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Cannabinoid Receptor Function & Alcoholism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00624715
Recruitment Status : Active, not recruiting
First Posted : February 27, 2008
Last Update Posted : November 30, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

February 18, 2008
February 27, 2008
November 30, 2017
July 2007
October 2018   (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 ]
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). ]
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: Quadruple (Participant, Care Provider, 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.
 
Active, not recruiting
36
December 2018
October 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Exposure to cannabis at least once

Exclusion Criteria:

  • Pregnancy
Sexes Eligible for Study: All
18 Years to 30 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00624715
0707002888
Not Provided
Not Provided
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
November 2017

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