Alcohol Use Disorder MedDRA version: 19.0 Level: LLT Classification code 10001594 Term: Alcohol dependence syndrome System Organ Class: 100000004873
Conditions
Interventions
Product Name: 3,4-methylenedioxmethamphetamine (MDMA)
Pharmaceutical Form: Capsule
INN or Proposed INN: 3,4-methylenedioxymethamphetamine
CAS Number: CAS-42542-10
Concentration unit: mg milligram(s)
C
Sponsors
Imperial College London, Joint Research Compliance Office
Eligibility
Sex/Gender
All
Inclusion 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 and provide supervision after drug-assisted sessions. -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. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
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; • Relevant abnormal clinical findings at screening visit judged by the investigator to render subject unsuitable for study. Including but not limited to: o History of cardiac disease, hypertension and stroke o History of severe liver disease, as evidenced by abnormal liver function test results, particularly reduction in albumin (normal > to 3.5 gm/dl). o History of epilepsy; o 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 (during 8 week MDMA assisted therapy only): o Must use an effective form of birth control during the study. o Must not be breast-feeding. • Taken part in a study involving an investigational product in the last three months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This is a proof of concept feasibility study assessing if MDMA-Assisted Psychotherapy can be delivered safely, and is tolerated and acceptable to patients with alcohol use disorder who have recently been detoxified from alcohol. ;Secondary Objective: The secondary objectives are to assess the effect of MDMA-assisted psychotherapy on drinking behaviour, psychosocial functioning and quality of life. ;Primary end point(s): This is proof of concept open label, feasibility study exploring the tolerability, acceptability and use of MDMA-assisted psychotherapy. The main outcome measure for this study will be safety and tolerability as measured by: • Any adverse events during the treatment period • Number of patients completing 8-week course of MDMA-assisted psychotherapy. • Number of patients accepting second booster dose of MDMA during drug-assisted psychotherapy sessions. ;Timepoint(s) of evaluation of this end point: These outcome measures will be assessed during and at the end of the treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): During the course of 8-week therapy: • Intensity of MDMA drug effect on dosing days (VAS/SUDS) • Subjective sleep rating the night following dosing (Leeds Evaluation Questionnaire). • Mood ratings over 5 days following MDMA; (Positive and Negative Affect Scale). • At the end of the 8 weeks: acceptability of MDMA-Assisted therapy program At 3*, 6* and 9* months, the following will be assessed, using standardised scales, the Time Line Follow-Back drink diary method and clinical interview, supported by monthly phone calls; • Drinking behaviour (where Day 0 = completion of the detoxification program), specifically: • Number of cumulative non-drink days • Rate of complete abstinence from alcohol • Quantity of alcohol consumed on drinking days (if drinking) • Number and % of heavy drinking days compared to baseline (if drinking) • Quality of life, including subjective sleep • Psychosocial functioning • Prescribed medication use • Number and frequency of recreational drugs (if any) • Craving relating to MDMA and any subsequent use of illicit ecstasy. • Assessment of ability to collect follow-up data (ease of contacting patients/ number of calls made etc.). *As this is a feasibility study we will assess the success of collecting information at follow up. It may not be possible to contact all patients at all time points, especially at 9 months. ;Timepoint(s) of evaluation of this end point: These outcome measures will be assessed during and at the end of the treatment period, and for follow-up measures at 3,6 and 9 months as stated above and in the protocol. | — |
Countries
United Kingdom
Contacts
Public ContactDavid Nutt
Imperial College London
Outcome results
None listed