A. Specific Aims

Posttraumatic stress disorder (PTSD) is a serious and debilitating mental illness resulting from experiencing one or more traumatic events, such as physical or sexual assault or participating in active combat. There is a need for an array of possible treatments for this condition. Treatment of this psychiatric disorder is currently limited to a few pharmacological and psychotherapeutic treatments (Bradley et al. 2005), and a significant number of people do not find these treatments sufficiently helpful (Hamner et al. 2004). Drawing on evidence from anecdotal reports and controlled and uncontrolled research studies, the investigators hypothesize that 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy may alleviate symptoms and improve quality of life for people with PTSD, including people who have not responded well to accepted pharmacological or psychotherapeutic treatments for this condition. If findings from a pilot study of MDMA-assisted psychotherapy in 20 people with treatment-resistant PTSD under way in South Carolina are promising, then additional Phase II and Phase III studies are planned to test the efficacy of MDMA-assisted therapy as a treatment for PTSD. A manual of standardized procedures for MDMA-assisted psychotherapy must be developed before these larger Phase II and Phase III studies can be conducted. The proposed project will be for the development of the first treatment manual for MDMA-assisted therapy in people with PTSD, including evaluative guidelines and measures of therapist adherence and competence. Treatment manual development and conducting larger studies are intended to lead to the development of an innovative option for treatment of PTSD that will improve quality of life in people suffering this debilitating mental illness.

The proposed project is intended to meet specific aims and goals. The aims and goals are the following:

  1. To develop a treatment manual containing standardized methods, procedures and evaluative guidelines for conducting MDMA-assisted therapy for use in conducting multi-site studies of MDMA-assisted therapy in people with posttraumatic stress disorder.
  2. To develop measures of therapist adherence and competence in performing MDMA-assisted psychotherapy as represented in the treatment manual, and to begin developing a training program for therapists who will perform MDMA-assisted psychotherapy in research studies.
In the near future, investigations of MDMA-assisted psychotherapy are planned to take place in Israel, Switzerland and Spain, and further Phase III studies will be needed to test the efficacy of MDMA-assisted psychotherapy. The investigators will use a treatment manual and a training program to teach therapist-investigators to perform this therapy in a standardized manner. Developing a treatment manual that describes and encapsulates these methods and procedures will be an essential part of performing further research into the safety and efficacy of MDMA-assisted psychotherapy in people with PTSD. This novel combination of psychotherapy and pharmacological adjunct may be especially helpful in treating people with PTSD symptoms that do not resolve after receiving currently recognized treatments for PTSD. As such, this therapy could benefit people who continue to suffer from PTSD despite receiving psychotherapy or medication. The intervention itself is unusual in its use of psychotherapy along with a drug adjunct, and its potential success may lead to further research into the potential of the use of psychotherapy adjuncts.

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