Cannabinoid Receptor Function & Alcoholism

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00624715
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
• Enrollment: 29
• Location: 1
• Arms: 2
• Actual Duration (Months): 34.4
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Alcoholism	Drug: THC; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 29 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Cannabinoid Receptor Function & Alcoholism: Effects of Δ-9-THC
• Actual Study Start Date: Aug 9, 2007
• Actual Primary Completion Date: Jun 22, 2010
• Actual Study Completion Date: Jun 22, 2010

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

1. Clinician Administered Dissociative Symptoms Scale, Visual Analog Scale ("High" rating), Rey Auditory Verbal Learning Test [Baseline, +15, +25 (RAVLT only), +70, +240]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 30 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Exposure to cannabis at least once

Exclusion Criteria:

• Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Connecticut Healthcare System	West Haven	Connecticut	United States	06516

Sponsors and Collaborators

• Yale University
• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

• Principal Investigator: Deepak D'Souza, M.D., Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Deepak C. D'Souza, Professor, Yale University
• ClinicalTrials.gov Identifier: NCT00624715
• Other Study ID Numbers: 0707002888
• First Posted: Feb 27, 2008
• Last Update Posted: Mar 11, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Alcoholism

Study Results

No Results Posted as of Mar 11, 2022