Bristol Imperial MDMA in Alcoholism Study
- Registration Number
- NCT04158778
- Lead Sponsor
- Imperial College London
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MDMA assisted Psychotherapy Psychotherapy All participants receive 2 sessions of MDMA-assisted psychotherapy MDMA assisted Psychotherapy MDMA All participants receive 2 sessions of MDMA-assisted psychotherapy
- Primary Outcome Measures
Name Time Method Safety and tolerability as measured by adverse event 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 Outcome Measures
Name Time Method Subjective sleep following MDMA assisted psychotherapy Daily for 7 days following both MDMA-assisted psychotherapy sessions (session 3 and 7). Leeds Evaluation Questionnaire, subjective, self-report measure, assessing changes in sleep quality and early morning behaviour. Visual analogue, positive end means improvement, negative ends mean decline in sleeping.
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 Subjective Units of Distress scale (SUDS), degree of psychological (subjective) distress, rated from 0 (not at all distressed/completely relaxed) to 10 (most distressed imaginable/ panic attack). Participant and observer scores recorded.
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). The following will be measured 1 hour before dosing, at dosing, every 30 mins for 2 hours and hourly thereafter for 6 hours (extra measures taken if clinically required).
-Temperature (degrees celsius) Pre-dosing measures will be compared to those taken after dosing.Mood rating during 7 days following MDMA assisted psychotherapy Daily for 7 days following both MDMA-assisted psychotherapy sessions (session 3 and 7). Profile of Mood States questionnaire (POMS), a measure of mood states, 40 self-reported items, on a 5 point scale.
Acceptability of MDMA-Assisted therapy program: questionnaire 2 months , completed at psychotherapy therapy sessions (1,2,3,4,5,6,7,8,9 & 10) Acceptability questionnaire designed for the study, this self report measure includes visual analogue scales and free text addressing the participants acceptability of taking part in the trial.
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. Intensity of drug effect assessed by verbal analogue scale 0 (none) 10 (most intense drug effect), participant and observer scores recorded.
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). The following will be measured 1 hour before dosing, at dosing, every 30 mins for 2 hours and hourly thereafter for 6 hours (extra measures taken if clinically required).
Blood Pressure (mmHg) Pre-dosing measures will be compared to those taken after dosing.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 Drinking behaviour will be assessed using the clinician administered Time Line Follow Back scale- this tool allows collection of information about alcohol and illicit drug use. Pre-detoxification (screening visit) levels will be compared to levels at the final psychotherapy visit (session 10) and follow-up visits 3, 6 and 9 months. Any illicit drug use will also be recorded using this scale and assessed similarly.
Change in Subjective Sleep Quality: PSQI Screening (day 0), 3, 6 and 9 months The Pittsburgh Sleep Quality Index. (PSQI). Sleep report questionnaire assessing the level of sleep disturbance. Scores collected at psychotherapy session 10 (final psychotherapy session), and follow-up visits compared to screening/ baseline.
Prescribed medication use Screening (day 0), 3, 6 and 9 months Prescribed medication use will be collected at every face-to-face visit and number and type of medications at psychotherapy session 10 (final psychotherapy session), and follow-up visits compared to screening/baseline.
Assessment of ability to collect follow-up data Follow up 3,6 and 9 months Attrition at follow-up. Number of drop-outs at each visit.
Trauma History Questionnaire (THQ) 2 month (Session 10) A self-report measure examining potentially traumatic experiences using a yes/no format. Administered on one occasion at the final therapy session (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). The following will be measured 1 hour before dosing, at dosing, every 30 mins for 2 hours and hourly thereafter for 6 hours (extra measures taken if clinically required).
-Heart rate (bpm) Pre-dosing measures will be compared to those taken after dosing.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). The following will be measured 1 hour before dosing, at dosing, every 30 mins for 2 hours and hourly thereafter for 6 hours (extra measures taken if clinically required).
Blood Pressure (mmHg) Pre-dosing measures will be compared to those taken after dosing.Change in psychosocial functioning: Short Inventory of Problems for Alcohol (SIP) Screening (day 0), 3, 6 and 9 months Short Inventory of Problems for Alcohol (SIP) Scale. This is a 15-item instrument assessing the self-attributable consequences of drinking. Scores collected at psychotherapy session 10 (final psychotherapy session), and follow-up visits compared to screening/ baseline.
Change in psychosocial functioning: The Patient Health Questionnaire (PHQ-9) Screening (day 0), 3, 6 and 9 months The Patient Health Questionnaire (PHQ-9). Brief self-administered questionnaire assessing depressive symptoms.Scores collected at psychotherapy session 10 (final psychotherapy session), and follow-up visits compared to screening/ baseline.
Change in Quality of Life: SF-36 Screening (day 0), 3, 6 and 9 months The Short Form Health Survey (SF-36). Gold standard, patient reported, quality of life questionnaire. Scores at follow-up visits, compared to screening/baseline.
Change in psychosocial functioning: Generalized Anxiety Disorder 7 (GAD-7) Screening (day 0), 3, 6 and 9 months Generalized Anxiety Disorder 7 (GAD-7) scale. Brief self-administered questionnaire assessing anxiety. Scores collected at psychotherapy session 10 (final psychotherapy session), and follow-up visits compared to screening/ baseline.
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 The self compassion scale (SCS) self-administered scale assesses core aspects of self compassion including components of mindfulness. Scores collected at psychotherapy session 10 (final psychotherapy session), and follow-up visits compared to baseline.
Change in psychosocial functioning: Interpersonal reactivity Index (IRI) Baseline, 3, 6 and 9 months Interpersonal reactivity Index (IRI) self-administered scale assessing aspects of empathy Scores collected at psychotherapy session 10 (final psychotherapy session), and follow-up visits compared to baseline.
The Penn Alcohol Craving Scale Screening (day 0), 3, 6 and 9 months The Penn Alcohol Craving Scale (PACS) will assess craving, specifically frequency, intensity and duration of thoughts about drinking.Scores collected at psychotherapy session 10 (final psychotherapy session), and follow-up visits compared to baseline.
Obsessive Compulsive Drinking Scale Screening (day 0), 3, 6 and 9 months Obsessive Compulsive Drinking Scale self-rated scale, used to measure obsessive and compulsive thoughts in relation to alcohol. Scores at psychotherapy session 10 (final psychotherapy session) and follow up visits will be compared to baseline
Assessment of MDMA/Ecstasy use following MDMA-assisted therapy Screening (day 0), session 10, 3, 6 and 9 months Participants will be asked to record any recreational MDMA use or craving to use recreational MDMA outside of the study.
Trial Locations
- Locations (1)
Study Center: University of Bristol
🇬🇧Bristol, United Kingdom