Cannabis and Schizophrenia: Self-Medication and Agonist Treatment
Completed · Phase 1
Conditions studied: Schizophrenia, Dual Diagnosis, Schizoaffective Disorder, Psychotic Disorder, Cannabis Use Disorder
In brief
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.
Key facts
- Study ID
- NCT00946348
- Run by
- Dartmouth-Hitchcock Medical Center
- People needed
- 12
- Starts
- 2009-12-01
- Expected to finish
- 2012-10-01
- Last updated by the study team
- 2021-07-12
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 Study
- Exclusion criteria for normal control subjects:
- Axis I or Axis II psychiatric diagnosis (including substance use disorder) based on SCID
- Mental retardation;
- History of head injury with period of unconsciousness;
- Metal objects within the body;
- Pregnancy or currently nursing;
- Uncontrolled serious medical condition;
- Current tobacco smokers. Note: We exclude current tobacco smoking (but not a history of smoking) in the normal control subjects since the fact of cigarette smoking could select subjects with a dysregulated BRC as a basis for their continued cigarette smoking in the face of social conventions toward non-smoking.
Where it is running
- Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
Full record on ClinicalTrials.gov
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