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MDMA-Assisted Cognitive-Behavioral Conjoint Therapy (CBCT) in Dyads in Which 1 Member Has Chronic PTSD

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ClinicalTrials.gov Identifier: NCT02876172
Recruitment Status : Completed
First Posted : August 23, 2016
Last Update Posted : April 22, 2021
Sponsor:
Information provided by (Responsible Party):
Multidisciplinary Association for Psychedelic Studies

Tracking Information
First Submitted Date  ICMJE August 16, 2016
First Posted Date  ICMJE August 23, 2016
Last Update Posted Date April 22, 2021
Study Start Date  ICMJE October 2016
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2021)
Change From Baseline to Primary Endpoint in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score [ Time Frame: Baseline (screening) to Primary Endpoint (Visit 16, approximately 2 months later) ]
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 total severity score, and a diagnostic score. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
Original Primary Outcome Measures  ICMJE
 (submitted: August 18, 2016)
Clinician-Administered PTSD Scale - 5 [ Time Frame: Eight weeks after enrollment ]
Global severity scores on the CAPS-5, a measure of PTSD symptoms
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2021)
  • Change From Baseline to Long-term Follow-up at 3 Months in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score [ Time Frame: Baseline (screening) to Follow-up (3 months post-study) ]
    The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 total severity score, and a diagnostic score. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
  • Change From Baseline to Long-term Follow-up at 6 Months in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score [ Time Frame: Baseline (screening) to Follow-up (6 months post-study) ]
    The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 total severity score, and a diagnostic score. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MDMA-Assisted Cognitive-Behavioral Conjoint Therapy (CBCT) in Dyads in Which 1 Member Has Chronic PTSD
Official Title  ICMJE A 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)
Brief Summary This Phase 1/2 open-label study will combine methods for conducting MDMA-assisted psychotherapy with methods from the CBCT for PTSD in order to treat 10 participants with chronic PTSD and their partners (intimate or non-intimate significant other who does not have a current diagnosis of PTSD) in order to explore whether combined treatment is effective. Each therapy team will have one therapist trained and experienced in MDMA assisted psychotherapy and one therapist trained and experienced in CBCT. During the first experimental session, both participants will receive 75 mg of MDMA followed 1.5 to 2 hours later by an optional supplemental half-dose of 37.5 mg. During the second experimental session, an initial dose of either 100 or 75 mg of MDMA will be administered to both participants followed by an optional supplemental half-dose of either 50 mg or 37.5 mg. The primary objective of this study is to assess changes in PTSD symptoms from Baseline to Primary Endpoint in CAPS-5 total severity scores in PTSD participants.
Detailed Description

PTSD is a stress-related psychiatric condition that may occur following a traumatic event such as war, disaster, sexual abuse, violence, terrorism, and accidents. PTSD negatively impacts a person's daily life, resulting in relationship difficulties, difficulty in finding and maintaining a job, reduced cognitive and psychosocial functioning, substance abuse, high-cost healthcare use, and increased depression and suicide risk.

3,4-methylenedioxymethamphetamine is a drug that releases serotonin, norepinephrine and dopamine in the brain and indirectly increases levels of the neurohormones oxytocin, arginine vasopressin and cortisol. In the context of psychotherapy, MDMA has been noted to reduce defenses and fear of emotional injury while enhancing communication and capacity for introspection.

Cognitive-Behavioral Conjoint Therapy (CBCT) for PTSD is a three-phase, 15-session, manualized treatment. This Phase 1/2 open-label study will combine methods for conducting MDMA-assisted psychotherapy with methods from the CBCT for PTSD in order to treat 10 participants with chronic PTSD and their partners (intimate or non-intimate significant other who does not have a current diagnosis of PTSD) in order to explore whether combined treatment is effective. Each therapy team will have one therapist trained and experienced in MDMA assisted psychotherapy and one therapist trained and experienced in CBCT. During the first experimental session, both participants will receive 75 mg of MDMA followed 1.5 to 2 hours later by an optional supplemental half-dose of 37.5 mg. During the second experimental session, an initial dose of either 100 or 75 mg of MDMA will be administered to both participants followed by an optional supplemental half-dose of either 50 mg or 37.5 mg. The primary objective of this study is to assess changes in PTSD symptoms from Baseline to Primary Endpoint in CAPS-5 total severity scores in PTSD participants.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Posttraumatic Stress Disorder
Intervention  ICMJE
  • Drug: MDMA
    Two sessions of MDMA-assisted psychotherapy, one with an initial dose of 75 mg (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg MDMA (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.
    Other Name: Methylenedioxymethamphetmaine
  • Behavioral: CBCT
    A three-phase, 15-session, manualized treatment from the CBCT manual
    Other Name: Cognitive behavioral conjoint therapy
  • Behavioral: Therapy
    Non-directive therapy (from MAPS MDMA-assisted therapy treatment manual)
Study Arms  ICMJE Experimental: MDMA and CBCT
Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted psychotherapy.
Interventions:
  • Drug: MDMA
  • Behavioral: CBCT
  • Behavioral: Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 16, 2017)
12
Original Estimated Enrollment  ICMJE
 (submitted: August 18, 2016)
20
Actual Study Completion Date  ICMJE July 2018
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02876172
Other Study ID Numbers  ICMJE MPVA-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: We plan to share outcome measure data upon request
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: After study data lock
Responsible Party Multidisciplinary Association for Psychedelic Studies
Study Sponsor  ICMJE Multidisciplinary Association for Psychedelic Studies
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael C Mithoefer, MD Multidisciplinary Association for Psychedelic Studies
PRS Account Multidisciplinary Association for Psychedelic Studies
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP