CompletedPhase 2MDMA
Additional MDMA-assisted Therapy for People Who Relapsed After MDMA-assisted Therapy Trial
Sponsored by Lykos Therapeutics
NCT ID
NCT01458327
Target Enrollment
3 participants
Start Date
2010-12-15
Est. Completion
2014-06-27
About This Study
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 (PTSD) whose PTSD symptoms returned to higher levels at least a year after the first MDMA sessions. The single session will be performed by the same pair of therapists who performed the sessions in the first study. People will have a preparatory session, the MDMA-assisted session and three non-drug sessions afterward. Their PTSD symptoms and symptoms of depression will be measured at the start of this study and two and 12 months after the session.
Conditions Studied
Interventions
- •Midomafetamine
- •Therapy
Eligibility
Age:18 Years - N/A
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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.
Study Locations (1)
Offices of Michael Mithoefer
Mt. Pleasant, South Carolina, United States