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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA043535 | U.S. NIH Grant/Contract | View source |
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Budgetary limitations prevented us from completing our planned sample size.
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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Cannabis use is associated with younger age at onset of bipolar disorder, poor outcome, and more frequent manic episodes, but the effects of cannabis on cognition are less clear. Contrary to reports among non-psychiatric patients, cannabis may improve cognition among people with bipolar disorder. Nevertheless, no study to date has systematically tested the acute effects of cannabis on cognition in bipolar disorder. Therefore, the investigators propose to determine the effects of oral cannabinoid administration on cognitive domains relevant to bipolar disorder, e.g., arousal, decision making, cognitive control, inhibition, and temporal perception (sense of timing). In addition, the investigators will evaluate different doses of the two major components of cannabis, cannabidiol and ∆9-tetrahydrocannabinol, and compare them to placebo on these neurocognitive measures. The investigators will also test the effects of acute exposure to cannabinoids on cerebrospinal levels of anandamide and homovanillic acid - markers of endocannabinoid and dopamine activity in the brain, respectively. These studies will provide information that effectively bridges the fields of addiction and general psychiatry, informing treatment development for co-morbid substance abuse and psychiatric disorders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bipolar Disorder | Experimental | adults with bipolar disorder |
|
| Healthy Volunteers | Active Comparator | adults with no psychiatric disease |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dronabinol | Drug | one-time oral administration of 5 mg dronabinol |
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| Measure | Description | Time Frame |
|---|---|---|
| Score on Iowa Gambling Task | This is an experimental measure and not a scale with specific anchor points. Lower scores reflect increased risk-taking | one day |
| Score on Progressive Ratio Test | This is an experimental measure and not a scale with specific anchor points. Higher scores indicate increased willingness to work for a reward | one day |
| Scores on Probabilistic Learning Task | This is an experimental measure and not a scale with specific anchor points. Measures decision-making strategies such as win-stay, lose-shift. | one day |
| Scores on Continuous Performance Task | This is an experimental measure and not a scale with specific anchor points. Higher scores reflect better attention and ability to discriminate important information from unimportant information | one day |
| Percent Prepulse Inhibition (PPI) | This is a physiological measure and not a scale with specific anchor points. Higher percent PPI reflects better sensorimotor gating | one day |
| motor activity in the human Behavioral Pattern Monitor | This is an experimental measure and not a scale with specific anchor points. Subjects' behavior in an open field (a room filled with novel objects) is quantified over a 15-minute period via amount of motor activity as measured by a wearable accelerometer. Increased motor activity reflects increased tendency to engage in exploratory behavior. | one day |
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Inclusion Criteria:
Exclusion Criteria:
Participants will be asked about which gender they identify with
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| Name | Affiliation | Role |
|---|---|---|
| William Perry, PhD | UCSD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego Medical Center | San Diego | California | 92103 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 27, 2023 | Feb 16, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013759 | Dronabinol |
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Epidiolex | Drug | one-time oral administration of 600 mg Epidiolex |
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| Placebos | Drug | one-time oral administration of placebo |
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| object interactions in the human Behavioral Pattern Monitor | This is an experimental measure and not a scale with specific anchor points. Subjects' behavior in an open field (a room filled with novel objects) is quantified over a 15-minute period via video ratings that quantify number of interactions with novel objects. Increased object interactions reflects increased novelty-seeking behavior. | one day |
| cerebrospinal fluid levels of anandamide | Reflects increased availability of the endogenous cannabinoid anandamide in the brain | one day |