Excitatory rTMS to the Left Dorsolateral Pre-Frontal Cortex to Reduce Cannabis-Cue Induced Craving

July 31, 2018 updated by: Medical University of South Carolina

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Participants must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
  2. Participants must be between the ages of 18 and 60.
  3. Participants must meet DSM-V criteria for Cannabis Use Disorder, with use of at least 20 days/month.
  4. Participants must agree to abstinence from Cannabis for at least 24 hours prior to each visit.
  5. 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:

  1. Participants must not be pregnant and participate in the study.
  2. Participants must not test positive for any substance other than cannabis on UDS.
  3. Participants must not meet criteria for any other Substance Use Disorders with the exception of Nicotine Use Disorder.
  4. Participants must not be on any medications that have central nervous system effects.
  5. Participants Must not have a history of/or current Psychotic disorder.
  6. Participants must not have a history of Dementia or other cognitive impairment.
  7. Participants must not have active suicidal ideation, or suicide attempt within the past 90 days.
  8. Participants must not have any contraindications to receiving rTMS as assessed by the TMS safety sheet.
  9. Participants must not have any unstable general medical conditions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active rTMS
Active rTMS will be delivered to the Left DLPFC at 10Hz. A total of 4000 pulses will be delivered.
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
rTMS will be delivered at 110% rMT to the Left DLPFC with 5 seconds on, 10 seconds off for 4000 pulses.
Sham Comparator: Sham rTMS
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.
Device: Sham Repetitive Transcranial Magnetic Stimulation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Marijuana Craving Questionnaire (MCQ)
Time Frame: 15 Minutes
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Balloon Aptitude Response Task (BART)
Time Frame: 30 Minutes
The BART will be given pre, and post rTMS. Number of corrected pumps, and number of burst balloons will be collected.
30 Minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Investigators

  • Principal Investigator: Gregory Sahlem, MD, MUSC department of psychiatry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

October 1, 2015

First Submitted That Met QC Criteria

October 1, 2015

First Posted (Estimate)

October 2, 2015

Study Record Updates

Last Update Posted (Actual)

August 2, 2018

Last Update Submitted That Met QC Criteria

July 31, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00047358

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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