Pharmacogenetics of Cannabinoid Response

Pharmacogenetics of Cannabinoid Response

Sponsors

Lead Sponsor: Yale University

Collaborator: National Institute on Drug Abuse (NIDA)

Source Yale University
Brief Summary

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

Overall Status Active, not recruiting
Start Date 2007-07-01
Completion Date 2021-12-01
Primary Completion Date 2021-06-01
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Behavioral Measures Baseline, +15, +25, +60, +300
Enrollment 162
Condition
Intervention

Intervention Type: Drug

Intervention Name: delta 9 tetrahydrocannabinol

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

Eligibility

Criteria:

Inclusion Criteria: - 18 and 55 years (extremes included) on the day of the first dosing. Exclusion Criteria: - Cannabis naïve individuals.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

55 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Deepak D'Souza, M.D. Principal Investigator Yale University
Location
Facility: VA Connecticut Healthcare System
Location Countries

United States

Verification Date

2021-01-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Yale University

Investigator Full Name: Deepak C. D'Souza

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Label: 1

Type: Active Comparator

Description: 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".

Label: 2

Type: Placebo Comparator

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

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Basic Science

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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