Bristol Imperial MDMA in Alcoholism Study

NCT04158778 | Unknown Phase 1

• 2 other identifiers: BIMA20162016-002547-42
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alcohol Use Disorder

Keywords

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability as measured by adverse event

  Number of patients completing 8-week course of MDMA-assisted psychotherapy. * Number of patients accepting second booster dose of MDMA during MDMA drug- assisted psychotherapy sessions. * All adverse events/reactions during the study will be tabulated, serious adverse events/ reactions will be coded according to CTCAE v4. The number of participants with treatment-related adverse events during the treatment period will be reported.

  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).

Secondary Outcomes (23)

• Intensity of MDMA drug effect during MDMA-assisted psychotherapy sessions

  MDMA-assisted psychotherapy sessions, at dosing and hourly for up to 8 hours after dosing.

• Degree of psychological (subjective) distress (SUDS), participant and observer scores

  MDMA-assisted psychotherapy sessions, -1 hour before dosing, at dosing and hourly following dosing for 8 hours. P

• Change in Vital signs during MDMA-assisted psychotherapy sessions: Heart Rate

  MDMA-assisted psychotherapy sessions: 1 hour before dosing, at dosing, every 30 mins for 2 hours and hourly thereafter for 6 hours (extra measures taken if clinically required).

• Change in Vital signs during MDMA-assisted psychotherapy sessions: Temperature

  MDMA-assisted psychotherapy sessions: 1 hour before dosing, at dosing, every 30 mins for 2 hours and hourly thereafter for 6 hours (extra measures taken if clinically required).

• Change in Vital signs during MDMA-assisted psychotherapy sessions: Systolic Blood pressure

  MDMA-assisted psychotherapy sessions: 1 hour before dosing, at dosing, every 30 mins for 2 hours and hourly thereafter for 6 hours (extra measures taken if clinically required).

Study Arms (1)

MDMA assisted Psychotherapy

EXPERIMENTAL

All participants receive 2 sessions of MDMA-assisted psychotherapy

Drug: MDMA; Other: Psychotherapy

Interventions

MDMA 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.

Also known as: 3,4-methylenedioxymethamphetamine

MDMA assisted Psychotherapy

Psychotherapy OTHER

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

MDMA assisted Psychotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Study Center: University of Bristol

Bristol, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 40492610 DERIVED

MeSH Terms

Conditions

Alcoholism

Interventions

N-Methyl-3,4-methylenedioxyamphetamine; Psychotherapy

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals; Behavioral Disciplines and Activities

Study Officials

• Prof Nutt

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label

Study Record Dates

• First Submitted: January 31, 2019
• First Posted: November 12, 2019
• Study Start: April 18, 2018
• Primary Completion: June 12, 2020
• Study Completion: June 12, 2020
• Last Updated: November 12, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)