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
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Safety and tolerability as measured by adverse event
研究概览
简要总结
The Safety, Tolerability and Role of MDMA-Assisted Psychotherapy for the treatment of detoxified patients with Alcohol Use Disorder.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
MDMA assisted Psychotherapy
All participants receive 2 sessions of MDMA-assisted psychotherapy
干预措施: MDMA (Drug)
MDMA assisted Psychotherapy
All participants receive 2 sessions of MDMA-assisted psychotherapy
干预措施: Psychotherapy (Other)
结局指标
主要结局
Safety and tolerability as measured by adverse event
时间窗: 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.
次要结局
- 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)