Clinical trial NCT04451863: Analgesic and Subjective Effects of Terpenes
Official title: Analgesic and Subjective Effects of Terpenes Administered Alone and in Combination with THC
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Pain
Abuse, Drug
Keywords: Cannabis
Analgesia
Pain
THC
Terpenes
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2020-06-30
Enrollment: 45
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this research is to assess the analgesic and subjective effects of terpenes administered alone and in combination of THC.

Detailed description: The overall aim of this placebo-controlled study is to examine dose-dependent analgesia, intoxication, abuse liability, and pharmacokinetics of ecologically relevant doses of vaporized myrcene and beta-caryophyllene administered alone or with vaporized THC.

Eligibility criteria: Inclusion Criteria:

* Male or non-pregnant female aged 21-55 years
* Report non-medical use of cannabis 1-7 days per week over the 1 month prior to screening
* Not currently seeking treatment for cannabis use
* Urine test positive for recent cannabis use
* Have a Body Mass Index from 18.5 - 34kg/m2.
* Able to perform all study procedures
* Must be using a contraceptive method (hormonal or barrier methods)

Exclusion Criteria:

* Meeting DSM-V criteria for any substance use disorder other than nicotine, caffeine, or mild CUD
* Report using other illicit drugs in the prior 4 weeks
* • If medical history, physical and psychiatric examination, or laboratory tests performed during the screening process not within the normal range and / or reveal any significant illness (e.g., hypertension) as judged by the study physician and to put the participant at greater risk of experiencing adverse events due to completion of study procedures.
* Current licit use of cannabis primarily for medical purposes, prescription analgesics, or any medications that may affect study outcomes
* Current pain
* Pregnancy is exclusionary due to the possible effects of the study medication on fetal development.
* History of an allergic reaction or adverse reaction to cannabis is exclusionary.
* History of respiratory illness or current respiratory illness
* History of seizure disorder or current seizure disorder
* Insensitivity to the cold water stimulus of the Cold Pressor Test
* Currently enrolled in another research protocol
* Current major Axis 1 disorders (mood, anxiety, or psychotic disorder)
* Not using a contraceptive method (hormonal or barrier methods)
* The evaluating physician reviews all medical assessments along with medical history. Any disorders that might make cannabis administration hazardous are exclusionary.

Primary outcomes:
measure: Analgesia as measured using the Cold Pressor Test
timeFrame: 7 hours
measure: Subject-rated drug effects of abuse liability
timeFrame: 7 hours
Secondary outcomes:
measure: Subject-rated drug effects of intoxication
timeFrame: 7 hours
measure: Subjective ratings of pain
timeFrame: 7 hours
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Ziva Cooper, PhD
role: PRINCIPAL_INVESTIGATOR
References: