The blinded CLOZ will be titrated on a recommended standard schedule, supervised by a study physician (or other prescriber) who can make the necessary adjustments to account for symptom control and tolerability. The titration is recommended to begin at 12.5 mg and then increase while the open-label base antipsychotic is tapered with a recommended goal of decreasing the base antipsychotic by 25% each week. If clinically tolerated, the target dose of CLOZ is 400 mg/day.

The blinded RISP will also be titrated in the first weeks, using a titration schedule, with a target dose of 4 mg/day, while the open label base antipsychotic is tapered in a similar fashion.

The blinded CLOZ will be titrated on a recommended standard schedule, supervised by a study physician (or other prescriber) who can make the necessary adjustments to account for symptom control and tolerability. The titration is recommended to begin at 12.5 mg and then increase while the open-label base antipsychotic is tapered with a recommended goal of decreasing the base antipsychotic by 25% each week. If clinically tolerated, the target dose of CLOZ is 400 mg/day.
Clozapine: Clozapine: target dose of 400mg per day with a maximum dose of 550mg per day

Clozapine

The blinded RISP will also be titrated in the first weeks, using a titration schedule, with a target dose of 4 mg/day, while the open label base antipsychotic is tapered in a similar fashion.
Risperidone: Clozapine: target dose of 4mg per day with a maximum dose of 6mg per day

Risperidone

Total

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

Intensity of cannabis use is obtained each week retrospectively as the number of joints smoked during the prior week (assessed using the Timeline Followback). Mixed models are used to obtain estimates of efficacy from the partial data provided by each subject while adherent to assigned treatment (under the 'missing at random' assumption). The 'explanatory' estimands (target of the mixed model estimation) are defined in terms of population quantities that would have occurred had all subjects remained on assigned treatment throughout the study. The point estimate for each arm is reported under Number.

Average Over Time of Intensity of Cannabis Use (Used to Evaluate Treatment Efficacy)

Frequency of cannabis use is obtained each week retrospectively as the number of days of cannabis use during the prior week (assessed using the Timeline Followback). Mixed models are used to obtain estimates of efficacy from the partial data provided by each subject while adherent to assigned treatment (under the 'missing at random' assumption). The 'explanatory' estimands (target of the mixed model estimation) are defined in terms of population quantities that would have occurred had all subjects remained on assigned treatment throughout the study. The point estimate for each arm is reported under Number.

Average Over Time of Frequency of Cannabis Use

Overall Study

Dr. Mary Brunette

Schizophrenia

Cannabis Abuse

Cannabis Dependence

Dual Diagnosis

Clozapine: target dose of 400mg per day with a maximum dose of 550mg per day

Clozapine: target dose of 4mg per day with a maximum dose of 6mg per day

CNS Network Inc

Pacific Research Partners

University of Miami

Unversity of Massachusetts Medical School

Michigan State University / Cherry Street Health Services

Dartmouth Hitchcock Medical Center

University of North Carolina/UNC Center for Excellence in Community Mental Health

University of South Carolina

Rutland Regional Medical Center

Clozapine for Cannabis Use in Schizophrenia

Clozapine for Cannabis Use Disorder in Schizophrenia

Alan Green

Principal Investigator

Dartmouth-Hitchcock Medical Center

Michigan State University

University of Massachusetts, Worcester

Carriers of high activity COMT158Val allele who are expected to show higher THC-induced meso-limbic DA release

Carriers of low activity COMT 158Met homozygotes are expected to release low amount of dopamine after smoking a cigarette with THC

Samples of DNA will be taken from saliva of participants

Psychosis

Hadassah Medical Organization, Jerusalem, Israel

The Pharmaco-genetic and Brain Mechanisms Associated With Cannabis- Induced Psychosis

DNA will be extracted from saliva of participants. Genetic variations of DA, GABA, glutamate and cannabis receptor CB1 will be coded.

Participants will be studied in a brain imaging study using [C 11] raclopride radioligand in Positron Emission Tomography (PET). Measures of D2 receptor occupancy will be taken at baseline and after smoking a cigarette containing 15 mg THC.

VEINSHTEIN AVIV

Senior Research Fellow

Hadassah Medical Organization

N-acetylcystein and placebo doses will be increased if craving decreases <25% compared to the previous visit. The doses start at 200 mg x 4/24h to 800 mg x 4/24h

Visit 1: Consent signed. Blood and urine analysis. Questionnaires assessing cannabis and tobacco's craving.N-acetylcystein and placebo doses will be increased if craving decreases <25% compared to previous visit.The doses start at 200 mg x 4/24h to 800 mg x 4/24h.Visit 2 to 5: Medication safety and cannabis craving and withdrawal assessment during 4 weeks.

N-acetylcystein

Service de Psychiatrie - Hôpital Lariboisière

Clinical Trial of N-acetylcysteine Versus Placebo Efficacy in the Cannabis Withdrawal

Randomized and Double-blind Clinical Trial of N-acetylcysteine Versus Placebo Efficacy in the Cannabis Withdrawal

Declarative clinical criteria by the patient and validated at D28 by the decrease of at least 50% of the report of the dosage of the report CarboxyTHC / creatinine

The amount of cannabis and THC consumed with use of the upper quartile to define a high consumption and the lowest quartile to define the weak consumer
Dependence and abuse according to DSM IV criteria;
Withdrawal syndrome in dependent patients according to DSM IV and the scale of MJQQ Gorelick.

catechol/marihuana

Clozapine for Cannabis Use in Schizophrenia

The Pharmaco-genetic and Brain Mechanisms Associated With Cannabis- Induced Psychosis

Clinical Trial of N-acetylcysteine Versus Placebo Efficacy in the Cannabis Withdrawal

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