MDMA-Assisted CBT for OCD (MDMA-CBT4OCD Study)

Part of paid clinical trials in Palo Alto, California.

Sponsor
Carolyn Rodriguez
Study ID
NCT05783817
Phase
PHASE2
Status
Recruiting
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Conditions

  • Obsessive-Compulsive Disorder

Eligibility Criteria

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

Interventions

  • 3,4-Methyl enedioxy methamphetamine — DRUG
    MDMA (3,4 methylenedioxymethamphetamine) is a synthetic, psychoactive drug that is chemically similar to the stimulant methamphetamine.
  • Methamphetamine — DRUG
    Methamphetamine is a stimulant that affects the central nervous system. This is used as a control in the study.
  • Cognitive Behavioral Therapy (CBT) — BEHAVIORAL
    Cognitive Behavioral Therapy with exposure and response prevention performed by therapist team.

Study Details

The study assesses the safety and preliminary effectiveness of MDMA-assisted cognitive behavioral therapy in participants diagnosed with obsessive-compulsive disorder (OCD).

Key Dates

Start date
Sep 10, 2025
Status verified
Mar 2026
Primary completion
Dec 1, 2026
Completion
Dec 1, 2026

Study Design

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

Arms

  • Experimental: MDMA-assisted cognitive behavioral therapy
    Administration of 80mg MDMA HCl (with a supplemental dose offered 1.5 to 2 hours later of 40 mg MDMA HCl) in combination with cognitive behavioral therapy (CBT).
  • Active Comparator: Methamphetamine-assisted cognitive behavioral therapy
    Administration of 10mg methamphetamine (with a supplemental dose offered 1.5 to 2 hours later of 5 mg methamphetamine) in combination with cognitive behavioral therapy (CBT).

Primary Outcome Measure

Chnage in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS) [ Time Frame: Baseline (Visit 1) to End of Intervention (Visit 13), up to 2 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford University Medical CenterPalo AltoCalifornia94305
Alessa Gaeta, BS
[email protected]
650-723-4095

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By research site
Stanford University Medical Center· Palo Alto, CA

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