Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans (THC-Gender)
|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: NCT02781519|
Recruitment Status : Recruiting
First Posted : May 24, 2016
Last Update Posted : June 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cannabis||Drug: THC Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 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|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
Active Comparator: THC
Active THC (0.015mg/kg) administered intravenously over 10 minutes.
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.
Control: small amount of alcohol (quarter teaspoon), with no THC over 10 minutes
- 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"
- 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
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
|Contact: Christina Luddy, BS||203-932-5711 ext firstname.lastname@example.org|
|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 email@example.com|