NCT05401929 Transcranial Magnetic Brain Stimulation to Reduce Cannabis Use in Heavy Cannabis Users
| NCT ID | NCT05401929 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | Cannabis |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2022-06-01 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2022-06-01 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The growing legalization of cannabis across the U.S. is associated with increases in cannabis use, and accordingly, an increase in the number of individuals with cannabis use problems, including cannabis use disorder (CUD). While there are several medications being investigated as treatment options for CUD, none have been FDA-approved, and there is limited efficacy of traditional behavioral therapy approaches for this population. Consequently, there is a pressing need for the development of new treatments, including approaches that specifically target the brain areas associated with problematic cannabis use behaviors. Elevated attention to drug cues is one of the primary causes of relapse in heavy cannabis users. Preliminary data suggests that repetitive transcranial magnetic stimulation (rTMS), a non-invasive form of brain stimulation, may be a novel brain-based tool to decrease heightened attention to drug cues in people with CUD. Building on prior data, the primary goal of this study is to evaluate the feasibility and effectiveness of TMS as a tool to decrease attention to drug cues and reduce cannabis use. In this study, fifty (50) treatment-seeking, near-daily cannabis users will be recruited to receive either active or sham (placebo) repetitive TMS (rTMS). Participants will complete a total of 25 treatment sessions, delivered as five sessions per day across five days, with sessions flexibly scheduled over a two-week period. Measures of cannabis use and brain activity will be collected before and after treatment using real-time self-report assessments and functional magnetic resonance imaging (fMRI), respectively. Specifically, cannabis use will be assessed in participants' everyday environments using brief text-message surveys during a two-week baseline period, the two-week treatment period, and a four-week follow-up period. The study aims to determine whether active rTMS reduces brain activity in response to cannabis cues, decreases automatic attention to cannabis cues, and leads to meaningful reductions in cannabis use compared to sham treatment.
Eligibility Criteria
Inclusion Criteria: * Males/non-pregnant females, 18-65 years old * Current cannabis user * Able to perform all study procedures Exclusion Criteria: * Regular use of other illicit drugs * If medical history, physical and psychiatric examination, or laboratory tests performed during the screening process reveal any significant illness that the study physician deems contraindicated for study participation
Contact & Investigator
Tonisha Kearney-Ramos, PhD
PRINCIPAL INVESTIGATOR
Duke University
Frequently Asked Questions
Who can join the NCT05401929 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Cannabis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05401929 currently recruiting?
Yes, NCT05401929 is actively recruiting participants. Contact the research team at tonisha.kearney-ramos@duke.edu for enrollment information.
Where is the NCT05401929 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT05401929 clinical trial?
NCT05401929 is sponsored by Duke University. The principal investigator is Tonisha Kearney-Ramos, PhD at Duke University. The trial plans to enroll 50 participants.