Feasibility Trial of rTMS for Cannabis Use Disorder

NCT03538288 | Completed

• 1 other identifier: Pro00054706
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Cannabis

Outcome Measures

Primary Outcomes (1)

• 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.

  7 weeks

Study Arms (1)

Twenty sessions of rTMS

EXPERIMENTAL

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

Device: rTMS

Interventions

rTMS DEVICE

rTMS will be applied at 10 Hz to the DLPFC

Twenty sessions of rTMS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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-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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Marijuana Abuse

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Gregory Sahlem

  Instructor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2016
• First Posted: May 29, 2018
• Study Start: October 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: August 2, 2018

Record last verified: 2018-05

Locations

US (1)