- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05783817
MDMA-Assisted CBT for OCD (MDMA-CBT4OCD Study) (MDMA-CBT4OCD)
February 7, 2024 updated by: Carolyn Rodriguez
MDMA-Assisted Cognitive Behavioral Therapy (CBT) Compared With Methamphetamine-Assisted CBT in Obsessive-Compulsive Disorder (OCD): A Phase II Study
The study assesses the safety and preliminary effectiveness of MDMA-assisted cognitive behavioral therapy in participants diagnosed with obsessive-compulsive disorder (OCD).
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Obsessive-Compulsive Disorder (OCD) is a chronic and disabling disorder that costs the economy over $2 billion annually and represents a significant public health problem.
The proposed projects tests whether 3,4-Methylenedioxymethamphetamine (MDMA) reduces OCD symptoms.
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Pavithra Mukunda, MS
- Phone Number: 650-723-4095
- Email: ocdresearch@stanford.edu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- At least 18 years old
- Fluent in speaking and reading the predominantly used or recognized language of the study site
- Able to swallow pills
- Meet the criteria for OCD diagnosis
- YBOCS total score of at least 16
- Not on psychotropic medications 1 month prior to study enrollment
- Able to tolerate a treatment-free period
- Able to tolerate study procedures
- Failed at least 1 prior trial of standard first-line OCD treatment
- Agree to the following lifestyle modifications: comply with requirements for fasting and refraining from certain medications prior to the Experimental Session, not enroll in any other interventional clinical trials during the duration of the study, and commit to medication dosing, therapy, and study procedures.
Exclusion Criteria:
- Pregnant or nursing, or able to become pregnant and are not practicing an effective means of birth control
- Weigh less than 48 kilograms (kgs)
- Any current problem which, in the opinion of the investigator or study physician, might interfere with participation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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).
|
MDMA (3,4 methylenedioxymethamphetamine) is a synthetic, psychoactive drug that is chemically similar to the stimulant methamphetamine.
Other Names:
Cognitive Behavioral Therapy with exposure and response prevention performed by therapist team.
|
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).
|
Cognitive Behavioral Therapy with exposure and response prevention performed by therapist team.
Methamphetamine is a stimulant that affects the central nervous system.
This is used as a control in the study.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Change in OCD severity is measured by the YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions.
For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40.
The higher the number on the YBOCS, the more severe the symptoms.
Response is defined as at least a 35% reduction on the YBOCS.
|
Baseline (Visit 1) to End of Intervention (Visit 13), up to 2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Carolyn Rodriguez, MD, PhD, Stanford University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 1, 2024
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
March 13, 2023
First Submitted That Met QC Criteria
March 13, 2023
First Posted (Actual)
March 24, 2023
Study Record Updates
Last Update Posted (Actual)
February 8, 2024
Last Update Submitted That Met QC Criteria
February 7, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Personality Disorders
- Anxiety Disorders
- Compulsive Personality Disorder
- Obsessive-Compulsive Disorder
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Uptake Inhibitors
- Central Nervous System Stimulants
- Sympathomimetics
- Adrenergic Uptake Inhibitors
- Methamphetamine
Other Study ID Numbers
- 66547
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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