Cocaine Use DisorderCTN-0108NCT04907357
rTMS for Stimulant Use Disorders
A study testing rTMS in people with Cocaine Use Disorder and Methamphetamine Abuse, run by Medical University of South Carolina at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cocaine Use Disorder, Methamphetamine Abuse, Cocaine Dependence
- What is being tested?
- rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- 4 sitesUnited States
- Study dates
- 4 Feb 2022to 7 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Texas Southwestern
Dallas, Texas, 75390
University of Texas Health Science Center San Antonio
San Antonio, Texas, 78229
Wake Forest
Winston-Salem, North Carolina, 27101
About this study
Official title: rTMS for Stimulant Use Disorders (CTN-0108)
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.
Read the detailed description
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.
- Conditions
- Cocaine Use Disorder, Methamphetamine Abuse, Cocaine Dependence, Methamphetamine Dependence, Stimulant Use, Stimulant Abuse
- Being tested
- rTMS, Sham (Placebo)
- Keywords
- Stimulant, Cocaine, Methamphetamine, Repetitive Transcranial Magnetic Stimulation, rTMS
- Medical subject headings
- Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
Also called Repetitive Transcranial Magnetic Stimulation, TMS
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).
Sham (Placebo)Device
Also called Sham Repetitive Transcranial Magnetic Stimulation
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).
| Study group | Role | What they receive |
|---|---|---|
| rTMS | Active comparator | Participants will receive up to 30 rTMS sessions within the 8-week treatment period. Receives: Device: rTMS |
| Sham (Placebo) | Sham comparator | Participants will receive up to 30 sham rTMS sessions within the 8-week treatment period. Receives: Device: Sham (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From first treatment session (Week 1, first study visit) to end of treatment at 8 weeks
Secondary outcomes (1)
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.
Measured: From first treatment week (Week 1) to end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start4 Feb 2022
- Primary completion5 Apr 2024
- Study completion7 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cocaine Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a double-blind, sham-controlled study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Kathleen Brady, Medical University of South Carolina
- Investigators
- Kathleen T Brady, MD PHD, Principal investigator, Medical University of South CarolinaMadhukar Trivedi, MD, Principal investigator, University of Texas South Western
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04907357
- Sponsor's protocol ID
- 00107688
- Other IDs
- UG1DA013727
- Acronym
- CTN-0108
- Status last verified
- Jun 2025
- First submitted
- 25 May 2021
- Last updated
- 3 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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
Publications
Atoui Z, Egan D, Jha MK, Hartwell K, Toll R, Sonne S, Brunner-Jackson B, Subramaniam G, McCauley JL, Trivedi M, Brady K. Repetitive transcranial magnetic stimulation for stimulant use disorders (STIMULUS): protocol for a multi-site, double-blind, randomized controlled trial. Addict Sci Clin Pract. 2025 May 8;20(1):40. doi: 10.1186/s13722-025-00567-w.
PubMed 40336040
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- rTMS for Stimulant Use Disorders (CTN-0108)
- ClinicalTrials.gov ID
- NCT04907357
- Acronym / sponsor ID
- CTN-0108 / 00107688
- Conditions
- Cocaine Use Disorder, Methamphetamine Abuse, Cocaine Dependence, Methamphetamine Dependence, Stimulant Use, Stimulant Abuse
- Keywords
- Stimulant, Cocaine, Methamphetamine, Repetitive Transcranial Magnetic Stimulation, rTMS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 4 Feb 2022 (actual)
- Primary completion
- 5 Apr 2024 (actual)
- Study completion
- 7 Jun 2024 (actual)
- First posted
- 28 May 2021 (actual)
- Results
- Posted 20 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a double-blind, sham-controlled study.
| Arm | Type | Receives |
|---|---|---|
| rTMS | Active comparator | Device: rTMSParticipants will receive up to 30 rTMS sessions within the 8-week treatment period. |
| Sham (Placebo) | Sham comparator | Device: Sham (Placebo)Participants will receive up to 30 sham rTMS sessions within the 8-week treatment period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rTMSAlso: Repetitive Transcranial Magnetic Stimulation, TMSEach 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). | Device | rTMS |
| Sham (Placebo)Also: Sham Repetitive Transcranial Magnetic StimulationEach 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). | Device | Sham (Placebo) |
Primary outcome
Percentage of Participants Who Receive at Least 20 Sessions of rTMS/Sham Over the Treatment Period.
Time frame: From first treatment session (Week 1, first study visit) to end of treatment at 8 weeks
Treatment session attendance and completion will be tracked over the course of the study, and this record will constitute the primary feasibility outcome.
1 secondary outcome
Negative UDS From Weekly UDS
Time frame: From first treatment week (Week 1) to end of treatment at 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40336040Atoui Z, Egan D, Jha MK, Hartwell K, Toll R, Sonne S, Brunner-Jackson B, Subramaniam G, McCauley JL, Trivedi M, Brady K. Repetitive transcranial magnetic stimulation for stimulant use disorders (STIMULUS): protocol for a multi-site, double-blind, randomized controlled trial. Addict Sci Clin Pract. 2025 May 8;20(1):40. doi: 10.1186/s13722-025-00567-w.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen T Brady, MD PHD principal investigator
Medical University of South Carolina
Madhukar Trivedi, MD principal investigator
University of Texas South Western
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS in people with Cocaine Use Disorder and Methamphetamine Abuse, run by Medical University of South Carolina at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Receive at Least 20 Sessions of rTMS/Sham Over the Treatment Period. (time frame: From first treatment session (Week 1, first study visit) to end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04907357, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.