Clinical trial NCT02876172: MDMA-Assisted Cognitive-Behavioral Conjoint Therapy (CBCT) in Dyads in Which 1 Member Has Chronic PTSD
Official title: A Phase 1/2 Open-Label Treatment Development Study of Methylenedioxymethamphetamine (MDMA)-Assisted Cognitive-Behavioral Conjoint Therapy (CBCT) in Dyads in Which 1 Member Has Chronic Posttraumatic Stress Disorder (PTSD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Posttraumatic Stress Disorder
Keywords: PTSD
therapy
MDMA
dyad
cognitive behavioral therapy
Lead sponsor: Lykos Therapeutics
Sponsor class: INDUSTRY
First posted: 2016-08-23
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if cognitive-behavioral conjoint therapy (CBCT) in combination with MDMA-assisted therapy is safe and effective in people with chronic PTSD and their partners.

The main question it aims to answer is: Does MDMA-assisted CBCT reduce PTSD symptoms in people with chronic PTSD?

Participants (chronic PTSD patients and their partners) will undergo three non-drug preparatory therapy sessions, followed by two MDMA-assisted therapy sessions. Each MDMA-assisted therapy session will be followed by five non-drug integrative therapy using CBCT.

Detailed description: 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 therapy 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 therapy and one therapist trained and experienced in CBCT. During the first experimental session, both participants will receive 75 mg of midomafetamine HCl 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 midomafetamine HCl 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 Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total severity scores in PTSD participants.

Eligibility criteria: Inclusion Criteria:

* All inclusion criteria for the PTSD and Concerned Significant Other (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
* Have used "Ecstasy" (material represented as containing MDMA) more than 10 times within the last 10 years or at least once within 6 months of the MDMA-assisted session
* Are not able to give adequate informed consent

Primary outcomes:
measure: Primary Endpoint Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score
timeFrame: Primary Endpoint (Visit 16, approximately 2 months later)
measure: Change From Baseline to Primary Endpoint CAPS-5 Total Severity Score
timeFrame: Baseline to Primary Endpoint (Visit 16, approximately 2 months later)
Secondary outcomes:
measure: Baseline Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline (screening)
measure: Primary Endpoint Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Primary Endpoint (Visit 16, approximately 2 months later)
measure: Baseline Patient Beck Depression Inventory-II (BDI-II)
timeFrame: Baseline (screening)
measure: Primary Endpoint Patient Beck Depression Inventory-II (BDI-II)
timeFrame: Primary Endpoint (Visit 16, approximately 2 months later)
measure: Baseline Patient Couples Satisfaction Index (CSI)
timeFrame: Baseline (screening)
measure: Primary Endpoint Patient Couples Satisfaction Index (CSI)
timeFrame: Primary Endpoint (Visit 16, approximately 2 months later)
measure: Baseline Partner Couples Satisfaction Index (CSI)
timeFrame: Baseline (screening)
measure: Primary Endpoint Partner Couples Satisfaction Index (CSI)
timeFrame: Primary Endpoint (Visit 16, approximately 2 months later)
measure: Baseline Trauma and Attachment Beliefs Scale (TABS)
timeFrame: Baseline (screening)
measure: Primary Endpoint Trauma and Attachment Beliefs Scale (TABS)
timeFrame: Primary Endpoint (Visit 16, approximately 2 months later)
measure: Baseline Emotion Regulation Questionnaire (ERQ) Reappraisal Subscale
timeFrame: Baseline (screening)
measure: Primary Endpoint Emotion Regulation Questionnaire (ERQ) Reappraisal Subscale
timeFrame: Primary Endpoint (Visit 16, approximately 2 months later)
measure: Baseline Emotion Regulation Questionnaire (ERQ) Suppression Subscale
timeFrame: Baseline (screening)
measure: Primary Endpoint Emotion Regulation Questionnaire (ERQ) Suppression Subscale
timeFrame: Primary Endpoint (Visit 16, approximately 2 months later)
measure: Baseline Patient PTSD Checklist-5 (PCL-5)
timeFrame: Baseline (screening)
measure: Primary Endpoint Patient PTSD Checklist-5 (PCL-5)
timeFrame: Primary Endpoint (Visit 16, approximately 2 months later)
measure: Baseline Partner-rated PTSD Checklist-5 (PCL-5)
timeFrame: Baseline (screening)
measure: Primary Endpoint Partner-rated PTSD Checklist-5 (PCL-5)
timeFrame: Primary Endpoint (Visit 16, approximately 2 months later)
Other outcomes:
Locations:
city: Mount Pleasant
country: United States
facility: Offices of Michael Mithoefer MD
state: South Carolina
Study officials:
affiliation: Private Practice
name: Michael C Mithoefer, MD
role: PRINCIPAL_INVESTIGATOR
References: