rTMS and Cognitive-behavioral Therapy for Cocaine Use Disorder (NCT05974202) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
rTMS and Cognitive-behavioral Therapy for Cocaine Use Disorder
United States30 participantsStarted 2026-05-01
Plain-language summary
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.
Who can participate
Age range22 Years – 65 Years
SexALL
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Inclusion criteria
✓. Age 22-65;
✓. Able to give informed consent and comply with study procedures;
✓. Meets DSM-5 criteria for current moderate/severe CUD and are treatment-seeking;
✓. Used cocaine at least 9 days in the past 28 days, with at least weekly cocaine use;
✓. Agree to no more than moderate alcohol consumption (\<15 drinks/week for men and \<8 drinks/week for women) and to avoid using amphetamine/methamphetamine and non-prescribed benzodiazepines or barbiturates; and
✓. Women of childbearing potential must agree to use a method of contraception with proven efficacy and agree to not become pregnant during the study.
Exclusion criteria
✕. Meets DSM-5 criteria for current moderate/severe major depressive episode, OCD, bipolar disorder, schizophrenia or any psychotic disorder other than transient psychosis due to substance use;
✕. Hamilton Depression Rating Scale score \> 17;
What they're measuring
1
Percentage of participants receiving at least 10 out of 15 rTMS sessions
Timeframe: 3 weeks
2
Number of participants in the active rTMS arm experiencing an rTMS-emergent adverse event
Timeframe: 3 weeks
3
Percent change of medial prefrontal cortex and dorsal anterior cingulate cortex activity on fMRI during the Drug Stroop Task
Timeframe: 3 weeks
4
Percentage of participants who achieve 3 weeks of abstinence during the final 12 weeks of the trial
✕. Meets DSM-5 criteria for current moderate/severe other substance use disorder (aside from tobacco use disorder; physiologic dependence on any other substance other than nicotine, including alcohol, is exclusionary);
✕. Heavy weekly alcohol drinking as defined by an average of \>14 drinks/week for men or \>7 drinks/week for women on average during the past 28 days;
✕. Prior alcohol, benzodiazepine, or barbiturate withdrawal that resulted in hospitalization, medical detoxification, or resulted in seizures or delirium tremens;
✕. More than twice weekly use of non-prescribed medications/drugs that may change the seizure threshold, including benzodiazepines, barbiturates, GHB/GBL, amphetamines/methamphetamine;
✕. Any other current DSM-5 psychiatric disorder(s) that in the investigator's judgment are unstable, would be disrupted by study procedures, or are likely to require pharmacotherapy or psychotherapy during the study period;