search
Back to results

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

Primary Purpose

Obsessive-Compulsive Disorder

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
3,4-Methyl enedioxy methamphetamine
Methamphetamine
Cognitive Behavioral Therapy (CBT)
Sponsored by
Carolyn Rodriguez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring OCD, MDMA, OCD CBT, Cognitive Behavioral Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    MDMA-assisted cognitive behavioral therapy

    Methamphetamine-assisted cognitive behavioral therapy

    Arm Description

    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).

    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).

    Outcomes

    Primary Outcome Measures

    Chnage in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 13, 2023
    Last Updated
    March 28, 2023
    Sponsor
    Carolyn Rodriguez
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05783817
    Brief Title
    MDMA-Assisted CBT for OCD (MDMA-CBT4OCD Study)
    Acronym
    MDMA-CBT4OCD
    Official Title
    MDMA-Assisted Cognitive Behavioral Therapy (CBT) Compared With Methamphetamine-Assisted CBT in Obsessive-Compulsive Disorder (OCD): A Phase II Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2023 (Anticipated)
    Primary Completion Date
    December 1, 2026 (Anticipated)
    Study Completion Date
    December 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Carolyn Rodriguez

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obsessive-Compulsive Disorder
    Keywords
    OCD, MDMA, OCD CBT, Cognitive Behavioral Therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    Participants will be randomized with a 1:1 allocation to either MDMA-assisted CBT or methamphetamine-assisted CBT (active control).
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    MDMA-assisted cognitive behavioral therapy
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Methamphetamine-assisted cognitive behavioral therapy
    Arm Type
    Active Comparator
    Arm Description
    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).
    Intervention Type
    Drug
    Intervention Name(s)
    3,4-Methyl enedioxy methamphetamine
    Other Intervention Name(s)
    MDMA
    Intervention Description
    MDMA (3,4 methylenedioxymethamphetamine) is a synthetic, psychoactive drug that is chemically similar to the stimulant methamphetamine.
    Intervention Type
    Drug
    Intervention Name(s)
    Methamphetamine
    Other Intervention Name(s)
    MA
    Intervention Description
    Methamphetamine is a stimulant that affects the central nervous system. This is used as a control in the study.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cognitive Behavioral Therapy (CBT)
    Intervention Description
    Cognitive Behavioral Therapy with exposure and response prevention performed by therapist team.
    Primary Outcome Measure Information:
    Title
    Chnage in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)
    Description
    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.
    Time Frame
    Baseline (Visit 1) to End of Intervention (Visit 13), up to 2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Pavithra Mukunda, MS
    Phone
    650-723-4095
    Email
    ocdresearch@stanford.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Carolyn Rodriguez, MD, PhD
    Organizational Affiliation
    Stanford University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    33972795
    Citation
    Mitchell JM, Bogenschutz M, Lilienstein A, Harrison C, Kleiman S, Parker-Guilbert K, Ot'alora G M, Garas W, Paleos C, Gorman I, Nicholas C, Mithoefer M, Carlin S, Poulter B, Mithoefer A, Quevedo S, Wells G, Klaire SS, van der Kolk B, Tzarfaty K, Amiaz R, Worthy R, Shannon S, Woolley JD, Marta C, Gelfand Y, Hapke E, Amar S, Wallach Y, Brown R, Hamilton S, Wang JB, Coker A, Matthews R, de Boer A, Yazar-Klosinski B, Emerson A, Doblin R. MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nat Med. 2021 Jun;27(6):1025-1033. doi: 10.1038/s41591-021-01336-3. Epub 2021 May 10.
    Results Reference
    result

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs