Abuse, Drug, Pain
Conditions
Keywords
Pain, Cannabis, THC
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.
Interventions
DRUGActive Cannabis
Smoked cannabis with THC
DRUGPlacebo Cannabis
Placebo smoked cannabis (no THC)
Sponsors
University of California, Los Angeles
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Intervention model description
This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject-rated drug effects | 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 | 5 hours | Peak and average pain threshold and tolerance assessed using the Cold Pressor Test |
| Pharmacokinetics of THC and metabolites | 5 hours | Plasma levels of THC, 11-OH-THC, and THCCOOH |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Drug reinforcement using the cannabis self-administration task | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORZiva Cooper, PhD
University of California, Los Angeles
Outcome results
None listed