rTMS Treatment for Cannabis Use Disorders in Psychosis

NCT03069612 | Terminated

• 1 other identifier: 215/2016
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cannabis Use Disorder; Psychosis

Keywords

repetitive transcranial magnetic stimulation; working memory; gamma oscillations; dorsolateral prefrontal cortex

Outcome Measures

Primary Outcomes (1)

• Cannabis Abstinence

  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 Outcomes (2)

• Working Memory Performance

  Baseline, trial endpoint (Day 28) and at follow up (Day 56) for a total of 3 times.

• Gamma Oscillations

  Baseline, trial endpoint (Day 28) and at follow up (Day 56) for a total of 3 times.

Study Arms (2)

rTMS Active Group

EXPERIMENTAL

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 Sham Group

SHAM COMPARATOR

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)

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS) DEVICE

rTMS administered bilaterally to the DLPFC at 20 Hz, 90% RMT, 25 trains

rTMS Active Group; rTMS Sham Group

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5S2S1, Canada

Location

Related Links

• Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital, fully affiliated with the University of Toronto, and a PAHO/WHO Collaborating CentreStudy Data/Documents:

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Mera S Barr, PhD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Independent Scientist

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: March 3, 2017
• Study Start: December 1, 2016
• Primary Completion: August 28, 2017
• Study Completion: August 28, 2017
• Last Updated: September 11, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)