rTMS and Cognitive-behavioral Therapy for Cocaine Use Disorder

Part of paid clinical trials in New York, New York.

Sponsor
New York State Psychiatric Institute
Study ID
NCT05974202
Status
Not Yet Recruiting

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Conditions

  • Cocaine Dependence
  • Cocaine Use
  • Cocaine Use Disorder
  • Cocaine Use Disorder, Moderate
  • Cocaine Use Disorder, Severe

Eligibility Criteria

Sex
ALL
Age
22 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Active H7-coil repetitive transcranial magnetic stimulation (rTMS) — DEVICE
    A magnetic current created by the device creates an electrical current in the brain to stimulate the medial prefrontal cortex and dorsal anterior cingulate cortex.
  • Sham H7-coil repetitive transcranial magnetic stimulation (rTMS) — DEVICE
    A sham coil is in the same helmet as the active coil. The sham coil mimics the sound, scalp sensations, and facial muscle activation caused by the active coil, but does not create an electrical current in the brain.

Study Details

The goal of this clinical trial is to compare the effects of active repetitive transcranial magnetic stimulation (rTMS) to sham (placebo) rTMS prior to cognitive-behavioral therapy (CBT) as a treatment for adults with cocaine use disorder. The main questions it aims to answer are: * Is rTMS safe and feasible as an augmentation for CBT for the treatment of cocaine use disorder? * What is the brain mechanism of rTMS? * Will active rTMS (compared to sham rTMS) followed by CBT help adults with cocaine use disorder achieve abstinence from cocaine? Participants will: * Have two brain MRI scans; * Undergo 3 weeks of daily rTMS (or sham) treatments (15 sessions), and; * Have 12 weeks of once-weekly cognitive-behavioral therapy for the treatment of cocaine use disorder. Researchers will compare active (real) rTMS to sham (placebo) rTMS. All participants will receive cognitive-behavioral therapy. The former principle investigator, Dr. Derek Blevins, has vacated his position (February 2025), and has transferred the principle investigator role to Dr. John Mariani, the STARS Clinic Director.

Key Dates

Start date
May 1, 2026
Status verified
Apr 2026
Primary completion
Apr 28, 2028
Completion
Apr 28, 2028

Study Design

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

Arms

  • Active Comparator: Active (high-frequency) rTMS
    Daily high-frequency (10 Hz) repetitive transcranial magnetic brain stimulation for 3 weeks (15 sessions).
  • Placebo Comparator: Sham (placebo) rTMS
    Sham rTMS uses the same device and mimics the auditory and scalp sensations without stimulating the brain.

Primary Outcome Measure

Percentage of participants receiving at least 10 out of 15 rTMS sessions [ Time Frame: 3 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
New York State Psychiatric Institute (NYSPI) / Substance Treatment and Research Service (STARS)New YorkNew York10019
Substance Treatment and Research Service (STARS)
[email protected]
212-923-3031
Daniel Brooks, LCSW
[email protected]
6467748181
John Mariani, MD (PRINCIPAL_INVESTIGATOR)

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By research site
New York State Psychiatric Institute (NYSPI) / Substance Treatment and Research Service (STARS)· New York, NY

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