Verified August 2016 by Yale University
Sponsor:
Information provided by (Responsible Party):
Mohini Ranganathan, Yale University
ClinicalTrials.gov Identifier:
NCT02781519
First received: May 16, 2016
Last updated: August 17, 2016
Last verified: August 2016
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.
| Cannabis | Drug: THC Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans |
| Estimated Enrollment: | 100 |
| Study Start Date: | June 2015 |
| Estimated Study Completion Date: | June 2020 |
| Estimated Primary Completion Date: | June 2020 (Final data collection date for primary outcome measure) |
| 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 |
| Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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)
Please refer to this study by its ClinicalTrials.gov identifier: NCT02781519
| Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine | |
| West Haven, Connecticut, United States, 06516 | |
Yale University
| Responsible Party: | Mohini Ranganathan, Assistant Professor of Psychiatry, Yale University |
| ClinicalTrials.gov Identifier: | NCT02781519 History of Changes |
| Other Study ID Numbers: | 1505015940 |
| Study First Received: | May 16, 2016 |
| Last Updated: | August 17, 2016 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
| Cannabinoid Receptor Agonists Cannabinoid Receptor Modulators Dronabinol Hallucinogens Physiological Effects of Drugs Psychotropic Drugs Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on September 13, 2016