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Cannabinoid Receptor Function & Alcoholism

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Yale University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Deepak C. D'Souza, Yale University
ClinicalTrials.gov Identifier:
NCT00624715
First received: February 18, 2008
Last updated: September 24, 2014
Last verified: September 2014

February 18, 2008
September 24, 2014
July 2007
October 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00624715 on ClinicalTrials.gov Archive Site
Not Provided
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 ]
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Alcoholism
  • 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).
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
36
December 2014
October 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Exposure to cannabis at least once

Exclusion Criteria:

  • Pregnancy
Both
18 Years to 30 Years
Yes
Contact: Christina Luddy 203-932-5711 ext 4549 christina.luddy@yale.edu
United States
 
NCT00624715
0707002888, R21 AA 16311
Not Provided
Deepak C. D'Souza, Yale University
Yale University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Deepak D'Souza, M.D. Yale University
Yale University
September 2014

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