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Feasibility Trial of rTMS for Cannabis Use Disorder

Primary Purpose

Cannabis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
rTMS
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Cannabis

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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-5 criteria for at least moderate Cannabis Use Disorder, with use of at least 20 / last 28 days.
  4. Participants must express a desire to quit cannabis.
  5. Participants must have a positive UDS for cannabis during their enrollment visit (confirming they are regular users).

Exclusion Criteria:

  1. Participants must not be pregnant or breastfeeding.
  2. Participants must not test positive for any substance other than cannabis on UDS during their enrollment visit.
  3. Participants must not meet moderate or severe use disorder of any other substance with the exception of Tobacco 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 or bipolar disorder.
  6. Participants must not have any other Axis I condition requiring current treatment and must have a HRSD24 ≤10 indicating no clinically relevant depressive symptoms.
  7. Participants must not have a history of dementia or other cognitive impairment.
  8. Participants must not have active suicidal ideation or a suicide attempt within the past 90 days.
  9. Participants must not have any contraindications to receiving rTMS (e.g. metal implanted above the head, history of seizure, any known brain lesion).
  10. Participants must not have any unstable general medical conditions.

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Twenty sessions of rTMS

Arm Description

Twenty sessions of rTMS will be applied to treatment seeking participants.

Outcomes

Primary Outcome Measures

Determine if a course of rTMS is feasible to deliver and well tolerated by a group of cannabis use disordered participants.
The investigators will test the hypothesis that at least 50% of enrolled participants will complete the trial.

Secondary Outcome Measures

Full Information

First Posted
September 7, 2016
Last Updated
July 31, 2018
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT03538288
Brief Title
Feasibility Trial of rTMS for Cannabis Use Disorder
Official Title
A Pilot Trial Determining the Feasibility of Delivering Twenty Treatments of Repetitive Transcranial Magnetic Stimulation (rTMS) to Treatment Seeking Cannabis Use Disordered Participants
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
July 1, 2017 (Actual)
Study Completion Date
July 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This small pilot trial will recruit 10 cannabis use disordered participants and apply 20 sessions of rTMS in conjunction with a two session Brief Marijuana Dependance Counseling treatment paradigm. The investigators are primarily seeking to determine if the proposed paradigm is feasible and well tolerated.
Detailed Description
The overarching goal of this proposal is to investigate if a course of excitatory DLPFC rTMS is feasible and well tolerated by a group of treatment seeking CUD patients (Aim1). The investigators are also hoping to preliminarily determine if a course of rTMS reduces cannabis cue-induced craving (Aim2). Additionally the investigators want to preliminarily explore the mechanistic underpinnings of any observed effect by collecting functional magnetic resonance imaging (fMRI) data during cannabis cue-administration before and after the treatment course (Aim 3). These aims will be addressed through an open label study in which 10 treatment seeking cannabis use disordered participants will be given 20 sessions of Active excitatory rTMS applied to the DLPFC. TMS will be delivered in an accelerated fashion over two weeks (2 sessions each day, five days each week). TMS will be applied in conjunction with a validated two-session Motivational Enhancement Therapy (MET) behavioral intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Twenty sessions of rTMS
Arm Type
Experimental
Arm Description
Twenty sessions of rTMS will be applied to treatment seeking participants.
Intervention Type
Device
Intervention Name(s)
rTMS
Intervention Description
rTMS will be applied at 10 Hz to the DLPFC
Primary Outcome Measure Information:
Title
Determine if a course of rTMS is feasible to deliver and well tolerated by a group of cannabis use disordered participants.
Description
The investigators will test the hypothesis that at least 50% of enrolled participants will complete the trial.
Time Frame
7 weeks

10. Eligibility

Sex
Female
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-5 criteria for at least moderate Cannabis Use Disorder, with use of at least 20 / last 28 days. Participants must express a desire to quit cannabis. Participants must have a positive UDS for cannabis during their enrollment visit (confirming they are regular users). Exclusion Criteria: Participants must not be pregnant or breastfeeding. Participants must not test positive for any substance other than cannabis on UDS during their enrollment visit. Participants must not meet moderate or severe use disorder of any other substance with the exception of Tobacco 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 or bipolar disorder. Participants must not have any other Axis I condition requiring current treatment and must have a HRSD24 ≤10 indicating no clinically relevant depressive symptoms. Participants must not have a history of dementia or other cognitive impairment. Participants must not have active suicidal ideation or a suicide attempt within the past 90 days. Participants must not have any contraindications to receiving rTMS (e.g. metal implanted above the head, history of seizure, any known brain lesion). Participants must not have any unstable general medical conditions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Sahlem
Organizational Affiliation
Instructor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Feasibility Trial of rTMS for Cannabis Use Disorder

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