Pharmacogenetics of Cannabinoid Response

NCT ID: NCT00678730

Last Updated: 2022-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-23

Study Completion Date

2014-09-11

Brief Summary

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

Detailed Description

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Conditions

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COMT Gene Polymorphism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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".

Group Type ACTIVE_COMPARATOR

delta 9 tetrahydrocannabinol

Intervention Type DRUG

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

2

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

Group Type PLACEBO_COMPARATOR

delta 9 tetrahydrocannabinol

Intervention Type DRUG

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

Interventions

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delta 9 tetrahydrocannabinol

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

Intervention Type DRUG

Other Intervention Names

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Marijuana cannabis

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Cannabis naïve individuals.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Deepak C. D'Souza

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Deepak D'Souza, M.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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VA Connecticut Healthcare System

West Haven, Connecticut, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 31187152 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28642081 (View on PubMed)

Other Identifiers

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0706002754

Identifier Type: -

Identifier Source: org_study_id

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