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

NCT ID: NCT05401929

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2029-07-31

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 transcranial magnetic stimulation (TMS), 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.

This study will evaluate whether 2 weeks of rTMS can be used to decrease attentional bias to cannabis cues and reduce cannabis use in heavy cannabis users. We will recruit sixty (60) non-treatment seeking, near-daily cannabis users to receive 10 daily sessions of either real or sham (aka placebo) rTMS over a 2-week period. Participants will live on a residential research unit for 3 weeks. During the residential stay, data on cannabis use (measured using standard human laboratory measures of choice to smoke cannabis) and relevant brain activity (measured using drug cue exposure fMRI tasks) will be collected before and after the course of 10 daily rTMS sessions. We will aim to show whether real rTMS treatment reduces brain response and attentional bias to cannabis cues and reduces cannabis use levels.

Detailed Description

This study is pending transfer to Duke University.

Conditions

Cannabis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active

Group Type: EXPERIMENTAL

iTBS

Intervention Type: DEVICE

Six trains of active intermittent thetaburst stimulation (iTBS) using neuronavigation-guided cortical targeting to the left dorsolateral prefrontal cortex location using figure-of-8 TMS coils.

Sham

Group Type: SHAM_COMPARATOR

iTBS

Intervention Type: DEVICE

Six trains of sham intermittent thetaburst stimulation (iTBS) using neuronavigation-guided cortical targeting to the left dorsolateral prefrontal cortex location using figure-of-8 TMS coils.

Interventions

iTBS

Six trains of active intermittent thetaburst stimulation (iTBS) using neuronavigation-guided cortical targeting to the left dorsolateral prefrontal cortex location using figure-of-8 TMS coils.

Intervention Type: DEVICE

iTBS

Six trains of sham intermittent thetaburst stimulation (iTBS) using neuronavigation-guided cortical targeting to the left dorsolateral prefrontal cortex location using figure-of-8 TMS coils.

Intervention Type: DEVICE

Other Intervention Names

Repetitive transcranial magnetic stimulation; Patterned repetitive transcranial magnetic stimulation; rTMS; intermittent thetaburst stimulation; Intermittent theta burst stimulation; Intermittent theta-burst stimulation

Eligibility Criteria

Inclusion Criteria

• Males/non-pregnant females, 18-60 years old
• Current cannabis user
• Able to perform all study procedures

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Tonisha Kearney-Ramos, PhD

Research Scientist III/Assistant Professor of Clinical Neurobiology (in Psychiatry)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tonisha Kearney-Ramos, PhD

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute

Locations

New York State Psychiatric Institute

New York, New York, United States

Countries

United States

Other Identifiers

1K01DA050691-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

8152

Identifier Type: -

Identifier Source: org_study_id