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

Posttraumatic Stress Disorder

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

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source

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