CompletedPhase 2

Dose-Response Study of MDMA-assisted Psychotherapy in People With PTSD

United States29 participantsStarted 2013-05-13

Plain-language summary

The goal of this clinical trial is to learn if MDMA in combination with therapy is safe and effective in people with chronic, treatment-resistant PTSD. The main questions it aims to answer are: * Does MDMA-assisted therapy reduce PTSD symptoms? * Is there a difference in PTSD symptoms between the 40 mg, 100 mg, and 125 mg groups? Researchers will compare two active doses (100 mg and 125 mg) of MDMA-assisted therapy versus a comparator dose of 40 mg MDMA-assisted therapy to determine if there is a reduction in PTSD symptoms. Participants will undergo three non-drug preparatory sessions, three MDMA-assisted therapy sessions and three non-drug integrative therapy sessions after each MDMA-assisted therapy session.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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: * Are pregnant or nursing, or if of child-bearing age and do not use an effective means of birth control. * Weigh less…

What they're measuring

Change in Clinician Administered PTSD Scale for DSM-IV (CAPS-IV) Total Severity Score From Baseline to One Month Post 2nd Experimental Session

Timeframe: Baseline Enrollment to 1-Month Post 2nd Experimental Session (Stage 1 Primary Endpoint)

Trial details

NCT IDNCT01793610

SponsorResilient Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-12-03

Results submitted2020-06-29