MDMA-Assisted Therapy for Veterans with PTSD

NOT YET OPEN FOR RECRUITMENT

A Sunstone Therapies IIT (Investigator Initiated Study)

Sunstone is recruiting veterans* for a trial evaluating the effect of a single dose of MDMA treatment along with individual versus group therapy.

Introduction and Rationale for Study

Post-traumatic stress disorder (PTSD) is a debilitating and serious health condition that impacts an individual’s relationships, cognitive and psychosocial functioning, and overall quality of life. PTSD is more common among groups at high risk for trauma exposure, such as active-duty military service members and veterans. Although numerous therapeutic approaches, including the use of antidepressant medications, exist for addressing PTSD, current treatments are insufficient.

Recent clinical trials have demonstrated significant and sustained reduction in PTSD symptoms with MDMA-assisted psychotherapy administered in an individual setting. Group psychotherapy has been shown to have benefits in PTSD treatment, including normalization of symptoms, social support, interpersonal learning, and cost-effectiveness. The combination of MDMA with group therapy may provide synergistic effects to enhance treatment outcomes.

Directly comparing MDMA-assisted individual vs. group therapy is an important first step in evaluating the safety and feasibility of this novel approach.

Purpose and Description

To evaluate the safety and tolerability of individual vs group MDMA-assisted therapy in veterans with PTSD.

Study participation will include but is not limited to the following study visits over the course of approximately 8 weeks:

  • Screening Period
  • Three (3) Preparatory Sessions
  • One (1) Dosing Session
  • Three (3) Integration Sessions
  • Up to 12 monthly group Integration Sessions after the 8 week period

Important Considerations

  • The study’s procedures and therapy are at no cost to the participant. 
  • Eligible participants will receive a single dose of MDMA. All study participants will receive active study drug. 
  • MDMA will be administered with support from specially trained and experienced mental-health practitioners in private rooms specifically designed for psychedelic therapy. Physicians and medical staff are present on site. 
  • The support includes careful preparation before the psychedelic experience and processing after the experience with a therapist in either an individual or group setting. Psychedelic effects are typically temporary, and safety is continually monitored.
  • Participants may remain on SSRIs if they have been on a stable dose for at least 3 months prior to enrollment  and do not plan to change their dosage until the end of the study. Participants MUST NOT change or discontinue ANY medication without the physician’s approval. If necessary, the study physician will consult with patients’ providers.
  • Participants should not be pregnant, nursing or planning a pregnancy, and must agree to use a highly effective method of birth control during the entire course of the clinical trial. 
  • Risks to participation will be reviewed extensively during the screening and informed consent process.
  • All in-person study visits take place at Sunstone Therapies, Rockville, Maryland.

To express interest in this upcoming study, click here:

Register Your Interest