Abuse Cannabis, Pain, Pharmacokinetics
Conditions
Keywords
THC, Cannabis
Brief summary
The purpose of this research is to assess the effects of smoked cananbis when cannabis is smoked during periods of cannabis use as usual and after a brief period of abstinence.
Detailed description
This outpatient study will assess the acute pharmacodynamic effects of smoked cannabis with \ 50 mg and \ 100 mg THC compared to placebo (\ 0 mg THC) and whether a brief period of abstinence alters these effects. Metabolism (pharmacokinetics) of THC will be examined to associate behavioral and physiological effects to plasma concentrations of THC and metabolites.
Interventions
Sponsors
California Department of Cannabis Control (DCC)
University of California, Los Angeles
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 and non-lactating females aged 21-55 years * Report cannabis smoking near daily * Not currently seeking treatment for their cannabis use * Have a Body Mass Index from 18.5 - 34kg/m2. * Able to perform all study procedures * Must be using a contraceptive (hormonal or barrier methods)
Exclusion criteria
* Meeting DSM-V criteria for any substance use disorder other than cannabis, nicotine, caffeine * Do not have positive urine toxicology for cannabis use during screening * Evidence of severe psychiatric illness (e.g. mood or anxiety disorder with functional impairment or suicide risk, schizophrenia) 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. * Report using other illicit drugs in the prior 4 weeks * Current predominant licit use of medical cannabis, prescription analgesics, or any medications that may affect study outcomes * Current pain * Pregnancy * Currently enrolled in another research protocol * Not using a contraceptive method (hormonal or barrier methods) * Insensitivity to the cold water stimulus of the Cold Pressor Test * Any disorders that might make cannabis administration hazardous as determined by evaluation physician after review of all medical assessments along with medical history. * Not able to speak and read English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject-rated drug effects of abuse liability | 3 hours | Subject ratings of Good Drug Effect as measured using a visual analog scale (1-100 mm) |
| Analgesia as measured using the Cold Pressor Test | 3 hours | Pain threshold assessed using the Cold Pressor Test (percent baseline) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of THC and metabolites | 3 hours | Peak plasma levels of THC (ng/ml) |
Countries
United States
Contacts
Primary ContactZiva Cooper, PhD
Backup ContactVincent Acebo
Outcome results
None listed