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

Launched by LYKOS THERAPEUTICS · Feb 14, 2013

Keywords

ClinConnect Summary

This Phase 2 pilot study is a randomized, double-blind, dose response study to examine the safety and efficacy of MDMA-assisted psychotherapy in 23 subjects with chronic, treatment-resistant PTSD of at least six months duration. This study assessed two active doses of MDMA, active dose 1 (100 mg) and active dose 2 (125 mg), to a comparator dose of MDMA (40 mg) during psychotherapy sessions. The initial dose of MDMA was followed 1.5 to 2.5 hours later by an optional supplemental dose of MDMA that was half the size of the first dose. MDMA was administered orally in two experimental sessions l...

Gender

ALL

Eligibility 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:
• • 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.