Overview

This trial is active, not recruiting.

Condition alcoholism
Treatments thc, placebo
Phase phase 1
Sponsor Yale University
Collaborator National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Start date July 2007
End date October 2017
Trial size 36 participants
Trial identifier NCT00624715, 0707002888

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose basic science
Arm
(Active Comparator)
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
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: Small amount of ethanol IV (in the vein), (quarter teaspoon).
placebo
Placebo: Small amount of ethanol IV (in the vein), (quarter teaspoon).

Primary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 30 years old.

Inclusion Criteria: - Exposure to cannabis at least once Exclusion Criteria: - Pregnancy

Additional Information

Official title Cannabinoid Receptor Function & Alcoholism: Effects of Δ-9-THC
Principal investigator Deepak D'Souza, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Yale University.