Cannabis Effects as a Function of Sex

NCT ID: NCT04385082

Last Updated: 2025-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-08

Study Completion Date

2026-06-30

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.

Conditions

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Pain Abuse, Drug

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Smoked Cannabis (\~0% THC)

Group Type PLACEBO_COMPARATOR

Placebo Cannabis

Intervention Type DRUG

Placebo smoked cannabis (no THC)

Low strength cannabis

Smoked Cannabis (\~4% THC)

Group Type EXPERIMENTAL

Active Cannabis

Intervention Type DRUG

Smoked cannabis with THC

Higher strength cannabis

Smoked Cannabis (\~10% THC)

Group Type EXPERIMENTAL

Active Cannabis

Intervention Type DRUG

Smoked cannabis with THC

Interventions

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Active Cannabis

Smoked cannabis with THC

Intervention Type DRUG

Placebo Cannabis

Placebo smoked cannabis (no THC)

Intervention Type DRUG

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Ziva D. Cooper, PhD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ziva Cooper, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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University of California, Los Angeles

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ziva Cooper, PhD

Role: CONTACT

310-206-9942

Vincent Acebo

Role: CONTACT

310-983-3417

Facility Contacts

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Ziva Cooper, Phd

Role: primary

310-206-9942

Vincent Acebo

Role: backup

310-983-3417

Other Identifiers

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R01DA047296

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-000876

Identifier Type: -

Identifier Source: org_study_id

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