MDMA-Assisted Psychotherapy in People With Posttraumatic Stress Disorder
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this clinical trial is to compare MDMA-assisted therapy to placebo with therapy
      in people with chronic, treatment-resistant posttraumatic stress disorder (PTSD). The main
      question it aims to answer is: Is there a reduction in PTSD symptoms among people given
      MDMA-assisted therapy compared to placebo with therapy?

      Participants will receive either MDMA-assisted therapy or placebo with therapy during two
      blinded experimental sessions spaced three to five weeks apart. During experimental sessions,
      participants receive an initial dose of 125 mg of MDMA, or placebo, followed by a dose of
      62.5 mg of MDMA, or placebo. During this treatment period, participants will also undergo
      non-drug preparatory psychotherapy sessions and non-drug integrative sessions.

      The study will test whether MDMA-assisted therapy can be safely given to participants.
      Researchers will compare PTSD symptoms in the MDMA-assisted therapy group to the placebo with
      therapy group to see if there is a reduction in symptoms after the treatment period.
    

Detailed description: 
      Posttraumatic stress disorder (PTSD) occurs in response to a traumatic event or events. PTSD
      is a public health problem that causes a great deal of suffering and accounts for a
      significant portion of health care costs.

      MDMA is a substance possessing unique effects that make it well suited to intensive
      psychotherapy. MDMA has been hypothesized to represent a new class of drugs, called
      entactogens, that produce feelings of closeness to others, empathy, well being, and
      insightfulness. Anecdotal reports of therapy conducted before MDMA was placed on Schedule I
      suggest that MDMA-assisted therapy may benefit people with PTSD.

      This randomized, double-blind placebo-controlled pilot study assessed the safety and
      effectiveness of MDMA-assisted therapy among people with chronic, treatment-resistant PTSD,
      including veterans. Participants were assigned to receive either MDMA-assisted therapy or
      placebo with therapy during two blinded experimental sessions spaced three to five weeks
      apart during Stage 1 of the study. During these experimental sessions, participants received
      an initial dose of 125 mg of MDMA followed by a supplemental dose of 62.5 mg of MDMA, or they
      received initial and supplemental doses of inactive placebo. Psychotherapists and independent
      raters were blinded to participants' treatment conditions. This treatment period also
      consisted of non-drug preparatory therapy sessions and non-drug integration therapy sessions.

      During Stage 2 of the study, the blind was broken and participants assigned to receive
      MDMA-assisted therapy in Stage 1 underwent a third open-label experimental session of
      MDMA-assisted therapy. Participants assigned placebo with therapy during Stage 1 who chose to
      enroll in Stage 2 underwent three open-label sessions of MDMA-assisted therapy. Outcome
      measures were administered two months after the second experimental session in Stage 1 and
      four to six weeks after the second MDMA-assisted therapy session in Stage 2. A final
      data-collection session took place at two months after the third experimental session.

      The primary objective of the study was to measure change in PTSD symptoms via CAPS-IV across
      the study in participants receiving MDMA-assisted therapy versus placebo with therapy.
    

Intervention name(s): Midomafetamine; Lactose placebo pill; Therapy
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): 125 mg followed by a supplemental half-dose of 62.5 mg; 125 mg followed by a supplemental half-dose of 62.5 mg; Non-directive therapy provided by a team of two co-therapists
Other intervention name(s): MDMA; 3,4-methylenedioxymethamphetamine; Placebo
Intervention MeSH terms: N-Methyl-3,4-methylenedioxyamphetamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MDMA; Methylenedioxymethamphetamine; PTSD; psychotherapy