Open-Label Proof of Concept Feasibility Study to Explore the Safety, Tolerability and Potential Role of MDMA-Assisted Psychotherapy for the Treatment of Detoxified Patients With Alcohol Use Disorder
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Imperial College London
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Safety and tolerability as measured by adverse event
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
MDMA assisted Psychotherapy
All participants receive 2 sessions of MDMA-assisted psychotherapy
Intervention: Psychotherapy (Other)
MDMA assisted Psychotherapy
All participants receive 2 sessions of MDMA-assisted psychotherapy
Intervention: MDMA (Drug)
Outcomes
Primary Outcomes
Safety and tolerability as measured by adverse event
Time Frame: 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).
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.
Secondary Outcomes
- Subjective sleep following MDMA assisted psychotherapy(Daily for 7 days following both MDMA-assisted psychotherapy sessions (session 3 and 7).)
- 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: 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).)
- Mood rating during 7 days following MDMA assisted psychotherapy(Daily for 7 days following both MDMA-assisted psychotherapy sessions (session 3 and 7).)
- Acceptability of MDMA-Assisted therapy program: questionnaire(2 months , completed at psychotherapy therapy sessions (1,2,3,4,5,6,7,8,9 & 10))
- 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.)
- Change in Vital signs during MDMA-assisted psychotherapy sessions: Diastolic 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).)
- Change in Drinking behaviour(Baseline, Screening (day 0), Completed at psychotherapy therapy sessions, 1,2,3,4,5,6,7,8,9 & 10', Follow-up 3, 6, 9 months)
- Change in Subjective Sleep Quality: PSQI(Screening (day 0), 3, 6 and 9 months)
- Prescribed medication use(Screening (day 0), 3, 6 and 9 months)
- Assessment of ability to collect follow-up data(Follow up 3,6 and 9 months)
- Trauma History Questionnaire (THQ)(2 month (Session 10))
- 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: 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).)
- Change in psychosocial functioning: Short Inventory of Problems for Alcohol (SIP)(Screening (day 0), 3, 6 and 9 months)
- Change in psychosocial functioning: The Patient Health Questionnaire (PHQ-9)(Screening (day 0), 3, 6 and 9 months)
- Change in Quality of Life: SF-36(Screening (day 0), 3, 6 and 9 months)
- Change in psychosocial functioning: Generalized Anxiety Disorder 7 (GAD-7)(Screening (day 0), 3, 6 and 9 months)
- Change in psychosocial functioning: The self compassion scale (SCS)(Baseline, psychotherapy session 10 (final psychotherapy session), follow-up visits at 3, 6 and 9 months)
- Change in psychosocial functioning: Interpersonal reactivity Index (IRI)(Baseline, 3, 6 and 9 months)
- The Penn Alcohol Craving Scale(Screening (day 0), 3, 6 and 9 months)
- Obsessive Compulsive Drinking Scale(Screening (day 0), 3, 6 and 9 months)
- Assessment of MDMA/Ecstasy use following MDMA-assisted therapy(Screening (day 0), session 10, 3, 6 and 9 months)