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CompletedNCT00678730Updated Mar 9, 2022

Pharmacogenetics of Cannabinoid Response

An Early Phase 1 interventional study of delta 9 tetrahydrocannabinol in COMT Gene Polymorphism, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-09.

Sponsored by Yale University · Early Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was Sep 2014, 12 years ago, and no results have been posted to the registry.
  • Registered 8 months after the study started (first participant enrolled Aug 2007, registered May 2008).
Phase
Early Phase 1
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

This study attempts to examine genetic influences on the effects of tetrahydrocannabinol (Δ9-THC), the active ingredient of marijuana, cannabis, "ganja", or "pot".

02

Conditions studied

  • COMT Gene Polymorphism

Keywords

  • THC
  • COMT gene polymorphism
  • schizophrenia
  • cannabis use
03

In context

Lead sponsor

Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.

Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 18 and 55 years (extremes included) on the day of the first dosing.

Exclusion criteria

Exclusion Criteria:

  • Cannabis naïve individuals.
05

Study design

Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
72 participants (actual)

Study arms

  • Active comparator
    1

    * Very low dose (0.005 mg/kg = 0.35 mg in a 70kg individual) THC, dissolved in ethanol. This dose is roughly equivalent to smoking 1/10th of a marijuana cigarette, or "joint". * Low dose (0.025 mg/kg = 1.75 mg in a 70kg individual) THC, dissolved in ethanol. This dose is roughly equivalent to smoking 1/2 of a marijuana cigarette, or "joint". * Medium dose (0.05 mg/kg = 3.5 mg in a 70 kg individual) THC, dissolved in ethanol. This dose is roughly equivalent to smoking 1 marijuana cigarette, or "joint".

    Drug: delta 9 tetrahydrocannabinol

  • Placebo comparator
    2

    small amount of ethanol, (quarter teaspoon), with no THC

    Drug: delta 9 tetrahydrocannabinol

Interventions

  • Drugdelta 9 tetrahydrocannabinol

    0.05 mg/kg of THC dissolved in ethanol intravenously over 20 minutes

    Also known as: Marijuana, cannabis

06

What researchers measure

Primary outcomes

  1. Behavioral Measures

    Time frame: Baseline, +15, +25, +60, +300

07

Study locations

1 site
  • VA Connecticut Healthcare System
    West Haven, Connecticut 06516, United States
08

References and documents

Publications

  • Ranganathan M, De Aquino JP, Cortes-Briones JA, Radhakrishnan R, Pittman B, Bhakta S, D'Souza DC. Highs and lows of cannabinoid-dopamine interactions: effects of genetic variability and pharmacological modulation of catechol-O-methyl transferase on the acute response to delta-9-tetrahydrocannabinol in humans. Psychopharmacology (Berl). 2019 Nov;236(11):3209-3219. doi: 10.1007/s00213-019-05273-5. Epub 2019 Jun 11. PubMed 31187152 ↗
  • Ranganathan M, Radhakrishnan R, Addy PH, Schnakenberg-Martin AM, Williams AH, Carbuto M, Elander J, Pittman B, Andrew Sewell R, Skosnik PD, D'Souza DC. Tetrahydrocannabinol (THC) impairs encoding but not retrieval of verbal information. Prog Neuropsychopharmacol Biol Psychiatry. 2017 Oct 3;79(Pt B):176-183. doi: 10.1016/j.pnpbp.2017.06.019. Epub 2017 Jun 20. PubMed 28642081 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00678730
Lead sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
Responsible party
Deepak C. D'Souza (Principal Investigator, Yale University) — Principal investigator
First posted
May 15, 2008
Start date
Aug 23, 2007
Primary completion
Sep 11, 2014
Completion
Sep 11, 2014
Last update
Mar 9, 2022

Study contacts

Deepak D'Souza, M.D.
principal investigator · Yale University

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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