Cannabinoid Receptor Function & Alcoholism
1 other identifier
interventional
29
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2007
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 9, 2007
CompletedFirst Submitted
Initial submission to the registry
February 18, 2008
CompletedFirst Posted
Study publicly available on registry
February 27, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 22, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 22, 2010
CompletedMarch 11, 2022
February 1, 2022
2.9 years
February 18, 2008
February 23, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Clinician Administered Dissociative Symptoms Scale, Visual Analog Scale ("High" rating), Rey Auditory Verbal Learning Test
Baseline, +15, +25 (RAVLT only), +70, +240
Study Arms (2)
THC
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
Placebo
PLACEBO COMPARATORPlacebo: Small amount of ethanol IV (in the vein), (quarter teaspoon).
Interventions
* 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
Eligibility Criteria
You may qualify if:
- Exposure to cannabis at least once
You may not qualify if:
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Connecticut Healthcare System
West Haven, Connecticut, 06516, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Deepak D'Souza, M.D.
Yale University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 18, 2008
First Posted
February 27, 2008
Study Start
August 9, 2007
Primary Completion
June 22, 2010
Study Completion
June 22, 2010
Last Updated
March 11, 2022
Record last verified: 2022-02