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

NCT05401929 | Suspended FDA Device

• 2 other identifiers: Pro00118090K01DA050691
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (2)

• Frequency of cannabis use

  On each study day, participants will receive EMA text surveys on their cellphones. For each participant, cannabis use frequency will be measured as the number of days per week they report cannabis use. During the two-week pre-treatment period, we will calculate the baseline frequency as the average number of use days per week across those two weeks. Cannabis use frequency will then be assessed during each of the two treatment weeks (Week 0-1) and during the four-week follow-up period (Weeks 2-5), and the follow-up period will subsequently be compared relative to baseline. This is corroborated by TLFB.

  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

  On each study day, participants will receive EMA text surveys on their cellphones. For each participant, cannabis use quantity will be measured as the average number of grams used per use-day during each week in which they report cannabis use. During the two-week pre-treatment/baseline period (Days 1-14), we will calculate the baseline quantity as the average daily grams used per use-day across those two weeks. Cannabis use quantity will then be assessed during the treatment phase (Days 15-28) and during the 4-week follow-up period (Days 29-56), and the follow-up period will subsequently be compared relative to baseline. This will be corroborated by TLFB.

  Two-week Pre-treatment/Baseline phase (Days 1-14), Two-week Treatment phase (Days 15-28), Four-week Post-treatment phase (Days 29-56)

Secondary Outcomes (4)

• Salience Network drug cue reactivity

  Pre-treatment/Baseline (Day 14), Immediate Post-treatment (Day 28), 4-Week Post-treatment Follow-up (Day 56)

• Feasibility (attendance)

  Two-week Treatment phase (Days 15-28)

• Tolerability (withdrawals)

  Two-week Treatment phase (Days 15-28)

• Safety (AEs)

  Two-week Treatment phase (Days 15-28)

Study Arms (2)

Active

EXPERIMENTAL

Device: iTBS

Sham

SHAM COMPARATOR

Device: iTBS

Interventions

iTBS DEVICE

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.

Also known as: Repetitive transcranial magnetic stimulation, Patterned repetitive transcranial magnetic stimulation, rTMS, intermittent thetaburst stimulation, Intermittent theta burst stimulation, Intermittent theta-burst stimulation, accelerated, accelerated iTBS, accelerated rTMS

Active

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males/non-pregnant females, 18-65 years old
• Current cannabis user
• Able to perform all study procedures

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Marijuana Abuse; Marijuana Smoking; Marijuana Use

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior; Smoking, Non-Tobacco Products; Smoking

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Tonisha Kearney-Ramos, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: June 2, 2022
• Study Start: June 1, 2022
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2029
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)