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MDMA-assisted and Cognitive-Behavioral Conjoint Therapy (CBCT) in Dyads With One Member With Chronic PTSD

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02876172
First Posted: August 23, 2016
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Multidisciplinary Association for Psychedelic Studies
  Purpose
This small study will look at the safety and estimate the strength of effect (effect size) of a combination of Cognitive Behavioral Conjoint Therapy (CBCT) and 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in ten pairs of people, one with and one without PTSD. The pairs can be spouses or romantic partners, siblings or other relatives or close friends. The study will measure PTSD symptoms, as well as symptoms of depression, sleep quality and relationship satisfaction and functioning before and after a one-month course of CBCT that includes two MDMA+CBCT visits. CBCT psychotherapy is designed to treat PTSD and relationship problems in pairs in a close relationship, and MDMA-assisted psychotherapy uses the experimental drug MDMA to enhance and strengthen psychotherapy. There is evidence that each of these treatments, on its own, can help people with PTSD. The study will also measure personality and how each member of a pair thinks about and behaves in relationships and expresses emotions before and after having MDMA+CBCT. Pairs will have two day-long sessions scheduled two weeks apart. During the first MDMA+CBCT session, both members of the pair will receive 75 mg MDMA with the option of receiving a second dose of 37.5 approximately an hour and a half later. During the second session of MDMA+CBCT, subjects may receive either 100 or 75 mg, with the decision concerning dose made by the researchers after discussion with the subjects. An optional dose half the size of the initial dose will be offered approximately an hour and a half later. Following informed consent and screening there will be one enrollment visit over videoconference. Before the first MDMA+CBCT session, there will be an introductory session including 3 segments of CBCT psychotherapy on the day before the first MDMA session. The introductory session and the CBCT sessions will be done in person at the study site. During each MDMA+CBCT sessions, two therapists will work with with the pair. Blood pressure, heart rate and body temperature will be measured periodically during each MDMA+CBCT session. The pair will stay at the study site overnight with a night attendant on duty, and they will have an integrative psychotherapy session on the morning after the MDMA+CBCT session. Each member of the pair will be contacted by the researchers for a week after each MDMA+CBCT session. The pair will have CBCT and integrative sessions over videoconferencing twice a week for two weeks following the on-site integrative session. One month after the second MDMA+CBCT session, both participants will have an evaluation and testing visit over videoconference and will complete measures of PTSD symptoms, sleep quality, perceived growth related to experiencing a trauma, symptoms of depression, and how people think and feel about emotions and their relationships. The member of the pair with PTSD will also undergo an interview measure of PTSD symptoms. The pair will complete measures and questionnaires three and six months after the second MDMA+CBCT session. The study is open label, meaning the researchers and subjects will be aware of the doses of MDMA used in the study. The study will test and compare changes in symptoms and relationship issues before and after the course of psychotherapy.

Condition Intervention Phase
Posttraumatic Stress Disorder Drug: MDMA Behavioral: CBCT Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1/2 Open-Label Treatment Development Study of MDMA-Assisted Cognitive-Behavioral Conjoint Therapy (CBCT) in Dyads in Which 1 Member Has Chronic Posttraumatic Stress Disorder (PTSD)

Resource links provided by NLM:


Further study details as provided by Multidisciplinary Association for Psychedelic Studies:

Primary Outcome Measures:
  • Clinician-Administered PTSD Scale - 5 [ Time Frame: Eight weeks after enrollment ]
    Global severity scores on the CAPS-5, a measure of PTSD symptoms


Enrollment: 12
Study Start Date: October 2016
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MDMA and CBCT
Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted psychotherapy.
Drug: MDMA
Two sessions of MDMA-assisted psychotherapy, one with an initial dose of 75 mg and the second with 100 mg MDMA given to a person with PTSD and a significant other without PTSD.
Other Name: Methylenedioxymethamphetmaine
Behavioral: CBCT
A three-phase, 15-session, manualized treatment engaging an individual with PTSD and a "concerned significant other
Other Name: Cognitive behavioral conjoint therapy

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All inclusion criteria for the PTSD and CSO are identical except for first two items, marked below:
  • PTSD+ participant: Meet DSM-5 criteria for current PTSD and satisfies PTSD criteria via CAPS
  • CSO participant: Meet criteria for V62.89 Other Problem Related to Psychosocial Circumstances under Diagnostic and Statistical Manual 5 (DSM-5), as determined through clinical interview, for current psychosocial circumstances contributing to relationship distress with intimate or non-intimate partner
  • Are at least 18 years old
  • If in psychotherapy, willing and able to maintain that schedule without changing it
  • Are willing to refrain from taking any psychiatric medications during the study period, with the exception of gabapentin when prescribed for pain control.
  • Willing to remain overnight at the study site
  • Are willing to be driven home the morning after the experimental sessions, after the integrative therapy session
  • Are willing to commit to medication dosing, experimental sessions, follow-up sessions, to complete evaluation instruments and commit to be contacted for all necessary telephone contacts
  • Are willing to remain overnight at the study site after each experimental session until after the integrative session occurring the next morning
  • Must have a negative pregnancy test at study entry and prior to each experimental session if able to bear children, and must agree to use adequate birth control through 10 days after the last dose of MDMA.
  • Must provide a contact (relative, spouse, close friend or other caregiver other than the CSO participant) who is willing and able to be reached by the Clinical Investigators in the event of a participant becoming suicidal.
  • Must agree to inform the Clinical Investigators within 48 hours of any medical conditions and procedures
  • Are proficient in speaking and reading English
  • Agree to have all clinic visit and Integrative Sessions recorded to audio and video
  • Agree to not participate in any other interventional clinical trials during the duration of this study

Exclusion Criteria:

  • The following exclusions are identical for PTSD+ and CSO participants except for the following, marked below:
  • CSO participant only: Have diagnosis of current PTSD not in remission
  • Are pregnant or nursing, or are women of child bearing potential who are not practicing an effective means of birth control
  • Have evidence or history of significant medical disorders
  • Have hypertension
  • Have liver disease; asymptomatic participants with Hepatitis C who have previously undergone evaluation and successful treatment is permitted.
  • History of hyponatremia or hyperthermia
  • Weigh less than 48 kg
  • Are abusing illegal drugs
  • Are not able to give adequate informed consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02876172


Locations
United States, South Carolina
Offices of Michael Mithoefer MD
Mount Pleasant, South Carolina, United States, 29464
Sponsors and Collaborators
Multidisciplinary Association for Psychedelic Studies
Investigators
Principal Investigator: Michael C Mithoefer, MD Multidisciplinary Association for Psychedelic Studies
  More Information

Responsible Party: Multidisciplinary Association for Psychedelic Studies
ClinicalTrials.gov Identifier: NCT02876172     History of Changes
Other Study ID Numbers: MPVA-1
First Submitted: August 16, 2016
First Posted: August 23, 2016
Last Update Posted: November 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We plan to share outcome measure data upon request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: After study data lock

Keywords provided by Multidisciplinary Association for Psychedelic Studies:
PTSD
psychotherapy
MDMA
dyad
cognitive behavioral therapy

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
N-Methyl-3,4-methylenedioxyamphetamine
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Adrenergic Agents