Cannabis and Schizophrenia: Self-Medication and Agonist Treatment

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: Columbia University; Indiana University; National Institute on Drug Abuse (NIDA); University of Massachusetts, Worcester; University of Vermont
• Treatments: Dronabinol

Criteria

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 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.