Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans: Sub-Study I (THC-Gender-I)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02811510|
Recruitment Status : Recruiting
First Posted : June 23, 2016
Last Update Posted : July 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cannabis||Drug: Placebo Drug: Dronabinol||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|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|
Active Comparator: THC
10 mg Dronabinol will be administered orally.
10 mg capsule of Dronabinol will be administered orally.
Other Name: Delta-9-Tetrahydrocannabinol
Placebo Comparator: Placebo
Placebo pill (no active cannabinoids).
Placebo pill (no active cannabinoids)
- 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"
- 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
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
|Contact: Leigh Taylor Flynn, BS||203-932-5711 ext firstname.lastname@example.org|
|Contact: Christina Luddy, BS||203-932-5711 ext email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator: Mohini Ranganathan, MD|