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Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans (THC-Gender)

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ClinicalTrials.gov Identifier: NCT02781519
Recruitment Status : Recruiting
First Posted : May 24, 2016
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Mohini Ranganathan, Yale University

Brief Summary:
The purpose of the study is to characterize the acute effects of cannabinoids in women relative to men and to begin probing the mechanisms that may underlie gender differences.

Condition or disease Intervention/treatment Phase
Cannabis Drug: THC Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans
Study Start Date : June 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Dronabinol
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: THC
Active THC (0.015mg/kg) administered intravenously over 10 minutes.
Drug: THC
Active THC (0.015mg/kg) administered over 10 minutes
Other Name: Delta-9-Tetrahydrocannabinol
Placebo Comparator: Placebo
Control: small amount of alcohol intravenously (quarter teaspoon), with no THC over 10 minutes.
Drug: Placebo
Control: small amount of alcohol (quarter teaspoon), with no THC over 10 minutes



Primary Outcome Measures :
  1. Rewarding Effects measured by Visual Analog Scale (VAS) [ Time Frame: changes in "high" assessed over the following timepoints: baseline, +10, +80, and +200 minutes after THC infusion begins ]
    subjective measure of THC induced "high"

  2. Verbal Learning: measured by Rey Auditory Verbal Learning Test (AVLT) [ Time Frame: 25 minutes after THC infusion begins ]
    measured as delay recall on the AVLT



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • at least one lifetime exposure to cannabis
  • good physical and mental health

Exclusion Criteria:

  • cannabis naive individuals
  • major current or recent stressors
  • taking estrogen supplements or oral contraceptive pills (for women)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02781519


Contacts
Contact: Christina Luddy, BS 203-932-5711 ext 4549 christina.luddy@yale.edu

Locations
United States, Connecticut
Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine Recruiting
West Haven, Connecticut, United States, 06516
Contact: Christina Luddy, BS    203-932-5711 ext 4549    christina.luddy@yale.edu   
Sponsors and Collaborators
Yale University

Responsible Party: Mohini Ranganathan, Assistant Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT02781519     History of Changes
Other Study ID Numbers: 1505015940
First Posted: May 24, 2016    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Dronabinol
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists