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Unknown statusPhase 1

Bristol Imperial MDMA in Alcoholism Study

NCT04158778 · BIMA · Imperial College London

Closed to entry
Status
Not accepting participants
Phase 1
Phase
20
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

The Safety, Tolerability and Role of MDMA-Assisted Psychotherapy for the treatment of detoxified patients with Alcohol Use Disorder.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Safety and tolerability as measured by adverse event

    Measured over Treatment period defined as: From first attendance for a psychotherapy session (Session 1) to the last psychotherapy session (session 10, approximately 8 weeks from treatment start).

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria * Informed consent * Primary diagnosis (as defined by DSM-5) of alcohol use disorder. * Successful alcohol detoxification (no longer consuming any alcoholic substances). * Between 18 and 65 years old. * Be able to identify in advance a supportive significant other(s): * who could accompany the patient to study visits if required -who can be contacted by the study team in order to remind the patient about follow- up appointments or collect outcome data (such as drinking behaviour) in the event that the patient themselves cannot be contacted. * Proficient in speaking and reading English. * Agree to comply with requirements of protocol. Exclusion Criteria * Lacking capacity * History of, or a current, primary psychotic disorder, bipolar affective disorder type 1 or personality disorder; * Present a serious suicide risk; this will be determined using the clinical judgement of the qualified mental health professionals within the research team. They will use information from the Columbia-Suicide Severity Risk Scale (C-SSRS) which allows classification of severity of suicidal ideation and behaviour. This scale classifies severe risk as a) current suicidal ideation with intent and/or plan; b) suicidal behaviour in the last 3 months. A clinical judgement regarding the level of risk and subsequent decisions regarding eligibility and care would use a combination of the information provided by the C-SSRS, the participant's history of previous risk behaviours, any presenting mental health difficulties and environmental and clinical factors. A final decision would usually include a discussion with qualified mental health professionals within the research team. * Relevant abnormal clinical findings at screening visit judged by the investigator to render subject unsuitable for study. Including but not limited to: * History of cardiac disease, hypertension and stroke * History of severe liver disease, as evidenced by abnormal liver function test results, particularly reduction in albumin (normal \> to 3.5 gm/dl). * History of epilepsy; * History of Malignant Hyperthermia (Central Core Disease); * Regular user of Ecstasy (material represented as containing MDMA). E.g. more than five times in the last five years or at least twice in the 6 months prior to the start of the study; * Currently taking or unwilling/unable to stop any medications inhibiting CYP 2D6, and the following medications Monoamine Oxidase Inhibitors, Ritonavir (HIV treatment), paroxetine, fluoxetine, citalopram, regular benzodiazepines or any other medications likely to interact with MDMA the opinion of the investigators, during 8 week MDMA assisted therapy only * Regular use of/dependence on other drugs such as benzodiazepines, synthetic cannabinoids, cocaine and heroin. * For females of childbearing age/potential * Must use an effective form of birth control for at least six days after administration of MDMA * Must not be pregnant and/or breast-feeding, until the end of the treatment phase. * For males with partners of childbearing age/potential * Must themselves confirm use of an effective form of birth control for at least six days after administration of MDMA and confirm their partner will also, defined in detail in protocol. * Taken part in a study involving an investigational product in the last three months * Patients that might face additional risks from immunosuppression (for example patients with immunological diseases, patients with active infection or history of infections within 4 weeks of MDMA administration, etc).

Where

1 study site

FacilityCityRegionCountry
Study Center: University of BristolBristolUnited Kingdom

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT04158778 on ClinicalTrials.gov →

Last updated in the registry 2019-11-12. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits