Cannabinoid Receptor Function & Alcoholism - Full Text View

Sponsor:	Yale University
Collaborator:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00624715

Purpose

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	Intervention	Phase
Alcoholism	Drug: THC Drug: Placebo	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science
Official Title:	Cannabinoid Receptor Function & Alcoholism: Effects of Δ-9-THC

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism Smoking

Drug Information available for: Ethanol

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:

Clinician Administered Dissociative Symptoms Scale, Visual Analog Scale ("High" rating), Rey Auditory Verbal Learning Test [ Time Frame: Baseline, +15, +25 (RAVLT only), +70, +240 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	36
Study Start Date:	July 2007
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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).

Arms

Assigned Interventions

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).

Eligibility

Ages Eligible for Study:	18 Years to 30 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Exposure to cannabis at least once

Exclusion Criteria:

Pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00624715

Contacts

Contact: Jacqueline Elander, B.A.

203-932-5711 ext 4523

jacqueline.elander@yale.edu

Locations

United States, Connecticut
VA Connecticut Healthcare System	Recruiting
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

More Information

No publications provided

Responsible Party:	Deepak Cyril D'Souza, M.D., Yale University School of Medicine, Dept of Psychiatry
ClinicalTrials.gov Identifier:	NCT00624715 History of Changes
Other Study ID Numbers:	0707002888, R21 AA 16311
Study First Received:	February 18, 2008
Last Updated:	July 26, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Tetrahydrocannabinol
Hallucinogens
Physiological Effects of Drugs
Pharmacologic Actions

Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on February 12, 2012