Study Comparing Three Doses of MDMA Along With Therapy in Veterans With Posttraumatic Stress Disorder

Posttraumatic Stress Disorder Clinical Trial

Official title: Randomized, Triple-Blind, Phase 2 Pilot Study Comparing 3 Different Doses of MDMA in Conjunction With Manualized Therapy in 24 Veterans, Firefighters and Police Officers With Chronic Posttraumatic Stress Disorder (PTSD)

Status Completed

Clinical Trial Summary

This study is designed to provide information on whether therapy ("talk therapy") combined with the drug MDMA is safe and helpful for subjects with posttraumatic stress disorder (PTSD). The study will compare the effects of a low, a medium and a full dose of MDMA on symptoms of PTSD in 24 veterans, firefighters or police officers. MDMA dose will be assigned at random, and the investigators and the subject will not know the dose given. The researchers will also investigate depression symptoms. The researchers believe that the full dose of MDMA will produce a greater reduction in PTSD symptoms than the two lower doses.

Clinical Trial Description

Posttraumatic stress disorder (PTSD) is a debilitating mental disorder, that can develop after service in the armed forces. Therapy performed along with MDMA is an innovative form of therapy for PTSD. This study will follow on the findings of an initial pilot study in a sample largely made up of people whose PTSD did not develop from serving in the military. This study will investigate whether MDMA-assisted therapy is safe and efficacious in a sample of veterans and whether maintaining an effective double-blind can be better addressed by performing a dose comparison study.

This study is a randomized, double-blind, dose comparison study with an open-label cross-over segment that will assess the safety and efficacy of MDMA-assisted therapy in veterans with chronic PTSD. Twelve of 24 participants will receive the full dose of 125 mg, six will receive 75 mg and six will receive 30 mg (active placebo dose). An independent rater blind to condition will assess symptoms of PTSD and depression, general quality of life and posttraumatic growth prior to any therapy sessions one month after the second experimental session.

After undergoing three 90-minute non-drug introductory therapy sessions with a male/female co-therapist team, study participants will undergo two eight-hour long experimental sessions scheduled three to five weeks apart, during which they will randomly receive either 30, 75 or 125 mg MDMA on both occasions, followed by a supplemental dose of half the initial dose. Participants will undergo integrative therapy in between each experimental session, including on the day after each session. Vital signs and psychological distress will be measured throughout each experimental session, and suicidality will be assessed throughout the course of the study. Spontaneously reported side effects will be collected on the day of each experimental session, and for six days afterward. PTSD symptoms, symptoms of depression, general psychological function, posttraumatic growth and quality of sleep will be assessed one month after the second experimental session, and the blind will be broken.

Participants who received 125 mg MDMA will continue to have a third experimental session, and they will be assessed two months after the third experimental session.

Participants who received 30 or 75 mg MDMA may take part in an open-label crossover segment that will follow nearly identical procedures, except that there will only be one introductory session prior to the first experimental session. There will be three experimental sessions. Symptoms of PTSD, depression and posttraumatic growth will be assessed at the start of the study. They will also be assessed one month after the second and two months after the third experimental session.

All participants will be assessed 12 months after their final experimental session. PTSD and depression symptoms and posttraumatic growth will be assessed, and participants will complete a questionnaire concerning the costs and benefits of being in the study. ;

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

• NCT number: NCT01211405
• Study type: Interventional
• Source: Lykos Therapeutics
• Status: Completed
• Phase: Phase 2
• Start date: November 10, 2010
• Completion date: August 2, 2016