Status:
COMPLETED
Dose-Response Study of MDMA-assisted Psychotherapy in People With PTSD
Lead Sponsor:
Lykos Therapeutics
Conditions:
Posttraumatic Stress Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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: * Do...
Detailed Description
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 13 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2017
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01793610
Start Date
May 13 2013
End Date
February 1 2017
Last Update
June 5 2025
Active Locations (1)
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1
Offices of Marcela d'Otalora
Boulder, Colorado, United States, 80304