Cannabinoid Receptor Function & Alcoholism

Alcoholism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00624715
• Other study ID #: 0707002888
• Status: Completed
• Phase: Phase 1
• Start date: August 9, 2007
• Est. completion date: June 22, 2010

Study information

• Verified date: February 2022
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 22, 2010
• Est. primary completion date: June 22, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Exposure to cannabis at least once

Exclusion Criteria:

• Pregnancy

Related Conditions & MeSH terms

• Alcoholism

Intervention

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
Placebo: Small amount of ethanol IV (in the vein), (quarter teaspoon).

Locations

Country	Name	City	State
United States	VA Connecticut Healthcare System	West Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician Administered Dissociative Symptoms Scale, Visual Analog Scale ("High" rating), Rey Auditory Verbal Learning Test		Baseline, +15, +25 (RAVLT only), +70, +240