Status:
COMPLETED
Study Comparing Three Doses of MDMA Along With Therapy in Veterans With Posttraumatic Stress Disorder
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-assisted therapy is safe and effective and reducing PTSD symptoms in veterans with chronic PTSD. The main question it aims to answer is: Do three do...
Detailed Description
This study is a randomized, double-blind, dose comparison study with an open-label cross-over segment that will assess the safety and efficacy of MDMA-assisted therapy in veterans with chronic PTSD. T...
Eligibility Criteria
Inclusion
- Be diagnosed with chronic PTSD, duration of 6 months or longer resulting from traumatic experience during military service;
- Have a CAPS score showing moderate to severe PTSD symptoms;
- Have had 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;
- Must sign a medical release for the investigators to communicate directly with their therapist and doctors;
- Are willing to refrain from taking any psychiatric medications during the study period;
- Willing to follow restrictions and guidelines concerning consumption of food, beverages, and nicotine the night before and just prior to each experimental session;
- Willing to remain overnight at the study site;
- Agree to have transportation other than driving themselves home or to where they are staying after the integrative session on the day after the MDMA session;
- Are willing to be contacted via telephone for all necessary telephone contacts;
- Must have a negative pregnancy test if able to bear children, and agree to use an effective form of birth control;
- Must provide a contact in the event of a participant becoming suicidal;
- Are proficient in speaking and reading English;
- Agree to have all clinic visit sessions recorded to audio and video
- Agree not to participate in any other interventional clinical trials during the duration of this study.
Exclusion
- 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;
- Have used ecstasy (material representing itself as MDMA) more than 5 times or at least once in the last 6 months;
- 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.
Key Trial Info
Start Date :
November 10 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 2 2016
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01211405
Start Date
November 10 2010
End Date
August 2 2016
Last Update
June 5 2025
Active Locations (1)
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1
Offices of Michael Mithoefer
Mt. Pleasant, South Carolina, United States, 29464-4345