Cannabinoid Receptor Function & Alcoholism

This study is currently recruiting participants.

Verified March 2013 by Yale University

Sponsor:

Collaborator:

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Information provided by (Responsible Party):

Deepak C. D'Souza, Yale University

ClinicalTrials.gov Identifier:

NCT00624715

First received: February 18, 2008

Last updated: March 25, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

February 18, 2008

Last Updated Date

March 25, 2013

Start Date ^ICMJE

July 2007

Estimated Primary Completion Date

October 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00624715 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

THC serum levels, visual analog scale (other feeling states - "calm/relaxed", and "tired"), Biphasic Alcohol Effects Scale (BAES), similarities to alcohol effects, comparison to # standard alcohol drinks, long-term follow-up of cannabis use [ Time Frame: Baseline (for VAS, BAES, THC levels), +15 (for VAS, BAES), +20 (THC levels), +70 (for VAS, BAES, THC levels), +240(for VAS, BAES, THC levels, similarity to alcohol effects). Long term followup (1,3, 6 months post study completion). ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Cannabinoid Receptor Function & Alcoholism

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science

Condition ^ICMJE

Alcoholism

Intervention ^ICMJE

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

Study Arm (s)

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

Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2014

Estimated Primary Completion Date

October 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Exposure to cannabis at least once

Exclusion Criteria:

Pregnancy

Gender

Both

Ages

18 Years to 30 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Lawrence Rispoli, B.A.

203-932-5711 ext 4523

lawrence.rispoli@yale.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00624715

Other Study ID Numbers ^ICMJE

0707002888, R21 AA 16311

Has Data Monitoring Committee

Not Provided

Responsible Party

Deepak C. D'Souza, Yale University

Study Sponsor ^ICMJE

Yale University

Collaborators ^ICMJE

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators ^ICMJE

Principal Investigator:

Deepak D'Souza, M.D.

Yale University

Information Provided By

Yale University

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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