Status:
COMPLETED
Cannabis and Schizophrenia: Self-Medication and Agonist Treatment
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Indiana University
Conditions:
Schizophrenia
Dual Diagnosis
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief 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 giv...
Detailed Description
Cannabis use disorder (CUD) is up to ten times more common in schizophrenia (SCZ) than in the general population, and substantially worsens the course of this severe psychiatric disorder. Since SCZ oc...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00946348
Start Date
December 1 2009
End Date
October 1 2012
Last Update
July 12 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756