INTERVENTIONALACTIVE NOT RECRUITINGNCT04385082

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

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-07-06

What this record can show

Protocol only - no registry results posted

This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.

Registry facts

Study at a glance

Phase: PHASE1
Enrollment: 160 (ESTIMATED)
Start date: 2021-07-08
Sponsor: University of California, Los Angeles
Design: RANDOMIZED · CROSSOVER · BASIC SCIENCE
Locations: 1
Results record: Not present in registry snapshot

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.

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

No published condition report matched.

Cannabinoids and active compounds

No governed compound link was found.

Medicines

No exact medicine-name link was found.

Interventions

What was registered

DRUG

Active Cannabis

Smoked cannabis with THC

DRUG

Placebo Cannabis

Placebo smoked cannabis (no THC)

Eligibility

Population and criteria

Sex: ALL
Minimum age: 21 Years
Maximum age: 55 Years
Healthy volunteers: Accepted

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

primary outcomes

primary measures

Subject-rated drug effects

Time frame: 5 hours

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

Time frame: 5 hours

Peak and average pain threshold and tolerance assessed using the Cold Pressor Test

Pharmacokinetics of THC and metabolites

Time frame: 5 hours

Plasma levels of THC, 11-OH-THC, and THCCOOH

secondary outcomes

secondary measures

Drug reinforcement using the cannabis self-administration task

Time frame: 5 hours

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.

Publications

Locally readable linked articles

No exact PMID-linked public article is currently readable locally.

Snapshot provenance

Snapshot: 9e9454c4-a0b4-4f26-a8c6-767711984b0d
Retrieved: 11/09/2026, 14:54:46
SHA-256: e4e7a0389d728c34966a9b525e2201afcecffc0d90f04609798086993132b8ca