rTMS Treatment for Cannabis Use Disorders in Psychosis

Psychosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03069612
• Other study ID #: 215/2016
• Status: Terminated
• Phase: N/A
• First received: February 22, 2017
• Last updated: September 6, 2017
• Start date: December 1, 2016
• Est. completion date: August 28, 2017

Study information

• Verified date: September 2017
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: August 28, 2017
• Est. primary completion date: August 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Cannabis Use Disorder
• Marijuana Abuse
• Mental Disorders
• Psychosis
• Psychotic Disorders

Intervention

Device:
• Repetitive Transcranial Magnetic Stimulation (rTMS)
rTMS administered bilaterally to the DLPFC at 20 Hz, 90% RMT, 25 trains

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Working Memory Performance	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.
Secondary	Gamma Oscillations	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.

External 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: