Cannabis Effects as a Function of Sex (CanSex)
关键词
抽象
描述
The proposed study will compare smoked cannabis's dose-dependent, analgesic and abuse-related effects between men and women and variables that underlie these sex-dependent differences, including pharmacokinetics of THC.
日期
| 最后验证: | 04/30/2020 |
| 首次提交: | 05/06/2020 |
| 提交的预估入学人数: | 05/10/2020 |
| 首次发布: | 05/11/2020 |
| 上次提交的更新: | 05/10/2020 |
| 最近更新发布: | 05/11/2020 |
| 实际学习开始日期: | 08/31/2020 |
| 预计主要完成日期: | 08/31/2024 |
| 预计完成日期: | 08/31/2025 |
状况或疾病
干预/治疗
Drug: Active Cannabis
Drug: Placebo
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Placebo Comparator: Placebo Smoked Cannabis (~0% THC) | Drug: Placebo Placebo smoked cannabis (no THC) |
| Experimental: Low strength cannabis Smoked Cannabis (~4% THC) | |
| Experimental: Higher strength cannabis Smoked Cannabis (~10% THC) |
资格标准
| 有资格学习的年龄 | 21 Years 至 21 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Male or non-pregnant female aged 21-55 years - Report use of cannabis an average of 1-7 days per week - Not currently seeking treatment for their cannabis use - Urine test positive for recent cannabis use for heavy users - No reported adverse effects with cannabis smoking in light users - Have a Body Mass Index from 18.5 - 34kg/m2. - Able to perform all study procedures - FEMALES: Currently practicing a non-hormonal effective form of birth control - FEMALES: Must be regularly cycling Exclusion Criteria: - Meeting DSM-V criteria for any substance use disorder other than nicotine, caffeine, or cannabis use disorder - Report using other illicit drugs in the prior 4 weeks - History or current evidence of severe psychiatric illness or medical condition judged by the study physician and PI to put the participant at greater risk of experiencing adverse events due to completion of study procedures, interfere with their ability to participate in the study, or their capacity to provide informed consent. - Current use of medical cannabis, prescription analgesics, or any medications that may affect study outcomes - Current pain - Insensitivity to the cold water stimulus of the Cold Pressor Test - FEMALES: using a hormonal contraceptive |
结果
主要结果指标
1. Subject-rated drug effects [5 hours]
2. Analgesia as measured using the Cold Pressor Test [5 hours]
3. Pharmacokinetics of THC and metabolites [5 hours]
次要成果指标
1. Drug reinforcement [5 hours]
