Back to resultsExcitatory rTMS to the Left Dorsolateral Pre-Frontal Cortex to Reduce Cannabis-Cue Induced Craving
Primary Purpose
Cannabis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation (rTMS)
Sham Repetitive Transcranial Magnetic Stimulation
Sponsored by
About this trial
This is an interventional basic science trial for Cannabis focused on measuring Cannabis, rTMS, Craving, Decision making
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Active rTMS
Sham rTMS
Arm Description
Active rTMS will be delivered to the Left DLPFC at 10Hz. A total of 4000 pulses will be delivered.
Sham 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
The Balloon Aptitude Response Task (BART)
The BART will be given pre, and post rTMS. Number of corrected pumps, and number of burst balloons will be collected.
Full Information
NCT ID
NCT02567344
First Posted
October 1, 2015
Last Updated
July 31, 2018
Sponsor
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT02567344
Brief Title
Excitatory rTMS to the Left Dorsolateral Pre-Frontal Cortex to Reduce Cannabis-Cue Induced Craving
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Our primary aims are to determine the effect of a single session of 10 Hz L DLPFC rTMS on cannabis cue induced craving (Aim1), and behavioral tasks of impulsive decision making (Aim2), in non-treatment seeking individuals with Cannabis Use Disorder. The aims of the study will be accomplished by performing a double-blind, sham-controlled crossover trial. Non-Treatment seeking individuals with CUD will be recruited through media advertisements, as well as via a pre-established database of non-treatment seeking individuals who have participated in previous Cannabis trials and agreed to be re-contacted. Interested individuals will undergo a brief phone screen to determine if they meet general inclusion/exclusion criteria, and if so will be invited to meet with study personnel in order to sign informed consent, and undergo a screening visit. There will then be two experimental visits separated by at least one week. During each of these visits participants will undergo either a real, or sham rTMS treatment, as well as a cannabis cue Paradigm. Data on craving as well as on impulsive decision making will be collected before and after each treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis
Keywords
Cannabis, rTMS, Craving, Decision making
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active rTMS
Arm Type
Experimental
Arm Description
Active rTMS will be delivered to the Left DLPFC at 10Hz. A total of 4000 pulses will be delivered.
Arm Title
Sham rTMS
Arm Type
Sham Comparator
Arm Description
Sham 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.
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation (rTMS)
Intervention Description
rTMS will be delivered at 110% rMT to the Left DLPFC with 5 seconds on, 10 seconds off for 4000 pulses.
Intervention Type
Device
Intervention Name(s)
Sham Repetitive Transcranial Magnetic Stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Marijuana Craving Questionnaire (MCQ)
Description
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.
Time Frame
15 Minutes
Secondary Outcome Measure Information:
Title
The Balloon Aptitude Response Task (BART)
Description
The BART will be given pre, and post rTMS. Number of corrected pumps, and number of burst balloons will be collected.
Time Frame
30 Minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Sahlem, MD
Organizational Affiliation
MUSC department of psychiatry
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Excitatory rTMS to the Left Dorsolateral Pre-Frontal Cortex to Reduce Cannabis-Cue Induced Craving
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