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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: Clinical Trial Early Phase 1 study, sponsored by University of California, San Diego.
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, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
This is an experimental measure and not a scale with specific anchor points. Lower scores reflect increased risk-taking
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 |
Why NCT04231643 stopped before completion
NCT04231643 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebos is the first listed.
NCT04231643 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04231643's enrollment target sits among peer trials
19 1292nd of 2000 higher than 685 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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