Cannabinoid Receptor Function & Alcoholism

Cannabinoid Receptor Function & Alcoholism: Effects of Δ-9-THC

This study attempts to characterize the effects of tetrahydrocannabinol (THC). Tetrahydrocannabinol is the active ingredient of marijuana, cannabis, "ganja", or "pot". This study will involve healthy volunteers who 1) have no history of alcoholism in their family or 2) have a family history of alcoholism. This study looks at individuals with or without a family history of alcoholism to determine if there is a difference between the two groups in the response to THC.

Study Overview

• Status: Completed
• Conditions: Alcoholism
• Intervention / Treatment: Drug: THC; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • West Haven, Connecticut, United States, 06516
      • VA Connecticut Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Exposure to cannabis at least once

Exclusion Criteria:

• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: THC; High dose: 0.036 mg/kg (2.5 mg in a 70 kg individual) IV (in the vein) dissolved in ethanol.Equivalent to smoking a full joint; Low dose: 0.018 mg/kg (1.25 mg in a 70kg individual)IV (in the vein) dissolved in ethanol.Equivalent to smoking ½ of a joint; Very low dose: 0.0036 mg/kg (0.25 mg in a 70 kg individual)IV (in the vein) dissolved in ethanol.Equivalent to smoking 1/10 of a joint	Drug: THC; High dose: 0.036 mg/kg (2.5 mg in a 70 kg individual)IV (in the vein) dissolved in ethanol. Equivalent to smoking a full joint; Low dose: 0.018 mg/kg (1.25 mg in a 70kg individual) IV (in the vein) dissolved in ethanol.Equivalent to smoking ½ of a joint; Very low dose: 0.0036 mg/kg (0.25 mg in a 70 kg individual)IV (in the vein) dissolved in ethanol. Equivalent to smoking 1/10 of a joint
Placebo Comparator: Placebo; Placebo: Small amount of ethanol IV (in the vein), (quarter teaspoon).	Drug: Placebo; Placebo: Small amount of ethanol IV (in the vein), (quarter teaspoon).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinician Administered Dissociative Symptoms Scale, Visual Analog Scale ("High" rating), Rey Auditory Verbal Learning Test	Baseline, +15, +25 (RAVLT only), +70, +240

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Deepak D'Souza, M.D., Yale University

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2007
• Primary Completion (Actual): June 22, 2010
• Study Completion (Actual): June 22, 2010

Study Registration Dates

• First Submitted: February 18, 2008
• First Submitted That Met QC Criteria: February 26, 2008
• First Posted (Estimate): February 27, 2008

Study Record Updates

• Last Update Posted (Actual): March 11, 2022
• Last Update Submitted That Met QC Criteria: February 23, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism
• Other Study ID Numbers: 0707002888

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No