rTMS Treatment for Cannabis Use Disorders in Psychosis

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Rėmėjai

Centre for Addiction and Mental Health

KLINIKINIS TYRIMAS: NCT03069612

BioSeek: NCT03069612

Raktažodžiai

Santrauka

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.

apibūdinimas

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.

Datos

Paskutinį kartą patikrinta:	08/31/2017
Pirmasis pateikimas:	02/21/2017
Numatytas registravimas pateiktas:	02/26/2017
Pirmas paskelbtas:	03/02/2017
Paskutinis atnaujinimas pateiktas:	09/05/2017
Paskutinis atnaujinimas paskelbtas:	09/10/2017
Faktinė studijų pradžios data:	11/30/2016
Numatoma pirminio užbaigimo data:	08/27/2017
Numatoma studijų užbaigimo data:	08/27/2017

Būklė ar liga

Cannabis Use Disorder

Psychosis

Intervencija / gydymas

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Fazė

Rankų grupės

Ranka	Intervencija / gydymas
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.
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.

Tinkamumo kriterijai

Amžius, tinkami studijuoti	16 Years Į 16 Years
Tinkamos studijoms lytys	All
Priima sveikus savanorius	Taip
Kriterijai	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

Rezultatas

Pirminės rezultatų priemonės

1. Cannabis Abstinence [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.

Antrinės rezultatų priemonės

1. Working Memory Performance [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.

2. Gamma Oscillations [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.