| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01964404 | Cannabis, Schizophrenia and Reward: Self-Medication and Agonist Treatment? | PHASE1 | COMPLETED | 263 | — | — | Jul 1, 2014 | Sep 18, 2021 | Dec 9, 2025 | 2 | United States |
Activation of the Brain Reward Circuit (particularly the nucleus accumbens) in anticipation of monetary reward. The 'Measure' is a mean of the Fisher-Z transform of the inter-regional correlation measured for each participant between the nucleus accumbens and anterior cingulate cortex. The Fisher-transformation creates a normally distributed correlation value for statistical analyses assessing between group differences. A Fisher-Z transform of '0' represents a value of '0' for the estimated correlation, which represents no correlation in the activity time series between the regions. The values reflect strengths of functional connectivity between brain regions that can be compared between groups (e.g. Healthy controls and SCZ-CUD groups who received different study drugs). Means and standard deviations similar to healthy controls would be considered a good outcome.
Resting state connectivity within brain reward circuitry as measured with the Fisher-transformed r value of the connectivity maps between the nucleus accumbans and other brain areas. The Fisher-transformation creates a normally distributed correlation value for statistical analyses assessing between group differences (smoked THC vs placebo; oral dronabinol vs placebo)
| Arm | Type | Description |
|---|---|---|
| Marijuana cigarette and placebo capsule | EXPERIMENTAL | 3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI. |
| Dronabinol and placebo cigarette | EXPERIMENTAL | Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI. |
| Placebo cigarette and placebo capsule | PLACEBO_COMPARATOR | Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI. |
| Name | Type | Description |
|---|---|---|
| Marijuana | DRUG | Smoked plant with THC |
| Dronabinol | DRUG | Capsule with THC |
| Placebo | DRUG | Capsule with no active ingredient |
Inclusion Criteria: Groups 1-3 Participants with schizophrenia and a cannabis use disorder 1. Ages 18 - 55 years 2. Diagnosis of schizophrenia 3. Diagnosis of cannabis abuse or dependence 4. Use of cannabis within the month prior to screening 5. Willing to remain abstinent for the 14 days before t...