N/A
N=129
rTMS for Stimulant Use Disorders
Cocaine Use Disorder · Methamphetamine Abuse · Cocaine Dependence · Methamphetamine Dependence · Stimulant Use
Bottom Line
View on ClinicalTrials.gov: NCT04907357 ↗Enrolled (actual)
129
Serious AEs
5.4%
Results posted
Feb 2025
Primary outcome: Primary: Percentage of Participants Who Receive at Least 20 Sessions of rTMS/Sham Over the Treatment Period. — 29; 40; 37; 23 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- rTMS (Device); Sham (Placebo) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Receive at Least 20 Sessions of rTMS/Sham Over the Treatment Period. |
29; 40; 37; 23 | — |
| SECONDARY Negative UDS From Weekly UDS |
38; 30; 369; 384 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 18-65, inclusive
- Have a diagnosis of moderate or severe Cocaine or Methamphetamine Use Disorder (CUD/MUD) over the past 12 months (as determined by DSM-5 diagnostic criteria).
- Have used cocaine or methamphetamine on at least 10 of the last 30 days (based on Timeline Follow-Back).
- Be interested in decreasing cocaine and/or methamphetamine use.
- If female, willing to use appropriate birth control method during the treatment phase of the study.
- Be able to understand the study procedures and provide written informed consent to participate in the study.
- If prescribed benzodiazepines or anticonvulsants, must be on a stable dose for at least 4 weeks prior to consent.
Exclusion Criteria
- A Diagnostic and Statistical Manual (DSM-5) diagnosis of moderate or severe SUD of any substance other than cocaine or methamphetamine based on DSM-5.
- History of a serious medical disorder that, in the opinion of the Medical Clinician, would make it unsafe to participate in the study or may prevent collection of study data.
- Is currently engaged in formal SUD treatment.
- Documented history of unprovoked seizure (lifetime) or any seizure in the past 6 months.
- Documented history of brain lesion(s) and/or tumor(s).
- Metal implants or non-removable metal objects above the waist.
- Currently pregnant.
- Lifetime history of prior clinical treatment with TMS.
- Current or lifetime bipolar disorder.
- Current psychotic disorder or psychotic depression.
- Serious risk of homicide or suicide.
- Are a prisoner or in police custody at the time of eligibility screening.
- Previously randomized as a participant in the study.
- Planned admission to a residential treatment facility or other formal SUD treatment program.
- Unwilling or unable to follow study procedures.
Data sourced from ClinicalTrials.gov (NCT04907357). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.