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NCT04231643 · ClinicalTrials.gov registry record · Early Phase 1
Effects of Cannabis on Cognition and Endocannabinoid Levels in Bipolar Disorder Patients and Healthy Volunteers
A Early Phase 1 study, sponsored by University of California, San Diego.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 19
- Enrollment target
NCT04231643 is a Early Phase 1 study that was terminated before completion, run by University of California, San Diego. The registered enrollment target is 19 participants.
The verdict
NCT04231643, a Early Phase 1 study, was terminated before completion, sponsored by University of California, San Diego.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Placebos
- DRUG Epidiolex
- DRUG Dronabinol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2021-09-01 |
| Est. Completion | 2023-11-28 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04231643
The ClinicalTrials.gov registry entry for NCT04231643 describes a study currently listed as terminated, categorized as Early Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebos is the first listed.
NCT04231643 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04231643 about?
NCT04231643 is a clinical study titled "Effects of Cannabis on Cognition and Endocannabinoid Levels in Bipolar Disorder Patients and Healthy Volunteers". 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. Ne...
What is the current status of trial NCT04231643?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 19 participants. The study started on 2021-09-01. Estimated completion is 2023-11-28.
What interventions are being tested in trial NCT04231643?
The interventions under investigation include: Placebos (DRUG), Epidiolex (DRUG), Dronabinol (DRUG).
Who is sponsoring clinical trial NCT04231643?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
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