks, such as overdose and/or poisoning, are by no means inevitable or inherent to the drug. If MDMA were clinically produced and legally distributed, users would be assured of the product content and appropriate dosage, and be able to make more informed decisions regarding their MDMA use. In this way the principal risks we associate with MDMA use would be greatly reduced.
Prohibition makes users less likely to seek medical assistance for fear of ‘getting into trouble’ with the authorities, especially amongst members of marginalised communities who already receive disproportionate law enforcement attention relative to their involvement in drug markets. Young people may be reluctant to contact emergency services if they, or a friend, experience an adverse reaction to a substance, out of fear of repercussions in relation to social dealing and/or potential media coverage of their role in the incident.
Pressures on MDMA users to avoid detection and on nightclubs, warehouse parties, and festivals to demonstrate zero-tolerance create conditions that are not conducive to responsible use. Intensive searches and drug (sniffer) dogs may unintentionally encourage users to take all their drugs at once before entering. This has led to several young people accidentally overdosing as a result of not wanting to be caught with their drugs ‘on the door’ of nightclubs or events. Avoiding such detection can also lead people to purchase their drugs from unknown dealers inside the venue who, in comparison to dealers known by the user, may offer an even more unpredictable product. The ‘zero-tolerance’ approach of certain venues or events can lead people to consume MDMA in less regulated private parties or unlicensed venues, where an MDMA-related emergency may take longer to receive medical attention.
Adolescents and those with pre-existing genetic vulnerabilities, or with specific health diagnoses that may be contraindicated for MDMA use (such as heart conditions or impaired liver function) are not protected by prohibition. There are no age restrictions in a criminal market, no education at point of sale on the risks associated with various products, and no purchase limits to curb heavy use or ‘bingeing’.
The development of online drug sales via darknet markets and social media dealing poses specific kinds of risks and opportunities in addition to the more familiar practice of purchasing drugs from criminal markets. The internet has created an easily accessible supply route for ‘tech-savvy’ young people who may not otherwise have had access to street or social dealers; this may increase MDMA availability for certain populations. However, for some people, online modes of purchase may be preferable given that they avoid the need to meet dealers in person, and there is some degree of quality control through user ranking/reports on vendors.
Harm reduction is restricted within a prohibitionist policy regime because the dominant focus is on drug prevention and abstinence rather than safer use. Risks such as hyperthermia and hyponatraemia are exacerbated by certain contexts of use and environmental factors. Under prohibition, venues and events are supposed to operate with a ‘zero-tolerance’ approach to drug taking. For the most part, they are under no obligation to provide basic harm reduction measures, such as visible free drinking-water supplies and adequate ventilation and temperature control, let alone measures such as in-house medics and pill checking that could further prevent adverse effects. Indeed, venues and events may be stigmatised for taking a more ‘tolerant approach’ should an MDMA-related emergency occur.
The opportunity for education at point of sale, or information campaigns to raise awareness of the risks associated with MDMA use for certain populations and the relative risks of different dosages and contexts of use, is completely lost within an illegal market. Likewise, the lack of regulations for MDMA producers and distributors means they may remain largely ignorant of the harms to health posed by certain production techniques or the presence of certain contaminants in the products they make and sell.

Prohibition has created a lucrative illegal MDMA market that generates wealth for entrenched criminal organisations and criminal entrepreneurs. Those involved in large-scale production, importation, or distribution of MDMA and other illegal drugs are likely to engage in other criminal behaviour as part of their business practice, for example, violence towards consumers and rivals, money laundering, and corruption.
There is no evidence to suggest that criminalising people who use drugs meaningfully disrupts the supply of controlled drugs or reduces their availability. However, criminalising (often young) MDMA users can have a devastating impact on their lives, resulting in the loss of education or employment opportunities; negatively impacting housing, personal finance, and social relationships; and, ironically, potentially increasing the likelihood of them developing more problematic drug-using behaviour, especially if they spend time in prison.
Many people who use MDMA report obtaining their drugs from friends and established contacts. This creates a risk of criminalisation for young people engaging in non-profit ‘social supply’ amongst peer groups, or small-scale opportunistic dealing. Drug dealing can also attract young people in situations of social vulnerability, which can further perpetuate cycles of harm, trauma, and exclusion if they are prosecuted. The harms of criminalisation are arguably greater than the harms caused by occasional use of MDMA.
The development of markets for novel psychoactive substances (NPS) intended to mimic the effects of MDMA is directly related to the drug’s illegal status. Illegal production results in a market affected by inconsistent quantity and quality of production. If MDMA supplies run scarce due to law enforcement measures or the quality diminishes due to production difficulties, alternatives are sought. A decade ago, NPS as legal replacements for MDMA swiftly emerged, with some MDMA users simply adding them to their polydrug repertoires. NPS such as mephedrone, a stimulant which enjoyed immense if short-lived popularity in the UK, turned out to have a higher risk profile than MDMA, was banned in 2010, and now plagues marginalised stimulant users. NPS are the genie that prohibition let out of the bottle.

Before the use of MDMA was prohibited, it was employed by psychotherapists as a valuable and effective tool to augment the psychotherapeutic process, particularly for overcoming fear and anxiety associated with trauma, and in the context of couples’ therapy. Due to the regulatory hurdles imposed by the prohibition of MDMA, research into this particular use of MDMA was seriously impeded for almost twenty years. Only recently has it been revived, largely due to the efforts of the Multidisciplinary Association for Psychedelic Studies. Phase 1 and Phase 2 clinical trials of the use of MDMA in the treatment of post-traumatic stress disorder have been completed with positive results, and Phase 3 trials are now underway following the US Food and Drug Administration approval and designation of MDMA as a ‘breakthrough therapy’ for post-traumatic stress disorder.
Other research is being conducted to see whether MDMA-assisted psychotherapy can help autistic adults with social anxiety, patients with anxiety relating to a life-threatening illness, and people with alcoholism. Prohibition imposes considerable financial and bureaucratic obstacles to preclinical and clinical research involving prohibited drugs, resulting in trials taking longer and costing more – as much as ten times the equivalent research with unprohibited drugs such as alcohol. A gram of clinically made MDMA can cost researchers in the UK £10,000 as compared to its average street price of £30–£40 per gram.

Moving to a strictly regulated commercial market may take time as political,
legal, and practical hurdles need to be overcome. Thus, we propose the following
interim measures to reduce some of the harms associated with the current system:

Reschedule MDMA from a Schedule 1 to Schedule 2 drug under the Misuse
of Drugs Regulations in the UK, and equivalent legislation internationally.
This will reduce the political, bureaucratic, and cost barriers to scientific
research associated with the Schedule 1 status and facilitate further research
into MDMA’s therapeutic uses, as well as allowing us to improve our
understanding of its physiological effects.
Decriminalise the possession of MDMA and all drugs to remove the
devastating social and economic effects of being criminalised for drug
possession or limited social supply. As well as improving social justice
outcomes for users of MDMA (a principal aim of any drug policy),
decriminalisation will improve health outcomes by removing barriers to
harm reduction and health services, and increasing willingness to access
them amongst vulnerable populations who might have previously feared
legal repercussions. To reap the full benefits that could be derived from
decriminalisation and to help tackle the disproportionality and racial
bias of drug policing, it is appropriate that criminal penalties be removed
for the possession of any drug (and not solely MDMA), as is the case
in Portugal.
Through decriminalisation, enable the comprehensive rolling-out of drug
safety checking and other successful harm reduction interventions to occur,
which would go some way towards reducing the harms associated with
unregulated MDMA products.

Licences would be awarded to selected pharmaceutical manufacturers to produce MDMA certified by Good Manufacturing Practices (GMP). This would ensure product safety and quality and resolve the current issue of adulterants. All MDMA products would be labelled with clear indications for dosage, contraindications, and potential adverse events.
Licensed MDMA products would be sold in government-licensed MDMA product outlets. These outlets could be pharmacies in the first instance. Pharmacies are uniquely positioned as gatekeepers for controlled drugs. Regulated pharmacy sales would enable the retail of MDMA products to be governed by strict regulatory legislation and a well-defined quality assurance infrastructure.
Point-of-sale face-to-face discussion is crucial for harm reduction. MDMA product outlet staff (initially pharmacists in our incremental model for policy change) would be specially trained to educate customers on the risks associated with MDMA use. Take-home educational material promoting harm reduction would also be available.
Adults who wished to purchase MDMA products would be required to obtain a ‘personalised licence’ to do so. This licence would only be available to those who had first discussed the risks of MDMA use with a trained pharmacist. Personalised licences would be conditional on adults being able to demonstrate that they understand the risks and how to minimise them. They would be reviewed on an annual basis.
The development of adult-only MDMA-friendly spaces could provide an environment in which the risks associated with MDMA use could be further mitigated through well-established harm reduction measures and requirements for on-site medical assistance. These venues would need to incorporate procedures to minimise risks and promote responsible MDMA use, such as ensuring that dancefloors are cool and well ventilated, and that customers exhibiting adverse symptoms quickly receive medical help. Alcohol-free venues could be trialled as a means of encouraging single-substance use. Alcohol impairs inhibitory control making it easier for people who use drugs to consume drugs faster and in higher quantities than they had intended.
User controls are essential for supporting the responsible use of MDMA. Controls would aim to minimise the use of MDMA by vulnerable populations, reduce polydrug use (including the mixing of alcohol and MDMA), encourage safer modes and patterns of consumption, and improve user understanding of the potential harms associated with MDMA consumption. User controls would include a strictly enforced age limit, pricing controls, mandated health information on packaging and at point of sale, childproof and tamperproof packaging, a comprehensive ban on marketing and advertising, and a campaign to minimise the social acceptability of driving under the influence of MDMA and to promote alternatives such as designated drivers.
Sales of MDMA would be permitted to adults over 18 years of age. Prohibitive penalties would be in place to restrict underage sales.
Information campaigns focusing on MDMA safety and responsible use would be central to the development of a regulated legal market. Such information campaigns would cover all sales outlets and educational establishments (schools, colleges, and universities), and would include information on recognising the symptoms of adverse events in relation to MDMA products and how to manage them.
Thorough monitoring and evaluation of the impact of legislative change would be undertaken to maintain an evidence-based approach and allow responses ‘on the ground’ to feed back into policy decision making.

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