Cannabis, Schizophrenia and Reward: Self-Medication and Agonist Treatment? (NCT01964404) | Clinical Trial Compass
CompletedPhase 1
Cannabis, Schizophrenia and Reward: Self-Medication and Agonist Treatment?
United States263 participantsStarted 2014-07
Plain-language summary
In this translational research proposal, based on our formulation, we seek to confirm and expand upon data obtained in our pilot study suggesting that cannabis and the cannabinoid agonist dronabinol, given in low dose to patients with schizophrenia and co-occurring cannabis use disorder, will in fact ameliorate the brain reward circuit dysregulation in these patients and, thereby, provide evidence in support of the role of cannabis as a "self-medication" agent for them.
Who can participate
Age range18 Years – 55 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
✓. Ages 18 - 55 years
✓. Diagnosis of schizophrenia
✓. Diagnosis of cannabis abuse or dependence
✓. Use of cannabis within the month prior to screening
✓. Willing to remain abstinent for the 14 days before the baseline assessments and throughout the two scans.
✓. Psychiatrically stable
✓. Treated with a stable dose of an antipsychotic medication (except clozapine) for the past month
✓. Not seeking treatment for their cannabis use disorder.
Exclusion criteria
✕. Positive symptoms of psychosis (\> 4 \[moderate\]) on any item of the Positive and Negative Syndrome Scale psychosis subscale (once abstinent) except for the hallucination item. We will exclude for a rating \> 5 for this item.
✕. Cocaine/stimulant use disorder
✕. Pharmacological treatment for addiction
✕. Mental retardation
✕. History of head injury
✕. Metal objects within the body that would contraindicate and MRI
What they're measuring
1
Brain Reward Circuit Activation on fMRI Scan
Timeframe: 3 hours
2
Resting State Connectivity Within the Brain Reward Circuitry
Timeframe: 1 hour after smoking study drug, 3 hours after oral dronabinol