Status:
COMPLETED
Additional MDMA-assisted Therapy for People Who Relapsed After MDMA-assisted Therapy Trial
Lead Sponsor:
Lykos Therapeutics
Conditions:
Posttraumatic Stress Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will consist of a single session of MDMA-assisted therapy with a full dose of MDMA for people who took part in a study of MDMA-assisted therapy in people with posttraumatic stress disorder ...
Detailed Description
This study will investigate the effects of an additional 3,4-methylenedioxymethamine (MDMA)-assisted therapy session in up to three participants with PTSD who relapsed after their PTSD symptoms had si...
Eligibility Criteria
Inclusion
- Be diagnosed with chronic PTSD;
- Have a CAPS score showing moderate to severe PTSD symptoms;
- Have participated in MP-1;
- 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;
- 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 :
December 15 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2014
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01458327
Start Date
December 15 2010
End Date
June 27 2014
Last Update
January 24 2024
Active Locations (1)
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1
Offices of Michael Mithoefer
Mt. Pleasant, South Carolina, United States, 29464