Obsessive-Compulsive Disorder
Conditions
Keywords
OCD, MDMA, OCD CBT, Cognitive Behavioral Therapy
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.
Interventions
DRUG3,4-Methyl enedioxy methamphetamine
MDMA (3,4 methylenedioxymethamphetamine) is a synthetic, psychoactive drug that is chemically similar to the stimulant methamphetamine.
DRUGMethamphetamine
Methamphetamine is a stimulant that affects the central nervous system. This is used as a control in the study.
BEHAVIORALCognitive Behavioral Therapy (CBT)
Cognitive Behavioral Therapy with exposure and response prevention performed by therapist team.
Sponsors
Carolyn Rodriguez
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Participants will be randomized with a 1:1 allocation to either MDMA-assisted CBT or methamphetamine-assisted CBT (active control).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. At least 18 years old 2. Fluent in speaking and reading the predominantly used or recognized language of the study site 3. Able to swallow pills 4. Meet the criteria for OCD diagnosis 5. YBOCS total score of at least 16 6. Not on psychotropic medications 1 month prior to study enrollment 7. Able to tolerate a treatment-free period 8. Able to tolerate study procedures 9. Failed at least 1 prior trial of standard first-line OCD treatment 10. 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
1. Pregnant or nursing, or able to become pregnant and are not practicing an effective means of birth control 2. Weigh less than 48 kilograms (kgs) 3. Any current problem which, in the opinion of the investigator or study physician, might interfere with participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chnage in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS) | 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. |
Countries
United States
Contacts
CONTACTAlessa Gaeta, MS
PRINCIPAL_INVESTIGATORCarolyn Rodriguez, MD, PhD
Stanford University
Outcome results
None listed