Pharmacogenetics of Cannabinoid Response
1 other identifier
interventional
72
1 country
1
Brief Summary
This study attempts to examine genetic influences on the effects of tetrahydrocannabinol (Δ9-THC), the active ingredient of marijuana, cannabis, "ganja", or "pot".
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Aug 2007
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 23, 2007
CompletedFirst Submitted
Initial submission to the registry
May 13, 2008
CompletedFirst Posted
Study publicly available on registry
May 15, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 11, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 11, 2014
CompletedMarch 9, 2022
February 1, 2022
7.1 years
May 13, 2008
February 23, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Behavioral Measures
Baseline, +15, +25, +60, +300
Study Arms (2)
1
ACTIVE COMPARATOR* Very low dose (0.005 mg/kg = 0.35 mg in a 70kg individual) THC, dissolved in ethanol. This dose is roughly equivalent to smoking 1/10th of a marijuana cigarette, or "joint". * Low dose (0.025 mg/kg = 1.75 mg in a 70kg individual) THC, dissolved in ethanol. This dose is roughly equivalent to smoking 1/2 of a marijuana cigarette, or "joint". * Medium dose (0.05 mg/kg = 3.5 mg in a 70 kg individual) THC, dissolved in ethanol. This dose is roughly equivalent to smoking 1 marijuana cigarette, or "joint".
2
PLACEBO COMPARATORsmall amount of ethanol, (quarter teaspoon), with no THC
Interventions
0.05 mg/kg of THC dissolved in ethanol intravenously over 20 minutes
Eligibility Criteria
You may qualify if:
- and 55 years (extremes included) on the day of the first dosing.
You may not qualify if:
- Cannabis naïve individuals.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
VA Connecticut Healthcare System
West Haven, Connecticut, 06516, United States
Related Publications (2)
Ranganathan M, De Aquino JP, Cortes-Briones JA, Radhakrishnan R, Pittman B, Bhakta S, D'Souza DC. Highs and lows of cannabinoid-dopamine interactions: effects of genetic variability and pharmacological modulation of catechol-O-methyl transferase on the acute response to delta-9-tetrahydrocannabinol in humans. Psychopharmacology (Berl). 2019 Nov;236(11):3209-3219. doi: 10.1007/s00213-019-05273-5. Epub 2019 Jun 11.
PMID: 31187152DERIVEDRanganathan M, Radhakrishnan R, Addy PH, Schnakenberg-Martin AM, Williams AH, Carbuto M, Elander J, Pittman B, Andrew Sewell R, Skosnik PD, D'Souza DC. Tetrahydrocannabinol (THC) impairs encoding but not retrieval of verbal information. Prog Neuropsychopharmacol Biol Psychiatry. 2017 Oct 3;79(Pt B):176-183. doi: 10.1016/j.pnpbp.2017.06.019. Epub 2017 Jun 20.
PMID: 28642081DERIVED
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
- early 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
- Principal Investigator
Study Record Dates
First Submitted
May 13, 2008
First Posted
May 15, 2008
Study Start
August 23, 2007
Primary Completion
September 11, 2014
Study Completion
September 11, 2014
Last Updated
March 9, 2022
Record last verified: 2022-02