Cannabis Effects as a Function of Sex (CanSex)

Study Overview
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Brief Summary
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The purpose of this research is to assess the impact of cannabis on the analgesic and abuse-related effects between men and women

Detailed Description
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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.

Official Title
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Sex-dependent Effects of Cannabis: Assessing Analgesic, Abuse-related and Pharmacokinetic Differences Between Men and Women

Conditions
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Pain, Abuse, Drug

Intervention / Treatment
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* Drug: Active Cannabis
* Drug: Placebo Cannabis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Smoked Cannabis ( 0% THC) | Drug: Placebo Cannabis<br>* Placebo smoked cannabis (no THC)<br>|
| Experimental: Low strength cannabis<br>Smoked Cannabis ( 4% THC) | Drug: Active Cannabis<br>* Smoked cannabis with THC<br>|
| Experimental: Higher strength cannabis<br>Smoked Cannabis ( 10% THC) | Drug: Active Cannabis<br>* Smoked cannabis with THC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject-rated drug effects | Average and peak subjective ratings of drug effects associated with abuse liability as measured using visual analogue scales (VAS; 1-100mm). | 5 hours | 
| Analgesia as measured using the Cold Pressor Test | Peak and average pain threshold and tolerance assessed using the Cold Pressor Test | 5 hours | 
| Pharmacokinetics of THC and metabolites | Plasma levels of THC, 11-OH-THC, and THCCOOH | 5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug reinforcement using the cannabis self-administration task | Average number of cannabis puffs self-administered as a function of cannabis strength and sex. For this task, up to three 'puffs' of cannabis may be chosen for self-administration during each session. | 5 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Cannabis, THC