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

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ClinicalTrials.gov Identifier: NCT05401929
Recruitment Status : Recruiting
First Posted : June 2, 2022
Last Update Posted : August 2, 2022
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Tonisha Kearney-Ramos, New York State Psychiatric Institute

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.


Condition or disease Intervention/treatment Phase
Cannabis Device: iTBS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Imaging the Effects of Intermittent Thetaburst Stimulation on Cannabis Self-Administration in Heavy Cannabis Users
Actual Study Start Date : June 1, 2022
Estimated Primary Completion Date : July 2027
Estimated Study Completion Date : July 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

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

Sham Comparator: Sham 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.




Primary Outcome Measures :
  1. 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).

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05401929


Contacts
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Contact: Tonisha Kearney-Ramos, PhD 646-774-6185 tonisha.kearney-ramos@nyspi.columbia.edu

Locations
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United States, New York
New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Contact: Tonisha Kearney-Ramos, PhD    646-774-6185    tonisha.kearney-ramos@nyspi.columbia.edu   
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Tonisha Kearney-Ramos, PhD New York State Psychiatric Institute
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Responsible Party: Tonisha Kearney-Ramos, Research Scientist III/Assistant Professor of Clinical Neurobiology (in Psychiatry), New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT05401929    
Other Study ID Numbers: 8152
1K01DA050691-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 2, 2022    Key Record Dates
Last Update Posted: August 2, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Tonisha Kearney-Ramos, New York State Psychiatric Institute:
cannabis
self administration
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
residential
inpatient
ecological momentary assessment
randomized controlled clinical trials
randomized clinical trials
neuronavigation
personalized cortical targeting
biomarker development
brain mapping
neuroendophenotypes
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders