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

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ClinicalTrials.gov Identifier: NCT02811510
Recruitment Status : Recruiting
First Posted : June 23, 2016
Last Update Posted : June 26, 2018
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: Placebo Drug: Dronabinol Phase 1

Detailed Description:
To characterize the acute effects of oral Dronabinol (10 mg capsule) in women relative to men and to begin probing the mechanisms that may underlie gender differences.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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: Sub-Study I
Study Start Date : June 2016
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

Arm Intervention/treatment
Active Comparator: THC
10 mg Dronabinol will be administered orally.
Drug: Dronabinol
10 mg capsule of Dronabinol will be administered orally.
Other Name: Delta-9-Tetrahydrocannabinol

Placebo Comparator: Placebo
Placebo pill (no active cannabinoids).
Drug: Placebo
Placebo pill (no active cannabinoids)




Primary Outcome Measures :
  1. Change from Baseline: Rewarding Effects measured by Visual Analog Scale (VAS) [ Time Frame: changes in "high" assessed over the following timepoints: baseline, +60, +80, +120, +180, +300 minutes after start of oral Dronabinol administration. ]
    Subjective measure of THC induced "high"

  2. Change from Baseline: Verbal Learning: Measured by Rey Auditory Verbal Learning Test (RAVLT) [ Time Frame: baseline and +80 minutes after start of oral Dronabinol administration. ]
    Measured as delay recall on the AVLT



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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)
  • Sesame oil allergy

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): NCT02811510


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

Locations
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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   
Principal Investigator: Mohini Ranganathan, MD         
Sponsors and Collaborators
Yale University

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Responsible Party: Mohini Ranganathan, Assistant Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT02811510     History of Changes
Other Study ID Numbers: 1505015940.A
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
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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