Clinical trial NCT05401929: Transcranial Magnetic Brain Stimulation to Reduce Cannabis Use in Heavy Cannabis Users
Official title: Imaging the Effects of Intermittent Thetaburst Stimulation on Cannabis Self-Administration in Heavy Cannabis Users
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Cannabis
Keywords: 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
neurobiomarkers
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2022-06-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Cannabis self-administration (laboratory)
timeFrame: Baseline (Inpatient Day 3), approx. half-way (Inpatient Day 10), and 2 weeks (Inpatient Day 18)
measure: Change in Salience Network drug cue reactivity [functional brain data during Cannabis Stroop functional magnetic resonance imaging (fMRI) task]
timeFrame: Baseline (Inpatient Day 2) and 2.5 weeks (Inpatient Day 19)
Secondary outcomes:
measure: Time to first cannabis use (outpatient)
timeFrame: Post-inpatient Outpatient Days 1 - 14
measure: Change in Frequency of cannabis use (outpatient)
timeFrame: Baseline (Pre-Inpatient) Outpatient Days 1 - 14 and Post-inpatient Outpatient Days 1 - 14
measure: Change in Quantity of cannabis use (outpatient)
timeFrame: Baseline (Pre-Inpatient) Outpatient Days 1 - 14 and Post-inpatient Outpatient Days 1 - 14
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Tonisha Kearney-Ramos, PhD
role: PRINCIPAL_INVESTIGATOR
References: