A Phase 1 interventional study of MDMA and Psychotherapy in Alcohol Use Disorder, sponsored by Imperial College London. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-11-12.
Sponsored by Imperial College London · Phase 1, Interventional, and Treatment
The Safety, Tolerability and Role of MDMA-Assisted Psychotherapy for the treatment of detoxified patients with Alcohol Use Disorder.
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.
1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's planned enrollment of 20 is below the median of 87 across 1,371 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →Imperial College London is the lead sponsor of 824 studies on the registry; 178 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
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Be able to identify in advance a supportive significant other(s):
Exclusion Criteria
Relevant abnormal clinical findings at screening visit judged by the investigator to render subject unsuitable for study. Including but not limited to:
For females of childbearing age/potential
For males with partners of childbearing age/potential
All participants receive 2 sessions of MDMA-assisted psychotherapy
Drug: MDMA · Other: Psychotherapy
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
Two sessions of MDMA-assisted psychotherapy will take place (session 3 \& 7) within the 10 week course of psychotherapy.
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.
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).
Intensity of MDMA drug effect during MDMA-assisted psychotherapy sessions
Intensity of drug effect assessed by verbal analogue scale 0 (none) 10 (most intense drug effect), participant and observer scores recorded.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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: Diastolic Blood pressure
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.
Time frame: 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).
Subjective sleep following MDMA assisted psychotherapy
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.
Time frame: Daily for 7 days following both MDMA-assisted psychotherapy sessions (session 3 and 7).
Mood rating during 7 days following MDMA assisted psychotherapy
Profile of Mood States questionnaire (POMS), a measure of mood states, 40 self-reported items, on a 5 point scale.
Time frame: Daily for 7 days following both MDMA-assisted psychotherapy sessions (session 3 and 7).
Acceptability of MDMA-Assisted therapy program: questionnaire
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.
Time frame: 2 months , completed at psychotherapy therapy sessions (1,2,3,4,5,6,7,8,9 & 10)
Change in Drinking behaviour
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.
Time frame: 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 Quality of Life: SF-36
The Short Form Health Survey (SF-36). Gold standard, patient reported, quality of life questionnaire. Scores at follow-up visits, compared to screening/baseline.
Time frame: Screening (day 0), 3, 6 and 9 months
Change in Subjective Sleep Quality: PSQI
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.
Time frame: Screening (day 0), 3, 6 and 9 months
Change in psychosocial functioning: Short Inventory of Problems for Alcohol (SIP)
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.
Time frame: Screening (day 0), 3, 6 and 9 months
Change in psychosocial functioning: Generalized Anxiety Disorder 7 (GAD-7)
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.
Time frame: Screening (day 0), 3, 6 and 9 months
Change in psychosocial functioning: The Patient Health Questionnaire (PHQ-9)
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.
Time frame: Screening (day 0), 3, 6 and 9 months
Change in psychosocial functioning: Interpersonal reactivity Index (IRI)
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.
Time frame: Baseline, 3, 6 and 9 months
Change in psychosocial functioning: The self compassion scale (SCS)
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.
Time frame: Baseline, psychotherapy session 10 (final psychotherapy session), follow-up visits at 3, 6 and 9 months
The Penn Alcohol Craving Scale
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.
Time frame: Screening (day 0), 3, 6 and 9 months
Obsessive Compulsive Drinking Scale
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
Time frame: Screening (day 0), 3, 6 and 9 months
Prescribed medication use
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.
Time frame: Screening (day 0), 3, 6 and 9 months
Assessment of MDMA/Ecstasy use following MDMA-assisted therapy
Participants will be asked to record any recreational MDMA use or craving to use recreational MDMA outside of the study.
Time frame: Screening (day 0), session 10, 3, 6 and 9 months
Assessment of ability to collect follow-up data
Attrition at follow-up. Number of drop-outs at each visit.
Time frame: Follow up 3,6 and 9 months
Trauma History Questionnaire (THQ)
A self-report measure examining potentially traumatic experiences using a yes/no format. Administered on one occasion at the final therapy session (session 10)
Time frame: 2 month (Session 10)
Plan to share: No
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Imperial College London