rTMS Treatment for Cannabis Use Disorders in Psychosis

September 6, 2017 updated by: Mera Barr, Centre for Addiction and Mental Health

Evaluating Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Cannabis Dependence and Working Memory in Patients With Early Psychosis

Cannabis use during adolescence represents a significant risk factor for the development of psychosis including schizophrenia. Moreover, cannabis is the most commonly used drug among patients with an existing psychotic disorder. An estimated 25% of patients with psychosis reportedly meet the criteria of a cannabis use disorder particularly among younger patients experiencing their first episode. Cannabis use significantly exacerbates symptomatology resulting in an increased duration of the first hospitalization visit, number of hospital readmissions, and overall reduced functional outcome. Discovering novel strategies to treat the underlying pathophysiology of cannabis dependence early in the disorder may translate into improved functional outcome. Working memory deficits have been shown to predict relapse in the first-year of psychosis and is modulated with cannabis use. Repetitive transcranial magnetic stimulation (rTMS) targeted to the dorsolateral prefrontal cortex (DLPFC) has shown tremendous promise for the treatment of both tobacco dependence and working memory impairment in patients with psychosis possibly through the modulation of gamma (30-50 Hz) oscillations. The proposed study will therefore evaluate the effect of rTMS on abstinence, working memory performance, and gamma oscillations through a randomized, double-blind, placebo-controlled 28-day longitudinal abstinence study design in patients with early psychosis. It will further explore if baseline performance and gamma oscillations predict abstinence in response to rTMS. It is hypothesized that active compared to sham rTMS will improve abstinence rates and improve working memory performance through the modulation of gamma oscillations.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This a randomized, double-blind placebo-controlled, longitudinal 28-Day abstinence study design. Patients with psychosis will be randomized (1:1) to receive either active or sham stimulation that will be administered three times per week for 4 weeks (28 days) for a total of 12 treatments. Urine will be collected three times per week prior to the rTMS treatment. Cognition including the N-Back task and MATRICS cognitive battery will be administered on Day 0, Day 28, and Day 42 to determine the effect of rTMS on cognition compared to sham stimulation.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5S2S1
        • Centre for Addiction and Mental Health

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

16 years to 35 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 16-35
  • Meet Diagnostic and Statistical Manual for Mental Disorders (DSM)-5 diagnostic criteria for a cannabis use disorder with physiological evidence of dependence; plus one of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, bipolar I disorder, major depressive disorder with psychotic features, cannabis-induced psychosis, or psychosis not otherwise specified
  • Full scale IQ ≥ 80 determined through the Wechler Test for Adult Reading (WTAR)
  • Daily cigarette smoker of ≥ 5 cigarettes per day

Exclusion Criteria:

  • DSM-5 diagnoses of alcohol, substance or poly-use substance use disorder in the past 6 months (other than cannabis/caffeine or nicotine)
  • Currently active suicidal ideation or self-harm (suicidal or non-suicidal)
  • Head injury resulting in loss of consciousness and hospitalization
  • Major neurological or medical illness including seizure disorder or syncope
  • Metallic implants
  • History of rTMS treatment
  • Pregnancy

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: rTMS Active Group
Repetitive transcranial magnetic stimulation (rTMS) will be administered bilaterally to the dorsolateral prefrontal cortex (DLPFC) at 20 Hz, 90% RMT in 25 trains.
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
rTMS administered bilaterally to the DLPFC at 20 Hz, 90% RMT, 25 trains
SHAM_COMPARATOR: rTMS Sham Group
Repetitive transcranial magnetic stimulation (rTMS) will be administered bilaterally to the dorsolateral prefrontal cortex (DLPFC) at 20 Hz, 90% RMT in 25 trains with a sham coil.
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
rTMS administered bilaterally to the DLPFC at 20 Hz, 90% RMT, 25 trains

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cannabis Abstinence
Time Frame: Change of COOH and creatinine concentrations.from baseline to Day 28.
Gas chromatography/mass spectrometry (GC/MS) analysis to obtain quantitative THC-COOH and creatinine concentrations.
Change of COOH and creatinine concentrations.from baseline to Day 28.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Working Memory Performance
Time Frame: Baseline, trial endpoint (Day 28) and at follow up (Day 56) for a total of 3 times.
Working memory task will measure accuracy and reaction time.
Baseline, trial endpoint (Day 28) and at follow up (Day 56) for a total of 3 times.
Gamma Oscillations
Time Frame: Baseline, trial endpoint (Day 28) and at follow up (Day 56) for a total of 3 times.
Oscillatory activity will be measured through EEG while performing the working memory task.
Baseline, trial endpoint (Day 28) and at follow up (Day 56) for a total of 3 times.

Collaborators and Investigators

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

Sponsor

Centre for Addiction and Mental Health

Investigators

  • Principal Investigator: Mera S Barr, PhD, Centre for Addiction and Mental Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

December 1, 2016

Primary Completion (ACTUAL)

August 28, 2017

Study Completion (ACTUAL)

August 28, 2017

Study Registration Dates

First Submitted

February 22, 2017

First Submitted That Met QC Criteria

February 27, 2017

First Posted (ACTUAL)

March 3, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 11, 2017

Last Update Submitted That Met QC Criteria

September 6, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 215/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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