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

August 16, 2023 updated by: Tonisha Kearney-Ramos, New York State Psychiatric Institute

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

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • New York State Psychiatric Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active
Device: 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.
Other Names:
  • rTMS
  • Repetitive transcranial magnetic stimulation
  • Patterned repetitive transcranial magnetic stimulation
  • intermittent thetaburst stimulation
  • Intermittent theta burst stimulation
  • Intermittent theta-burst stimulation
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.
Sham Comparator: Sham
Device: 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.
Other Names:
  • rTMS
  • Repetitive transcranial magnetic stimulation
  • Patterned repetitive transcranial magnetic stimulation
  • intermittent thetaburst stimulation
  • Intermittent theta burst stimulation
  • Intermittent theta-burst stimulation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Cannabis self-administration (laboratory)
Time Frame: Baseline (Inpatient Day 3), approx. half-way (Inpatient Day 10), and 2 weeks (Inpatient Day 18)
During the inpatient phase, there will be three cannabis self-administration sessions: one 1 day before the intermittent thetaburst stimulation (iTBS) intervention begins, one on inpatient day 10, and one 1 day after the full 10-day course of iTBS treatment. On cannabis self-administration days, participants will be given 6 opportunities throughout the day at 1.5-h intervals (start at 9 am) to purchase 0-6 puffs of a cannabis cigarette from their study earnings, up to 36 puffs per day. For each participant, we will quantify the total number of puff choices (0-36) they made to self-administer cannabis on Inpatient Day 3 (baseline; 1 day before the iTBS treatment) and compare it to Inpatient Day 18 (follow-up; 1 day after the full course of iTBS treatment).
Baseline (Inpatient Day 3), approx. half-way (Inpatient Day 10), and 2 weeks (Inpatient Day 18)
Change in Salience Network drug cue reactivity [functional brain data during Cannabis Stroop functional magnetic resonance imaging (fMRI) task]
Time Frame: Baseline (Inpatient Day 2) and 2.5 weeks (Inpatient Day 19)
Relative brain activity to cannabis vs neutral visual stimuli will be assessed during the Cannabis Stroop fMRI task from the first (baseline) to the last (2.5 weeks) timepoint.
Baseline (Inpatient Day 2) and 2.5 weeks (Inpatient Day 19)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first cannabis use (outpatient)
Time Frame: Post-inpatient Outpatient Days 1 - 14
The outcome will be 'time to first use' of cannabis, which is the time latency (in days) until the first day that the participant endorses using cannabis during the post-inpatient outpatient EMA period (which occurs on Days 1-14 after inpatient discharge). Endorsing the use of cannabis is given by a participant responding "Yes" to the daily Yes/No prompts sent via mobile phone each evening at 10pm which ask if they have used cannabis that day/timeframe.
Post-inpatient Outpatient Days 1 - 14
Change in Frequency of cannabis use (outpatient)
Time Frame: Baseline (Pre-Inpatient) Outpatient Days 1 - 14 and Post-inpatient Outpatient Days 1 - 14
The outcome will be 'frequency of cannabis use,' which is the total number of days/week during the 2-week post-inpatient outpatient EMA period that a participant endorses using cannabis (by responding "Yes" to the daily evening mobile phone prompt asking them if they used cannabis that day; daily prompts occur on Days 1-14 after inpatient discharge. The frequency of use (total # of days/week used during the 2-week outpatient period) is computed independently for the pre-inpatient (baseline) and post-inpatient (follow-up) outpatient periods, and then the follow-up period is compared relative to baseline to get a measure of change following iTBS treatment.
Baseline (Pre-Inpatient) Outpatient Days 1 - 14 and Post-inpatient Outpatient Days 1 - 14
Change in Quantity of cannabis use (outpatient)
Time Frame: Baseline (Pre-Inpatient) Outpatient Days 1 - 14 and Post-inpatient Outpatient Days 1 - 14
The outcome will be 'quantity of cannabis use' which is the total number of grams during each 14-day outpatient period that a participant endorses using (by responding "Yes" to the mobile phone prompt asking them if they used cannabis that day, and then entering the quantity in the following mobile phone prompt asking them "How many total grams did you use?" The quantity (total # of grams used over the 14-day period) is computed independently for the pre-inpatient (baseline) and post-inpatient (follow-up) outpatient periods, then the follow-up period is compared relative to baseline.
Baseline (Pre-Inpatient) Outpatient Days 1 - 14 and Post-inpatient Outpatient Days 1 - 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Tonisha Kearney-Ramos, PhD, New York State Psychiatric Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2029

Study Registration Dates

First Submitted

May 27, 2022

First Submitted That Met QC Criteria

June 1, 2022

First Posted (Actual)

June 2, 2022

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 16, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8152
  • 1K01DA050691-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cannabis

Clinical Trials on iTBS

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe