Cannabis Effects as a Function of Sex (CanSex) (CanSex)

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

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

Study Overview

• Status: Recruiting
• Conditions: Pain; Abuse, Drug
• Intervention / Treatment: Drug: Placebo Cannabis; Drug: Active Cannabis

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Vincent Acebo; Phone Number: 310-983-3417; Email: vacebo@mednet.ucla.edu
• Study Contact Backup: Name: Ziva Cooper, Phd; Phone Number: 310-206-9942; Email: zcooper@mednet.ucla.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • University of California, Los Angeles
      • Contact: Vincent Acebo; Phone Number: 310-983-3417; Email: vacebo@mednet.ucla.edu
      • Principal Investigator: Ziva Cooper, PhD
      • Contact: Ziva Cooper, Phd; Phone Number: 310-206-9942; Email: zcooper@mednet.ucla.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Smoked Cannabis (~0% THC)	Drug: Placebo Cannabis; Placebo smoked cannabis (no THC)
Experimental: Low strength cannabis; Smoked Cannabis (~4% THC)	Drug: Active Cannabis; Smoked cannabis with THC
Experimental: Higher strength cannabis; Smoked Cannabis (~10% THC)	Drug: Active Cannabis; Smoked cannabis with THC

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Ziva Cooper, PhD, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2021
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: May 7, 2020
• First Submitted That Met QC Criteria: May 11, 2020
• First Posted (Actual): May 12, 2020

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Pain; Cannabis; THC
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Marijuana Abuse
• Other Study ID Numbers: 19-000876; R01DA047296 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No