NCT03206463 (THC-BD) is a Phase 1 clinical trial of 4 mg Delta-9-THC in Delta-9-Tetrahydroncannabinol, sponsored by Yale University.

Who is sponsoring NCT03206463?

NCT03206463 is sponsored by Yale University.

What drugs are being tested in NCT03206463?

Interventions in NCT03206463: 4 mg Delta-9-THC, Placebo, 2 mg Delta-9-THC.

What condition does NCT03206463 study?

NCT03206463 studies Delta-9-Tetrahydroncannabinol, Bipolar Disorder, Healthy Controls.

Is NCT03206463 still recruiting?

NCT03206463 is currently terminated. Last updated 31 January 2022.

Last reviewed 2022-01-31 · How we verify

NCT03206463: THC-BD

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Cognitive and Psychophysiological Effects of Delta-9-Tetrahydrocannabinol in Bipolar Disorder

Terminated Phase 1 Last updated 31 January 2022

What this trial tests

Phase 1 trial testing 4 mg Delta-9-THC in Delta-9-Tetrahydroncannabinol in 2 participants. Terminated before completion.

Timeline

1 August 2017

Primary endpoint
29 September 2017

29 September 2017

Quick facts

Lead sponsor	Yale University
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	basic science
Enrollment	2
Start date	1 August 2017
Primary completion	29 September 2017
Estimated completion	29 September 2017
Sites	1 location across United States

Drugs / interventions tested

4 mg Delta-9-THC — full drug profile →
Placebo
2 mg Delta-9-THC — full drug profile →

Conditions studied

Delta-9-Tetrahydroncannabinol — all drugs for Delta-9-Tetrahydroncannabinol →
Bipolar Disorder — all drugs for Bipolar Disorder →
Healthy Controls — all drugs for Healthy Controls →

Sponsor

Yale University

Who can join

Adults 18 to 55, any sex, with Delta-9-Tetrahydroncannabinol or Bipolar Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The overarching goal of this study is to characterize the acute cognitive and psychophysiological effects of the main psychoactive constituent of cannabis, 9-delta-tetrahydrocannabinol (THC) in individuals with euthymic bipolar disorder (BD), and to begin probing the mechanisms that may underlie its effects in this illness. This study is expected to contribute to a better characterization of specific effects of THC in individuals with BD compared to healthy controls (HC).

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
The Use of Psychedelics in the Treatment of Medical Conditions: An Analysis of Currently Registered Psychedelics Studies in the American Drug Trial Registry.
Kurtz JS, Patel NA, Gendreau JL, Yang C, et al · · 2022 · cited 19× · PMID 36259015 · DOI 10.7759/cureus.29167

Verify or expand the search:

Other Yale University trials

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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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03206463 (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 Yale University
Last refreshed: 31 January 2022

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/NCT03206463.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing