Cannabis and Schizophrenia: Self-Medication and Agonist Treatment (NCT00946348) | Clinical Trial Compass
CompletedPhase 1
Cannabis and Schizophrenia: Self-Medication and Agonist Treatment
United States12 participantsStarted 2009-12
Plain-language summary
The first aim of this study is to determine whether a brain reward center (BRC) deficiency in patients with schizophrenia (SCZ) and cannabis use disorder (CUD) will be normalized when patients are given cannabis or dronabinol. The second aim will serve to further assess the effects of dronabinol on symptoms and medication side effects in this population.
Who can participate
Age range18 Years – 50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Inclusion criteria for study subjects (dual diagnosis patients):
* Age 18-50;
* Diagnosis of schizophrenia or schizoaffective disorder (by SCID)
* Diagnosis of current cannabis abuse or dependence (by SCID);
* Recent use of cannabis (within the past month on Timeline Follow-Back);
* Stability on antipsychotic medication for past 1 month);
* Outpatient status for past 3 months;
* Willing and able to participate as demonstrated by a signed informed consent document.
Inclusion criteria for normal control subjects:
* Age 18-50;
* Willing to participate as demonstrated by a signed informed consent document
Exclusion Criteria:
Exclusion criteria for study subjects (dual diagnosis patients):
* PANSS subscale for positive symptoms of psychosis item \> 3 \[moderate\] on Day 15 (once they are abstinent from cannabis);
* Cocaine/stimulant use disorder;
* Pharmacological treatment for addiction (e.g., disulfiram, naltrexone, acamprosate, topiramate); Mental retardation;
* Pregnancy or currently nursing;
* Uncontrolled serious medical condition;
* Seizure disorder
* Seeking treatment to limit their cannabis use
* Taking clozapine
Additional Exclusion criteria for Main Study patients only:
* Claustrophobia prohibiting scanning
* History of head injury with period of unconsciousness;
* Metal objects within the body;
* Taking antipsychotic other than risperidone or first generation antipsychotic as main treatment
* Previous participation in the Pilot Dose Finding…
What they're measuring
1
fMRI Connectivity of Regions of Interest (ROI) Within the Brain Reward Circuitry (BRC).
Timeframe: Measures were acquired at peak THC level for each of the two drugs up to 4 hours.