Dose-Response Study of MDMA-assisted Psychotherapy in People With PTSD
Randomised, double-blind, Phase II dose-response study (n=29) comparing MDMA-assisted psychotherapy at 100 mg and 125 mg versus a 40 mg comparator in adults with chronic, treatment-resistant PTSD; three preparatory sessions, two experimental dosing sessions (up to 8 hours) with optional supplemental half-dose, and integration sessions.
Detailed Description
Randomised, triple-masked, parallel-group Phase II dose-response trial testing two active doses of oral MDMA (100 mg, 125 mg) versus a comparator dose (40 mg) given across two experimental therapy sessions in adults with chronic PTSD.
Participants received three preparatory psychotherapy sessions, two dosing sessions 3–5 weeks apart (each up to eight hours with an optional supplemental half-dose 1.5–2.5 hours after the initial dose), and three integrative sessions after each experimental session; primary endpoint assessed one month after the second experimental session.
Outcomes included change in PTSD symptom severity (CAPS), safety and tolerability measures; participants who received 40 mg could opt into an open-label stage for additional MDMA-assisted sessions.
Study Protocol
Preparation
Dosing
Integration
Therapeutic Protocol
Study Arms & Interventions
MDMA 40 mg
active comparatorComparator MDMA-assisted therapy (40 mg) across two experimental sessions; optional supplemental half-dose 1.5–2.5 h after initial dose.
Interventions
- MDMA40 mgvia Oral• two sessions• 2 doses total
Optional supplemental half-dose (20 mg) 1.5–2.5 h after initial dose.
- Compoundvia Other• throughout
Manualized psychotherapy (3 preparatory sessions, integration sessions after each experimental session).
MDMA 100 mg
experimentalActive MDMA-assisted therapy (100 mg) across two experimental sessions; optional supplemental half-dose 1.5–2.5 h after initial dose.
Interventions
- MDMA100 mgvia Oral• two sessions• 2 doses total
Optional supplemental half-dose (50 mg) 1.5–2.5 h after initial dose.
- Compoundvia Other• throughout
Manualized psychotherapy (3 preparatory sessions, integration sessions after each experimental session).
MDMA 125 mg
experimentalActive MDMA-assisted therapy (125 mg) across two experimental sessions; optional supplemental half-dose 1.5–2.5 h after initial dose.
Interventions
- MDMA125 mgvia Oral• two sessions• 2 doses total
Optional supplemental half-dose (62.5 mg) 1.5–2.5 h after initial dose.
- Compoundvia Other• throughout
Manualized psychotherapy (3 preparatory sessions, integration sessions after each experimental session).
Participants
Inclusion Criteria
- Inclusion Criteria:
- Diagnosed with chronic PTSD for six months or longer.
- Have a CAPS score showing moderate to severe PTSD symptoms.
- At least one unsuccessful attempt at treatment for PTSD either with talk therapy or with drugs, or discontinuing treatment because of inability to tolerate psychotherapy or drug therapy.
- Are at least 18 years old.
- Must be generally healthy.
- Are willing to refrain from taking any psychiatric medications during the study period.
- Willing to follow restrictions and guidelines concerning consumption of food, beverages or nicotine the night before and just prior to each MDMA session.
- Willing to remain overnight at the study site.
- Are willing to be driven home after experimental sessions either by a driver they arrange, a taxi, or study personnel.
- Are willing to be contacted via telephone by study personnel.
- If of child-bearing age, must have a negative pregnancy and agree to use an effective form of birth control.
- Must provide a personal contact who is willing to be reached in case of emergency.
- Agree to let the investigators know within 48 hours of any planned medical interventions.
- Are proficient in reading and speaking English.
- Agree to have all psychotherapy sessions recorded.
- Agree not to participate in any other interventional clinical trials during the course of the study.
Exclusion Criteria
- Exclusion Criteria:
- Are pregnant or nursing, or if of child-bearing age and do not use an effective means of birth control.
- Weigh less than 48 kg.
- Meet DSM-IV criteria for substance abuse or dependence for any substance in the past 60 days.
- Have used "Ecstasy" (material represented as containing MDMA) more than five times in the last ten years or at least once within 6 months of the MDMA session.
- Are unable to give adequate informed consent.
- Upon review of past and 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.
Study Details
- StatusCompleted
- PhasePhase II
- Typeinterventional
- DesignRandomizedtriple Blind
- Target Enrollment29 participants
- TimelineStart: 2012-10-01End: 2017-02-01
- Compounds
- Topic