Phase 1
N=12
Cannabis and Schizophrenia: Self-Medication and Agonist Treatment
Schizophrenia · Dual Diagnosis · Schizoaffective Disorder · Psychotic Disorder · Cannabis Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00946348 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcome: Primary: fMRI Connectivity of Regions of Interest (ROI) Within the Brain Reward Circuitry (BRC). — .40; .33 Z score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Dronabinol (Drug); Cannabis (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY fMRI Connectivity of Regions of Interest (ROI) Within the Brain Reward Circuitry (BRC). |
.40; .33 | — |
| SECONDARY To Assess the Effects of Dronabinol in This Population to Determine Whether Measures of Craving, Mood and Negative Symptoms Will Improve Using the PANSS; and to Determine Whether Measures of Psychotic Symptoms and Cognitive Deficits Will Increase. |
— | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00946348). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.