Cannabis Effects as a Function of Sex (CanSex)

University of California, Los Angeles (UCLA)

Status and phase: Enrolling; Phase 1

Conditions: Abuse, Drug; Pain

Treatments: Drug: Placebo Cannabis; Drug: Active Cannabis

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04385082

19-000876

R01DA047296 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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160 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Smoked Cannabis (\~0% THC)

Treatment:

Drug: Placebo Cannabis

Low strength cannabis

Experimental group

Description:

Smoked Cannabis (\~4% THC)

Treatment:

Drug: Active Cannabis

Higher strength cannabis

Experimental group

Description:

Smoked Cannabis (\~10% THC)

Treatment:

Drug: Active Cannabis