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
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 the study is to investigate the feasibility, safety, and effect of rTMS on mPFC/dACC activity using a combination of fMRI and clinical outcome measures, when used as an augmentation to CBT. Our hypothesis is that we will meet the following milestones prior to moving forward to the UH3 phase (a clinical trial for CUD). * Feasibility: At least 75% of participants will receive at least 15 out of 20 rTMS sessions with no participants experiencing a study-related serious adverse event * Mechanism: Compared to baseline, after 1 week of rTMS, participants who received active rTMS will demonstrate a 15% decrease in RSFC (resting state functional connectivity) between the DLPFC (dorsolateral prefrontal cortex) and anterior cingulate * Efficacy: During the final 12 weeks of the trial (weeks 2-13), at least 15% of participants who received active rTMS will demonstrate 3 consecutive weeks of abstinence Participants will: * Have two brain MRI scans; * Undergo 1 week of daily rTMS (or sham) treatments (up to 20 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

First listed
Aug 3, 2023
Start date
Aug 14, 2026
Status verified
Aug 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 iTBS rTMS
    Daily repetitive transcranial magnetic brain stimulation for 1 week (20 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 15 out of 20 rTMS sessions [ Time Frame: 1 week ]

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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