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

Primary Purpose

Pain, Abuse, Drug

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Active Cannabis
Placebo Cannabis
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pain focused on measuring Pain, Cannabis, THC

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of California, Los AngelesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Low strength cannabis

Higher strength cannabis

Arm Description

Smoked Cannabis (~0% THC)

Smoked Cannabis (~4% THC)

Smoked Cannabis (~10% THC)

Outcomes

Primary Outcome Measures

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).
Analgesia as measured using the Cold Pressor Test
Peak and average pain threshold and tolerance assessed using the Cold Pressor Test
Pharmacokinetics of THC and metabolites
Plasma levels of THC, 11-OH-THC, and THCCOOH

Secondary Outcome Measures

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.

Full Information

First Posted
May 7, 2020
Last Updated
July 18, 2023
Sponsor
University of California, Los Angeles
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT04385082
Brief Title
Cannabis Effects as a Function of Sex (CanSex)
Acronym
CanSex
Official Title
Sex-dependent Effects of Cannabis: Assessing Analgesic, Abuse-related and Pharmacokinetic Differences Between Men and Women
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 8, 2021 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Abuse, Drug
Keywords
Pain, Cannabis, THC

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Model Description
This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Smoked Cannabis (~0% THC)
Arm Title
Low strength cannabis
Arm Type
Experimental
Arm Description
Smoked Cannabis (~4% THC)
Arm Title
Higher strength cannabis
Arm Type
Experimental
Arm Description
Smoked Cannabis (~10% THC)
Intervention Type
Drug
Intervention Name(s)
Active Cannabis
Intervention Description
Smoked cannabis with THC
Intervention Type
Drug
Intervention Name(s)
Placebo Cannabis
Intervention Description
Placebo smoked cannabis (no THC)
Primary Outcome Measure Information:
Title
Subject-rated drug effects
Description
Average and peak subjective ratings of drug effects associated with abuse liability as measured using visual analogue scales (VAS; 1-100mm).
Time Frame
5 hours
Title
Analgesia as measured using the Cold Pressor Test
Description
Peak and average pain threshold and tolerance assessed using the Cold Pressor Test
Time Frame
5 hours
Title
Pharmacokinetics of THC and metabolites
Description
Plasma levels of THC, 11-OH-THC, and THCCOOH
Time Frame
5 hours
Secondary Outcome Measure Information:
Title
Drug reinforcement using the cannabis self-administration task
Description
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.
Time Frame
5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ziva Cooper, PhD
Phone
310-206-9942
Email
zcooper@mednet.ucla.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Vincent Acebo
Phone
310-983-3417
Email
vacebo@mednet.ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ziva Cooper, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ziva Cooper, Phd
Phone
310-206-9942
Email
zcooper@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Vincent Acebo
Phone
310-983-3417
Email
vacebo@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Ziva Cooper, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Cannabis Effects as a Function of Sex (CanSex)

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