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RECRUITING
NCT05401929
NA

Transcranial Magnetic Brain Stimulation to Reduce Cannabis Use in Heavy Cannabis Users

Sponsor: Duke University

View on ClinicalTrials.gov

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.

Official title: Imaging the Effects of Intermittent Thetaburst Stimulation on Cannabis Self-Administration in Heavy Cannabis Users

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2022-06-01

Completion Date

2029-07

Last Updated

2026-07-13

Healthy Volunteers

Yes

Conditions

Interventions

DEVICE

iTBS

Sixty trains of active intermittent thetaburst stimulation (iTBS) (1 train = 10 sec of 2 sec ON, 8 sec OFF; 3-pulse bursts at 5 Hz; 15 pulses/sec \[30 pulses/train\]; 60 trains/session; 1,800 pulses/session) using neuronavigation-guided cortical targeting to the left dorsolateral prefrontal cortex location using figure-of-8 TMS coils.

DEVICE

iTBS

Sixty trains of sham intermittent thetaburst stimulation (iTBS) (1 train = 10 sec of 2 sec ON, 8 sec OFF; 3-pulse bursts at 5 Hz; 15 pulses/sec \[30 pulses/train\]; 60 trains/session; 1,800 pulses/session) using neuronavigation-guided cortical targeting to the left dorsolateral prefrontal cortex location using figure-of-8 TMS coils.

Locations (1)

Duke University Medical Center

Durham, North Carolina, United States