Bristol Imperial MDMA in Alcoholism Study

NCT ID: NCT04158778

Last Updated: 2019-11-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-18
• Study Completion Date: 2020-06-12

Brief Summary

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

Detailed Description

This is an open label within-subject feasibility study, in 20 patients with Alcohol Use Disorder who have recently undergone detoxification. All patients will receive MDMA-Assisted drug therapy. This study aims to assess if MDMA-Assisted Psychotherapy can be delivered safely and can be tolerated by patients with alcohol use disorder post-detoxification. Outcomes regarding abstinence from alcohol, quality of life and psychosocial functioning will be evaluated.

Conditions

Alcohol Use Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MDMA assisted Psychotherapy

All participants receive 2 sessions of MDMA-assisted psychotherapy

Group Type: EXPERIMENTAL

MDMA

Intervention Type: DRUG

Two sessions of MDMA-assisted psychotherapy will take place (session 3 \& 7) within the 10 week course of psychotherapy. An initial dose of 125mg MDMA will be followed by an optional dose of 62.5mg 2 hours later.

Psychotherapy

Intervention Type: OTHER

Two sessions of MDMA-assisted psychotherapy will take place (session 3 \& 7) within the 10 week course of psychotherapy.

Interventions

MDMA

Two sessions of MDMA-assisted psychotherapy will take place (session 3 \& 7) within the 10 week course of psychotherapy. An initial dose of 125mg MDMA will be followed by an optional dose of 62.5mg 2 hours later.

Intervention Type: DRUG

Psychotherapy

Two sessions of MDMA-assisted psychotherapy will take place (session 3 \& 7) within the 10 week course of psychotherapy.

Intervention Type: OTHER

Other Intervention Names

3,4-methylenedioxymethamphetamine

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prof Nutt

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

Study Center: University of Bristol

Bristol, , United Kingdom

Countries

United Kingdom

References

Thurgur H, Sessa B, Higbed L, O'Brien S, Durant C, Wilson S, Szigeti B, Morgan CJA, Nutt DJ. MDMA-assisted psychotherapy for AUD: Bayesian analysis of WHO drinking risk level and exploratory analysis of drinking behavior and psychosocial functioning at 3 months follow-up. Alcohol Alcohol. 2025 May 14;60(4):agaf031. doi: 10.1093/alcalc/agaf031.

Reference Type: DERIVED

PMID: 40492610 (View on PubMed)

Other Identifiers

2016-002547-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BIMA2016

Identifier Type: -

Identifier Source: org_study_id