An interventional study of rTMS and Sham (Placebo) in Cocaine Use Disorder, Methamphetamine Abuse and Cocaine Dependence, sponsored by Medical University of South Carolina. Completed at 4 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-07-03.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Treatment
The purpose of the study is to determine feasibility of repetitive transcranial magnetic stimulation (rTMS) for individuals with moderate to severe cocaine or methamphetamine use disorder (CUD/MUD). Potential participants will be age 18-65, and interested in cutting down or stopping use. Participants will be randomized to one of two groups; groups will receive rTMS or sham rTMS (placebo) over the course of an 8-week treatment period, and complete follow-up assessments at the end of treatment, 12, and 16 weeks post-randomization.
The study will be a randomized, double-blind, sham-controlled trial comparing rTMS vs. placebo delivered over an 8-week treatment period. After assessment and inclusion into the study, participants will be randomized to receive up to 30 sessions of either rTMS or placebo treatments. The target minimum number of rTMS/placebo treatments is 20 treatments over 8 weeks. The secondary objective is to gather preliminary data on the efficacy of rTMS for individuals with moderate to severe CUD or MUD. Follow-up visits occur at end of treatment and at 12- and 16-weeks following randomization.
Other study procedures:
Actigraphy: To assess daily sleep quality during weeks 1-8, the ActiGraph wristband device will record, sleep latency, sleep duration, and intervals of waking during the sleep period.
Electroencephalography (EEG): EEG will be obtained after randomization and again at week 4, to explore the potential for EEG to be used as a biomarker of treatment response.
Cognitive-Behavioral Educational Intervention: Participants in both conditions (rTMS and placebo) will be encouraged to participate in a mobile app-based educational intervention based on principles of Cognitive Behavioral Therapy (CBT) for Substance Use Disorder (SUD).
Daily Assessments: Brief, electronic remote surveys will be administered to participants daily until week 16 follow-up time point and will assess use of primary substance of abuse, craving, ability to resist use, overall mood, and self-rated sleep quality.
Urine Drug Screens (UDS): UDS will be collected at screening, randomization, every treatment session, and at follow-up visits.
Urine pregnancy tests: Pregnancy testing for all female participants will be performed at screening, randomization, and monthly during the treatment period.
Physical exam: A physical exam will be performed at screening.
Questionnaires: A battery of study assessments will be completed to further inform findings regarding feasibility and effects of rTMS on individuals with stimulant use disorders.
415 studies on the registry are indexed under Cocaine-Related Disorders; 12 are open to participants now.
This study's enrollment of 129 is above the median of 60 across 312 interventional studies indexed under Cocaine-Related Disorders.
Browse Cocaine-Related Disorders studies →Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.
Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive up to 30 rTMS sessions within the 8-week treatment period.
Device: rTMS
Participants will receive up to 30 sham rTMS sessions within the 8-week treatment period.
Device: Sham (Placebo)
Each rTMS session will consist of 75 rTMS trains of 10 Hz for 4 seconds (40 pulses per train) with inter-train interval (ITI) of 11 seconds (a total of 3000 stimuli per session) over the left dorsolateral prefrontal cortex (DLPFC).
Also known as: Repetitive Transcranial Magnetic Stimulation, TMS
Each sham rTMS session will consist of 75 rTMS trains of 10 Hz for 4 seconds (40 pulses per train) with inter-train interval (ITI) of 11 seconds (a total of 3000 stimuli per session) over the left dorsolateral prefrontal cortex (DLPFC). In the placebo condition the magnetic field will be delivered in the opposite direction (away from the brain).
Also known as: Sham Repetitive Transcranial Magnetic Stimulation
Percentage of Participants Who Receive at Least 20 Sessions of rTMS/Sham Over the Treatment Period.
Treatment session attendance and completion will be tracked over the course of the study, and this record will constitute the primary feasibility outcome.
Time frame: From first treatment session (Week 1, first study visit) to end of treatment at 8 weeks
Negative UDS From Weekly UDS
A negative UDS for participants with cocaine as primary substance would be a UDS absent of cocaine; a negative UDS for participants with methamphetamine as primary substance would be a UDS absent of methamphetamine.
Time frame: From first treatment week (Week 1) to end of treatment at 8 weeks
| Milestone | Sham (Placebo) | rTMS |
|---|---|---|
| Started | 63 | 66 |
| Completed | 51 | 45 |
| Not completed | 12 | 21 |
| Withdrew: Death | 0 | 1 |
| Withdrew: Lost to follow-up | 9 | 18 |
| Withdrew: Physician decision | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Unable to attend visits | 1 | 0 |
| Withdrew: Incarcerated | 1 | 1 |
Treatment session attendance and completion will be tracked over the course of the study, and this record will constitute the primary feasibility outcome.
| Participants | rTMS | Sham (Placebo) |
|---|---|---|
| Attended 20 or more rTMS/sham sessions | 29 | 40 |
| Attended fewer than 20 rTMS/sham sessions | 37 | 23 |
A negative UDS for participants with cocaine as primary substance would be a UDS absent of cocaine; a negative UDS for participants with methamphetamine as primary substance would be a UDS absent of methamphetamine.
| Urine drug screens | rTMS | Sham (Placebo) |
|---|---|---|
| Negative UDS | 38 | 30 |
| Positive UDS | 369 | 384 |
Collected over 16 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| rTMS | 1/66 (1.5%) | 5/66 (7.6%) | 45/66 (68.2%) |
| Sham (Placebo) | 0/63 (0%) | 2/63 (3.2%) | 29/63 (46%) |
| Event | rTMS | Sham (Placebo) |
|---|---|---|
| Suicidal IdeationPsychiatric disorders | 0/66 | 1/63 |
| Suicide attemptPsychiatric disorders | 0/66 | 1/63 |
| OverdoseInjury, poisoning and procedural complications | 1/66 | 0/63 |
| Pulmonary sepsisInfections and infestations | 1/66 | 0/63 |
| Cerebral vascular accidentNervous system disorders | 1/66 | 0/63 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 1/66 | 0/63 |
| FallInjury, poisoning and procedural complications | 1/66 | 0/63 |
| Event | rTMS | Sham (Placebo) |
|---|---|---|
| Medical Device Site PainGeneral disorders | 19/66 | 10/63 |
| HeadacheNervous system disorders | 7/66 | 6/63 |
| Medical device site discomfortGeneral disorders | 7/66 | 5/63 |
| Headache device relatedNervous system disorders | 5/66 | 6/63 |
| Application site discomfortGeneral disorders | 6/66 | 2/63 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/66 | 5/63 |
| DizzinessNervous system disorders | 5/66 | 2/63 |
| Back PainMusculoskeletal and connective tissue disorders | 5/66 | 4/63 |
| Procedural HeadacheInjury, poisoning and procedural complications | 5/66 | 2/63 |
| NauseaGastrointestinal disorders | 2/66 | 4/63 |
| Age, Categorical(Participants) | rTMS | Sham (Placebo) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 65 | 62 | 127 |
| >=65 years | 1 | 1 | 2 |
| Age, Continuous(years) | rTMS | Sham (Placebo) | Total |
|---|---|---|---|
| Mean | 46.8 ± 9.38 | 46.8 ± 10.20 | 46.8 ± 9.77 |
| Sex: Female, Male(Participants) | rTMS | Sham (Placebo) | Total |
|---|---|---|---|
| Female | 20 | 13 | 33 |
| Male | 46 | 50 | 96 |
| Ethnicity (NIH/OMB)(Participants) | rTMS | Sham (Placebo) | Total |
|---|---|---|---|
| Hispanic or Latino | 11 | 8 | 19 |
| Not Hispanic or Latino | 55 | 55 | 110 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | rTMS | Sham (Placebo) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 26 | 28 | 54 |
| White | 32 | 30 | 62 |
| More than one race | 3 | 2 | 5 |
| Unknown or Not Reported | 4 | 2 | 6 |
| Region of Enrollment(participants) | rTMS | Sham (Placebo) | Total |
|---|---|---|---|
| United States | 66 | 63 | 129 |
| Primary substance of use(Participants) | rTMS | Sham (Placebo) | Total |
|---|---|---|---|
| Cocaine | 27 | 26 | 53 |
| Methamphetamine | 39 | 37 | 76 |
| Major Depressive Episode(Participants) | rTMS | Sham (Placebo) | Total |
|---|---|---|---|
| Present | 5 | 4 | 9 |
| Absent | 61 | 59 | 120 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — The lead investigator will submit coded individual level data on Clinical Trials Network (CTN) study participants to the Data Management Center contracted by National Institute on Drug Abuse (NIDA) Center for CTN. These data may include but are not limited to: demographic information, date of birth, medical history, substance use history, psychiatric history, objective measures of substance use and psychiatric status, HIV status and genetic information. Data will be submitted without information that could readily identify the study participant (i.e. We will not share medical record numbers, social security numbers or participant names or phone numbers with the Data Management Center). De-identified data will be made publicly available per the CTN's policies
Supporting information: Study protocol
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Medical University of South Carolina