MDMA-assisted Cognitive Processing Therapy Versus Cognitive Processing Therapy for Veterans With Severe Posttraumatic Stress Disorder

Part of paid clinical trials in Palo Alto, California.

Sponsor
Patricia Suppes
Study ID
NCT05837845
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MDMA — DRUG
    Participants will receive a flexible divided-dose of MDMA HCl plus therapy at three Experimental Sessions, as well as non-drug Preparatory and Integration Sessions
  • Cognitive Processing Therapy — BEHAVIORAL
    Participants will receive 8-15 (average of 12) sessions of Cognitive Processing Therapy
  • MDMA-assisted Cognitive Processing Therapy (MDMA-aCPT) — BEHAVIORAL
    Participants assigned to MDMA-aCPT will undergo a therapeutic approach administered by trained therapists. MDMA seems to engender internal awareness that even painful feelings that arise are an important part of the therapeutic process. MDMA can elicit feelings of empathy, love, and deep appreciation, along with a clearer perspective of the trauma as a past event, a more accurate perspective about its significance, and a heightened awareness of the support and safety that exists in the present. A combined treatment of MDMA and therapy may be especially useful for treating PTSD because MDMA can attenuate the fear response of a perceived threat to one's emotional integrity and decrease defensiveness without blocking access to memories or preventing a deep and genuine experience of emotion.

Study Details

In partnership with the Veterans Affairs (VA) Palo Alto Health Care System and Stanford University, this study aims to evaluate clinical outcomes, assess implementation feasibility, and health economics of MDMA-assisted Cognitive Processing Therapy (MDMA-aCPT) in the treatment of posttraumatic stress disorder (PTSD). Through a randomized comparison of MDMA-aCPT versus Cognitive Processing Therapy (CPT), a VA gold standard treatment for PTSD, the proposed study will set the stage for understanding the potential use and application of MDMA-aCPT for PTSD within the VA system.

Key Dates

Start date
Feb 10, 2025
Status verified
Jul 2025
Primary completion
May 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MDMA-assisted Cognitive Processing Therapy (MDMA-aCPT)
    This arm consists of 8-15 virtual CPT sessions (average of 12), one 90-minute, non-drug Preparatory Session, three Experimental Sessions with MDMA (\~8 hours), and three 90-minute, non-drug Integration Sessions, occurring over a 9-15-week Treatment Period. Standardized homework is assigned at each CPT session to promote the practice of the skills taught in the session. Participants will receive 80mg MDMA HCl for the first Experimental Session and will have the option of a supplemental dose of 40mg MDMA HCI 1.5-2 hours after the initial dose. For the second and third Experimental Sessions, participants will receive either 80mg or 120mg MDMA HCl as the initial dose, and an optional supplemental dose of 40mg or 60mg MDMA HCl 1.5-2 hours after the initial dose. Participants interested in receiving CPT treatment alone after study completion will have the option to be referred to their local VA PTSD Clinical Team for services 6 months after all study visits are completed.
  • Experimental: Cognitive processing therapy
    This arm consists of 8-15 virtual CPT treatment sessions lasting approximately 1-1.5 hours, occurring over a \~12-16-week Treatment Period. These sessions will take place approximately one week apart. Standardized homework is assigned at each session to promote the practice of the skills taught in the session. Participants will have the option to crossover to the MDMA-aCPT arm 6 months after all study visits are completed.

Primary Outcome Measure

Change in Clinician Administered PTSD Scale (CAPS-5) Total Severity Score [ Time Frame: From Baseline to approximately 4 months post-baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Palo Alto Health Care System / Stanford UniversityPalo AltoCalifornia94304
Anna Donnelly
[email protected]
650-849-0161
Trisha Suppes, MD, PhD (PRINCIPAL_INVESTIGATOR)
Shannon Wiltsey Stirman, PhD (SUB_INVESTIGATOR)

Find similar trials in Palo Alto, CA

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
VA Palo Alto Health Care System / Stanford University· Palo Alto, CA

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