Status:
COMPLETED
MDMA-Assisted Psychotherapy in People With Posttraumatic Stress Disorder
Lead Sponsor:
Lykos Therapeutics
Conditions:
Posttraumatic Stress Disorder
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The goal of this clinical trial is to compare MDMA-assisted therapy to placebo with therapy in people with chronic, treatment-resistant posttraumatic stress disorder (PTSD). The main question it aims ...
Detailed Description
This randomized, double-blind placebo-controlled pilot study assessed the safety and effectiveness of MDMA-assisted therapy among people with chronic, treatment-resistant PTSD, including veterans. Par...
Eligibility Criteria
Inclusion
- Have current PTSD (within the past 6 months) in response to crime victimization, including childhood sexual or physical abuse, or meet criteria for PTSD in response to combat;
- Have a CAPS score showing moderate to severe PTSD symptoms;
- They must either:
- Have had at least one unsuccessful attempt at treatment for PTSD with a SSRI and psychotherapy;
- Be a veteran with PTSD symptoms that have endured for no less than one year but no more than five years
- Be at least 18 years old;
- Must be generally healthy;
- Willing to remain overnight at the study site;
- Agree to have transportation home the morning after experimental sessions;
- 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;
- Are proficient in reading English;
Exclusion
- Are pregnant or nursing, or are able to bear children and are not practicing an effective means of birth control;
- Weigh less than 50 kg or more than 105 kg;
- Are unable to give adequate informed consent;
- Prior use of "Ecstasy" (illicit drug preparations purported to contain MDMA) more than 5 times or at any time within the previous 6 months;
- Have a history of certain excluded medical disorders.
Key Trial Info
Start Date :
March 12 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2010
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00090064
Start Date
March 12 2004
End Date
June 21 2010
Last Update
June 6 2025
Active Locations (1)
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1
Offices of Michael Mithoefer MD
Mt. Pleasant, South Carolina, United States, 29464