Bristol Imperial MDMA in Alcoholism Study

• Status: Unknown status
• Trial end date: 2020-06-12
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Imperial College London
• Treatments: N-Methyl-3,4-methylenedioxyamphetamine

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).