Recruiting

rTMS

Sponsor:

Duke University

Code:

NCT05401929

Conditions

Cannabis

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

iTBS

iTBS

Study Details

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.

Conditions

Cannabis

Study ID

NCT05401929

Start date

Jun 1, 2022

Status verified date

Jan, 2026

Completion date

Jul, 2029

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active

sham comparator: Sham

Interventions

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.

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.

Primary outcome measure

  • Frequency of cannabis use [ Time Frame: Two-week Pre-treatment/Baseline phase (Days 1-14), Two-week Treatment phase (Days 15-28), Four-week Post-treatment phase (Days 29-56) ]
  • Quantity of cannabis use [ Time Frame: Two-week Pre-treatment/Baseline phase (Days 1-14), Two-week Treatment phase (Days 15-28), Four-week Post-treatment phase (Days 29-56) ]

Central Contacts and Locations

Central contacts

Locations

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27705

Contacts

More Information

Sponsor

Duke University

Last update posted

Jul 13, 2026

Last verified

Jan, 2026

Keywords

  • cannabis
  • transcranial magnetic stimulation
  • repetitive transcranial magnetic stimulation
  • intermittent theta burst stimulation
  • functional magnetic resonance imaging
  • functional neuroimaging
  • functional brain imaging
  • marijuana
  • cannabis smoking
  • marijuana smoking
  • recreational marijuana use
  • stroop task
  • attentional bias
  • drug cue reactivity
  • intervention
  • treatment
  • double blind
  • sham
  • sham controlled
  • ecological momentary assessment
  • randomized controlled clinical trials
  • randomized clinical trials
  • neuronavigation
  • personalized cortical targeting
  • biomarker development
  • brain mapping
  • neuroendophenotypes
  • neurobiomarkers
  • accelerated
  • functional connectivity
  • network
  • fmri

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-07-13.