A Randomized, Double-Blind, Placebo-Controlled Phase 2 Pilot Study of MDMA-Assisted Psychotherapy for Anxiety Associated With a Life-Threatening Illness
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change in State Trait Anxiety Inventory (STAI) Trait Score From Baseline to Primary Endpoint
研究概览
简要总结
The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people with anxiety associated with a life-threatening illness. The main question it aims to answer is: Does anxiety decrease in people receiving two sessions of MDMA-assisted therapy?
Researchers will compare people receiving placebo with therapy to people receiving MDMA-assisted therapy.
- Participants will undergo three non-drug preparatory therapy sessions before their first blinded session of MDMA or placebo with therapy.
- Each medication session will be followed by three non-drug integrative therapy sessions.
- After the second blinded medication session, participants receiving MDMA will complete a third open-label medication session.
- Participants who received placebo will be given the option to crossover and receive three sessions of assisted therapy.
详细描述
This Phase 2 pilot study is a randomized, double-blind, placebo-controlled study in 18 participants comparing the effects of MDMA-assisted therapy vs. placebo with therapy. Thirteen participants were randomized to the active dose condition of 125 mg of MDMA HCl (plus an optional supplemental dose of 62.5 mg MDMA HCl) with therapy and five participants were randomized to the placebo with therapy condition. The study consisted of two blinded experimental sessions of MDMA-assisted therapy or placebo with therapy, each session lasting six to eight hours and scheduled two to four weeks apart. Each participant was unblinded one month after their second experimental session in Stage 1. After unblinding, participants receiving MDMA were to complete a third open-label experimental session of MDMA-assisted therapy and participants who originally received placebo had the opportunity to cross over to open-label Stage 2 and receive active MDMA-assisted therapy in 3 sessions.
The primary objective of the study is to assess changes in trait anxiety in subjects receiving active dose MDMA compared to those receiving placebo as measured by State-Trait Anxiety Index (STAI) Trait scores from Baseline to the Primary Endpoint (one month after the second experimental session).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with life-threatening cancer or non-dementing neurological illness, which can be ongoing or in remission, but with a possibility of recurrence
- •Prognosis of at least nine months life expectancy from the time of screening
- •Have anxiety as a result of facing their illness
- •Are at least 18 years old
- •Are willing to refrain from taking any psychiatric medications during the study period;
- •Are willing to commit to medication dosing, experimental sessions, follow-up sessions, and to complete evaluation instruments
- •Are willing to remain overnight at the study site after each experimental session until after the integrative session occurring the next morning
- •Must sign a medical release for the investigators to communicate directly with their therapist and doctors;
- •Are willing to select up to three observers who will complete observer measures of subject attitudes and behavior
- •Negative pregnancy test if able to bear children and agree to use effective birth control
- •Are proficient in speaking and reading English
- •Agree to have all psychotherapy sessions recorded to audio/video.
排除标准
- •Are pregnant or nursing, or if a woman who can have children, those who are not practicing an effective means of birth control;
- •Weigh less than 48 kg
- •Are abusing illegal drugs
- •Are unable to give adequate informed consent
- •Upon review of past, current drugs/medication must not be on or have taken a medication that is exclusionary
- •Upon review of medical or psychiatric history must not have any current or past diagnosis that would be considered a risk to participation in the study
- •Have used "Ecstasy" (material represented as containing MDMA) at least once within twelve months of enrollment.
研究组 & 干预措施
Placebo with therapy
Inactive placebo administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by (optional) inactive placebo supplemental dose.
干预措施: Placebo (Drug)
Placebo with therapy
Inactive placebo administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by (optional) inactive placebo supplemental dose.
干预措施: Therapy (Behavioral)
MDMA-assisted therapy (125 mg)
125 mg midomafetamine HCl administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by a (optional) supplemental dose of 62.5 mg.
干预措施: Midomafetamine HCl (Drug)
MDMA-assisted therapy (125 mg)
125 mg midomafetamine HCl administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by a (optional) supplemental dose of 62.5 mg.
干预措施: Therapy (Behavioral)
结局指标
主要结局
Change in State Trait Anxiety Inventory (STAI) Trait Score From Baseline to Primary Endpoint
时间窗: Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session)
The State-Trait Anxiety Inventory (STAI) is a 20-item self-report measure of intensity of anxiety. Each item consists of a 4-point Likert rating scale ranging from 1 ('Not at all') to 4 ('Very Much So'), with higher scores indicating greater anxiety. Items were summed for a total score that ranged from 20 to 80. The STAI differentiates between State Anxiety, defined as "anxiety experienced in reaction to a specific environmental circumstance," and Trait Anxiety, defined as "long-standing nervous affect or anxiety disorder." The use of the trait subscale as the primary outcome measure was intended to target those anxiety symptoms that are chronic and pervasive.
Primary Endpoint STAI Trait Score
时间窗: One month post-2nd experimental session
The State-Trait Anxiety Inventory (STAI) is a 20-item self-report measure of intensity of anxiety. Each item consists of a 4-point Likert rating scale ranging from 1 ('Not at all') to 4 ('Very Much So'), with higher scores indicating greater anxiety. Items were summed for a total score that ranged from 20 to 80. The STAI differentiates between State Anxiety, defined as "anxiety experienced in reaction to a specific environmental circumstance," and Trait Anxiety, defined as "long-standing nervous affect or anxiety disorder." The use of the trait subscale as the primary outcome measure is intended to target those anxiety symptoms that are chronic and pervasive.
次要结局
- Change in STAI State Score From Baseline to Primary Endpoint(Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session))
- Change in Beck Depression Inventory-II (BDI-II) Score From Baseline to Primary Endpoint(Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session))
- Change in Death Attitudes Profile (DAP) From Baseline to Primary Endpoint(Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session))
- Change in Global Assessment of Functioning (GAF) Score From Baseline to Primary Endpoint(Baseline (3 months from enrollment) to Primary Endpoint (one month post 2nd experimental session))
- Change in MADRS Score From Baseline to Primary Endpoint(Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session))
- Change in Self-Compassion Scale (SCS) From Baseline to Primary Endpoint(Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session))
- Change in Pittsburgh Sleep Quality Inventory (PSQI) From Baseline to Primary Endpoint(Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session))
- Change in Posttraumatic Growth Inventory (PTGI) From Baseline to Primary Endpoint(Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session))
- Change in Functional Assessment of Chronic Illness Therapy Scale (FACIT) From Baseline to Primary Endpoint(Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session))