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CompletedNCT03538288Updated Aug 2, 2018

Feasibility Trial of rTMS for Cannabis Use Disorder

An interventional study of rTMS in Cannabis, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-08-02.

Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Device feasibility

Phase
Not applicable
Study type
Interventional
Enrollment
3
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Cannabis

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03

In context

Marijuana Abuse

517 studies on the registry are indexed under Marijuana Abuse; 114 are open to participants now.

This study's enrollment of 3 is below the median of 60 across 421 interventional studies indexed under Marijuana Abuse.

Browse Marijuana Abuse studies →

Lead sponsor

Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.

Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • Experimental
    Twenty sessions of rTMS

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

    Device: rTMS

Interventions

  • DevicerTMS

    rTMS will be applied at 10 Hz to the DLPFC

06

What researchers measure

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.

    Time frame: 7 weeks

07

Study locations

1 site
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03538288
Lead sponsor
Medical University of South Carolina
Responsible party
Sponsor
First posted
May 29, 2018
Start date
Oct 1, 2016
Primary completion
Jul 1, 2017
Completion
Jul 1, 2017
Last update
Aug 2, 2018

Study contacts

Gregory Sahlem
principal investigator · Instructor

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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