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rTMS and Cognitive-behavioral Therapy for Cocaine Use Disorder

Study acronym: COAST
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 3 of 4 changed
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Record History

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  1. Minor Re-verified, no change to tracked fieldsv17
  2. Notable Recruitment opened
    • Start date: Aug 8, 2026 to Aug 14, 2026
    • Site details revised
    v16
  3. Notable Primary endpoint(s) modified
    • Start date: May 1, 2026 to Aug 8, 2026
    • Eligibility criteria expanded, about 151 words
    • Study description shortened, about 182 words
    v15
  4. Notable Primary and study completion dates: Apr 2027 to Apr 28, 2028
    • Start date: Dec 15, 2025 to May 1, 2026
    v14
  5. Notable Start date: Jul 15, 2025 to Dec 15, 2025v13
Show 11 earlier versionsHide 11 earlier versions
  1. Notable Phase: Phase 2 to Not applicable
    • Start date: Apr 15, 2025 to Jul 15, 2025
    v12
  2. Minor Re-verified, no change to tracked fieldsv11
  3. Minor Site contact updatedv10
  4. Notable Start date: Jan 15, 2025 to Apr 15, 2025
    • Primary and study completion dates: Jan 2027 to Apr 2027
    • Site contact updated
    v9
  5. Notable Start date: Nov 15, 2024 to Jan 15, 2025
    • Study sites: 0 to 1
    • Primary and study completion dates: Nov 2026 to Jan 2027
    • Eligibility criteria expanded, about 8 words
    v8
  6. Notable Start date: Sep 15, 2024 to Nov 15, 2024
    • Primary and study completion dates: Sep 2026 to Nov 2026
    v7
  7. Notable Start date: Jun 15, 2024 to Sep 15, 2024
    • Primary and study completion dates: Jun 2026 to Sep 2026
    v6
  8. Notable Start date: Feb 15, 2024 to Jun 15, 2024
    • Primary and study completion dates: Feb 2026 to Jun 2026
    • Eligibility criteria revised
    v5
  9. Notable Start date: Nov 15, 2023 to Feb 15, 2024
    • Primary and study completion dates: Nov 2025 to Feb 2026
    v4
  10. Notable Start date: Sep 2023 to Nov 15, 2023
    • Primary and study completion dates: Jul 2025 to Nov 2025
    v3
  11. Minor Start date: Aug 2023 to Sep 2023v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05974202
Lead Sponsor New York State Psychiatric Institute
Collaborators: National Institute on Drug Abuse (NIDA), Columbia University
Conditions
(from sponsor)
Cocaine Use, Cocaine Dependence, Cocaine Use Disorder, Cocaine Use Disorder, Moderate, Cocaine Use Disorder, Severe
Related terms Cocaine-Related Disorders, Lymphoma, Follicular
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov