iTBS for Cannabis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
New York State Psychiatric Institute, New York, NY
Cannabis+1 More
iTBS - Device
Eligibility
18 - 65
All Sexes
What conditions do you have?
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Study 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.

Eligible Conditions

  • Cannabis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: Baseline (Inpatient Day 3), approx. half-way (Inpatient Day 10), and 2 weeks (Inpatient Day 18)

Week 5
Change in Salience Network drug cue reactivity [functional brain data during Cannabis Stroop functional magnetic resonance imaging (fMRI) task]
Week 2
Change in Cannabis self-administration (laboratory)
Day 1
Change in Frequency of cannabis use (outpatient)
Change in Quantity of cannabis use (outpatient)
Day 1
Time to first cannabis use (outpatient)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Active
1 of 2
Sham
1 of 2
Experimental Treatment
Non-Treatment Group

40 Total Participants · 2 Treatment Groups

Primary Treatment: iTBS · Has Placebo Group · N/A

Active
Device
Experimental Group · 1 Intervention: iTBS · Intervention Types: Device
Sham
Device
ShamComparator Group · 1 Intervention: iTBS · Intervention Types: Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
iTBS
2018
Completed Phase 3
~530

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (inpatient day 3), approx. half-way (inpatient day 10), and 2 weeks (inpatient day 18)
Closest Location: New York State Psychiatric Institute · New York, NY
Photo of New York 1Photo of New York 2Photo of New York 3
2001First Recorded Clinical Trial
4 TrialsResearching Cannabis
212 CompletedClinical Trials

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,201 Previous Clinical Trials
5,610,114 Total Patients Enrolled
17 Trials studying Cannabis
1,511 Patients Enrolled for Cannabis
New York State Psychiatric InstituteLead Sponsor
453 Previous Clinical Trials
135,968 Total Patients Enrolled
3 Trials studying Cannabis
36 Patients Enrolled for Cannabis
Tonisha Kearney-Ramos, PhDPrincipal InvestigatorNew York State Psychiatric Institute

Eligibility Criteria

Age 18 - 65 · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are male or female, aged 18 to 60 years.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.