Excitatory rTMS to the Left Dorsolateral Pre-Frontal Cortex to Reduce Cannabis-Cue Induced Craving
A Double Blind, Sham Controlled Trial of Excitatory rTMS to the Left Dorsolateral Pre-Frontal Cortex to Reduce Cannabis-Cue Induced Craving and Impulsive Decision Making in Cannabis Use Disordered Participants.
1 other identifier
interventional
18
0 countries
N/A
Brief Summary
This is a double-blind, crossover trial that will recruit a cohort of non-treatment seeking Cannabis use disordered participants. Participants will then undergo either active, or sham rTMS to the LDLPFC, and cue-induced craving, and risky decision making will be assessed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2015
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedFirst Posted
Study publicly available on registry
October 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedAugust 2, 2018
May 1, 2018
5 months
October 1, 2015
July 31, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Marijuana Craving Questionnaire (MCQ)
The MCQ will be given before and after a marijuana-cue paradigm, and the primary outcome will be the change score from pre to post.
15 Minutes
Secondary Outcomes (1)
The Balloon Aptitude Response Task (BART)
30 Minutes
Study Arms (2)
Active rTMS
EXPERIMENTALActive rTMS will be delivered to the Left DLPFC at 10Hz. A total of 4000 pulses will be delivered.
Sham rTMS
SHAM COMPARATORSham rTMS will be delivered to the Left DLPFC at 10 Hz using an electronic sham system used in multiple other investigations. A total of 4000 pulses of sham rTMS will be delivered.
Interventions
rTMS will be delivered at 110% rMT to the Left DLPFC with 5 seconds on, 10 seconds off for 4000 pulses.
rTMS will be delivered via an electronic sham coil that mimics real rTMS in appearance, sound, and feeling. Pulses will be delivered to the Left DLPFC with 5 seconds on, 10 seconds off for 4000 pulses.
Eligibility Criteria
You may qualify if:
- Participants must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
- Participants must be between the ages of 18 and 60.
- Participants must meet DSM-V criteria for Cannabis Use Disorder, with use of at least 20 days/month.
- Participants must agree to abstinence from Cannabis for at least 24 hours prior to each visit.
- Participants must have a Positive UDS for cannabis (confirming they are regular users), and a negative salivary cannabis test (Confirming no use within 10-14 hours)
You may not qualify if:
- Participants must not be pregnant and participate in the study.
- Participants must not test positive for any substance other than cannabis on UDS.
- Participants must not meet criteria for any other Substance Use Disorders with the exception of Nicotine Use Disorder.
- Participants must not be on any medications that have central nervous system effects.
- Participants Must not have a history of/or current Psychotic disorder.
- Participants must not have a history of Dementia or other cognitive impairment.
- Participants must not have active suicidal ideation, or suicide attempt within the past 90 days.
- Participants must not have any contraindications to receiving rTMS as assessed by the TMS safety sheet.
- Participants must not have any unstable general medical conditions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gregory Sahlem, MD
MUSC department of psychiatry
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2015
First Posted
October 2, 2015
Study Start
October 1, 2015
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
August 2, 2018
Record last verified: 2018-05