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NCT04231643
Effects of Cannabis on Cognition and Endocannabinoid Levels in Bipolar Disorder Patients and Healthy Volunteers
EARLY_PHASE1 trial testing Dronabinol in Bipolar Disorder in 19 participants. Terminated before completion.
28 November 2023
Quick facts
| Lead sponsor | University of California, San Diego |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | basic science |
| Enrollment | 19 |
| Start date | 1 September 2021 |
| Primary completion | 28 November 2023 |
| Estimated completion | 28 November 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Dronabinol (DRONABINOL) — full drug profile →
- Epidiolex (CANNABIDIOL) — full drug profile →
- Placebos — full drug profile →
Conditions studied
- Bipolar Disorder — all drugs for Bipolar Disorder →
Sponsor
University of California, San Diego
Who can join
Adults 18 to 50, any sex, with Bipolar Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Cannabinoids and their therapeutic applications in mental disorders
.
Scherma M, Muntoni AL, Riedel G, Fratta W, et al · · 2020 · cited 22× · PMID 33162770 · DOI 10.31887/dcns.2020.22.3/pfadda -
Cannabidiol for Mood Disorders: A Call for More Research.
Bartoli F, Bachi B, Calabrese A, Moretti F, et al · · 2021 · cited 2× · PMID 32406255 · DOI 10.1177/0706743720926798
Verify or expand the search:
- PubMed search for NCT04231643
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04231643 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of California, San Diego
- Last refreshed: 10 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04231643.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing