Clinical TrialPTSDMDMACompleted

Exploring Mechanisms of Action in MDMA-assisted Psychotherapy for PTSD

This study measures biological and psychological processes that might help researchers to better understand what is taking place during low or medium dose and full dose MDMA-assisted psychotherapy treatment in people with PTSD.

Target Enrollment
10 participants
Study Type
Phase NA observational
Design
Non-randomized

Detailed Description

This observational sub-study examines how MDMA-assisted psychotherapy affects brain and body function in people with chronic PTSD, focusing on associations between symptom change and physiological/brain measures.

Conducted in collaboration with MUSC, Smith College and the New School for Social Research, participants are drawn from the parent MP-8 trial and receive manualized MDMA-assisted psychotherapy.

Measures include fMRI (neutral and personalised trauma scripts), diffusion tensor imaging (DTI), and heart rate monitoring for HRV; scans/measurements occur at baseline and at specified post-treatment intervals depending on dose condition.

Psychotherapeutic processes are assessed via observation and coding of therapy sessions and self-report measures (eg, Self-Compassion Scale).

Study Protocol

Preparation

sessions

Dosing

sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

MDMA-assisted therapy

experimental

Participants from the parent MP-8 trial undergoing manualized MDMA-assisted psychotherapy

Interventions

  • MDMA
    via Oral• per session

    30, 75, or 125 mg oral MDMA followed 1.5–2 h later by a supplemental half-dose (dose condition per parent trial).

  • Compound
    via Other

    Manualized psychotherapy (behavioral)

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Enrolled in the parent study, "A Randomized, Triple-Blind, Phase 2 Pilot Study Comparing 3 Different Doses of MDMA in Conjunction with Manualized Psychotherapy in 24 Veterans, Firefighters, and Police Officers with Chronic, Treatment-Resistant Posttraumatic Stress Disorder (PTSD)." NCT #: NCT01211405
  • Participants from the MP-8 study invited to enroll in this sub-study (undergo fMRI and other physiological measurements).

Exclusion Criteria

  • Exclusion Criteria:
  • Mass brain lesion
  • Metal in skull
  • Brain or heart pacemaker
  • History of major head trauma
  • Past or present panic or extreme discomfort with being in small enclosed spaces (claustrophobia)

Study Details

  • Status
    Completed
  • Phase
    Phase NA
  • Type
    observational
  • Design
    Non-randomized
  • Target Enrollment10 participants
  • Timeline
    Start: 2014-01-01
    End: 2017-01-04
  • Compound
    MDMA
  • Topic
    PTSD

Locations

Offices of Michael Mithoefer — Mt. Pleasant, South Carolina, United States

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