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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04704271
Other study ID # 1505015940.B
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date October 9, 2019
Est. completion date December 1, 2024

Study information

Verified date May 2024
Source Yale University
Contact Christina Luddy, BS
Phone 2039325711
Email christina.luddy@yale.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

To characterize the acute effects of vaporized THC in women relative to men and to begin probing the mechanisms that may underlie gender differences.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 1, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - At least one lifetime exposure to cannabis - Good physical and mental health Exclusion Criteria: - Cannabis naïve individuals - Major current or recent stressors

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Inhaled THC
4 mg inhaled THC
Placebo
Inhaled placebo (no active cannabinoids)

Locations

Country Name City State
United States Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine West Haven Connecticut

Sponsors (1)

Lead Sponsor Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline: Rewarding Effects measured by Visual Analog Scale (VAS) Subjective measure of THC induced "high" Changes in "high" assessed over the following timepoints: baseline, +60, +80, +120, +180, +300 minutes after start of oral Dronabinol administration.
Primary Change from Baseline: Verbal Learning: Measured by Rey Auditory Verbal Learning Test (RAVLT) Measured as delay recall on the AVLT Baseline and +80 minutes after start of oral Dronabinol administration.
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