75 Participants Needed

TMS for Cocaine Use Disorder

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JV
Overseen ByJessica Vincent
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The University of Texas Health Science Center, Houston
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess effects of intermittent theta burst stimulation (iTBS) to left dorsolateral prefrontal cortex (dlPFC) and dorsomedial prefrontal cortex (dmPFC) compared to sham on electrophysiological indices of reward sensitivity and motivated attention in adults with cocaine use disorder.

Do I need to stop taking my current medications for the trial?

The trial requires participants to stop taking certain medications that increase the risk of seizures, such as clozapine, chlorpromazine, bupropion, and others, during the study. If you are on any of these medications, you will need to stop taking them to participate.

What data supports the effectiveness of this treatment for cocaine use disorder?

Research shows that intermittent theta burst stimulation (iTBS), a type of transcranial magnetic stimulation (TMS), can reduce cocaine use and cravings in people with cocaine use disorder. Studies have found that iTBS is as effective as traditional TMS methods but is quicker and more tolerable, making it a promising treatment option.12345

Is TMS safe for treating cocaine use disorder?

TMS, including iTBS, is generally considered safe and well-tolerated, with some participants experiencing mild side effects like headaches. In studies with cocaine users, most participants tolerated the treatment well, although one person experienced a temporary neurological event and cocaine-induced psychosis after stopping treatment.12346

How does the TMS treatment for cocaine use disorder differ from other treatments?

The TMS treatment for cocaine use disorder is unique because it uses intermittent theta burst stimulation (iTBS), a form of transcranial magnetic stimulation that is shorter and more tolerable than traditional methods. It targets specific brain areas involved in craving and cognitive control, potentially reducing cocaine use and cravings with fewer side effects and shorter session times compared to conventional high-frequency TMS.13467

Research Team

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Heather Webber, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

This trial is for adults with cocaine use disorder who are not seeking treatment, have moderate to severe symptoms, and a recent positive urine test for cocaine. They must understand the consent form and provide contact details. Excluded are those with other substance disorders (except marijuana or nicotine), certain medical conditions, suicidal or homicidal risks, metal implants incompatible with TMS, unsafe medication doses, specific drug use within a week of enrollment or during the study.

Inclusion Criteria

Be able to understand the consent form and provide written informed consent
I have tested positive for cocaine use.
Meet DSM-5 criteria for current cocaine use disorder of at least moderate severity (≥ 4 symptoms)
See 2 more

Exclusion Criteria

I have moderate-to-severe heart disease.
I do not have any health conditions that could affect my study participation or safety.
Taking stimulants other than cocaine
See 15 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intermittent theta burst stimulation (iTBS) to left dorsolateral prefrontal cortex (dlPFC) and dorsomedial prefrontal cortex (dmPFC) compared to sham

Immediate sessions
Multiple sessions (in-person)

Follow-up

Participants are monitored for changes in electrophysiological indices of reward sensitivity and motivated attention

4 weeks

Treatment Details

Interventions

  • Sham iTBS
  • TMS to dlPFC
  • TMS to dmPFC
Trial OverviewThe study tests intermittent theta burst stimulation (iTBS) on two brain regions: left dorsolateral prefrontal cortex (dlPFC) and dorsomedial prefrontal cortex (dmPFC), compared to sham treatment. It aims to see how iTBS affects reward sensitivity and attention in individuals with cocaine use disorder.
Participant Groups
6Treatment groups
Experimental Treatment
Group I: shami iTBS then dmPFC then dl PFCExperimental Treatment3 Interventions
Group II: sham iTBS then dlPFC then dmPFCExperimental Treatment3 Interventions
Group III: dmPFC then sham iTBS then dlPFCExperimental Treatment3 Interventions
Group IV: dmPFC then dlPFC then sham iTBSExperimental Treatment3 Interventions
Group V: dlPFC then sham iTBS then dmPFCExperimental Treatment3 Interventions
Group VI: dlPFC then dmPFC then Sham iTBSExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials
974
Recruited
361,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

Findings from Research

Intermittent theta burst stimulation (iTBS) of the prefrontal cortex has shown effects on reducing cocaine craving and consumption that are comparable to traditional high-frequency rTMS (15 Hz) in a study of 25 treatment-seeking cocaine addicts.
Both iTBS and 15 Hz rTMS demonstrated similar safety and tolerability profiles, with low dropout rates, suggesting that iTBS could be a more efficient treatment option due to its shorter duration (3 minutes) compared to the 15-minute standard protocol.
Intermittent Theta Burst Stimulation of the Prefrontal Cortex in Cocaine Use Disorder: A Pilot Study.Sanna, A., Fattore, L., Badas, P., et al.[2020]
Intermittent theta burst stimulation (iTBS) over the left DLPFC and continuous theta burst stimulation (cTBS) over the right DLPFC significantly reduced cue-induced craving in abstinent methamphetamine-dependent subjects, indicating their potential efficacy as treatments for addiction.
The study involved 83 participants and showed that while iTBS had higher self-reported adverse effects initially, both stimulation methods were feasible and tolerable, suggesting a promising approach to reduce craving with shorter treatment sessions.
Twice-Daily Theta Burst Stimulation of the Dorsolateral Prefrontal Cortex Reduces Methamphetamine Craving: A Pilot Study.Zhao, D., Li, Y., Liu, T., et al.[2023]
A proof-of-concept study involving 19 individuals with cocaine use disorder showed that administering intermittent theta-burst stimulation (iTBS) to the left dorsolateral prefrontal cortex was well-tolerated and safe, even in participants actively using cocaine.
Participants who completed at least 26 of the 30 iTBS sessions reduced their weekly cocaine use by 78% in spending and 70% in frequency, indicating that iTBS may effectively modulate addiction-related circuits and reduce substance use.
Accelerated Intermittent Theta-Burst Stimulation as a Treatment for Cocaine Use Disorder: A Proof-of-Concept Study.Steele, VR., Maxwell, AM., Ross, TJ., et al.[2020]

References

Intermittent Theta Burst Stimulation of the Prefrontal Cortex in Cocaine Use Disorder: A Pilot Study. [2020]
Twice-Daily Theta Burst Stimulation of the Dorsolateral Prefrontal Cortex Reduces Methamphetamine Craving: A Pilot Study. [2023]
Accelerated Intermittent Theta-Burst Stimulation as a Treatment for Cocaine Use Disorder: A Proof-of-Concept Study. [2020]
Intermittent Theta Burst Stimulation vs. High-Frequency Repetitive Transcranial Magnetic Stimulation in the Treatment of Methamphetamine Patients. [2022]
Role of maintenance treatment on long-term efficacy of bilateral iTBS of the prefrontal cortex in treatment-seeking cocaine addicts: A retrospective analysis. [2022]
Intermittent theta burst transcranial magnetic stimulation for methamphetamine addiction: A randomized clinical trial. [2021]
What goes up, can come down: Novel brain stimulation paradigms may attenuate craving and craving-related neural circuitry in substance dependent individuals. [2022]