Cannabis Effects as a Function of Sex (CanSex)
Maneno muhimu
Kikemikali
Maelezo
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.
Tarehe
| Imethibitishwa Mwisho: | 04/30/2020 |
| Iliyowasilishwa Kwanza: | 05/06/2020 |
| Uandikishaji uliokadiriwa Uliwasilishwa: | 05/10/2020 |
| Iliyotumwa Kwanza: | 05/11/2020 |
| Sasisho la Mwisho Liliwasilishwa: | 05/10/2020 |
| Sasisho la Mwisho Lilichapishwa: | 05/11/2020 |
| Tarehe halisi ya kuanza kwa masomo: | 08/31/2020 |
| Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 08/31/2024 |
| Tarehe ya Kukamilisha Utafiti: | 08/31/2025 |
Hali au ugonjwa
Uingiliaji / matibabu
Drug: Active Cannabis
Drug: Placebo
Awamu
Vikundi vya Arm
| Mkono | Uingiliaji / matibabu |
|---|---|
| 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) |
Vigezo vya Kustahiki
| Zama zinazostahiki Kujifunza | 21 Years Kwa 21 Years |
| Jinsia Inastahiki Kujifunza | All |
| Hupokea Wajitolea wa Afya | Ndio |
| Vigezo | 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 |
Matokeo
Hatua za Matokeo ya Msingi
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]
Hatua za Matokeo ya Sekondari
1. Drug reinforcement [5 hours]
