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Analgesic and Subjective Effects of Terpenes

About

Brief Summary

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

Primary Purpose
Basic science
Study Type
Interventional
Phase
Phase 1

Eligibility

Gender
All
Healthy Volunteers
Yes
Minimum Age
21 Years
Maximum Age
55 Years

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.

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Study Stats
Protocol No.
19-001519
Category
Healthy Volunteers
Principal Investigator
Ziva Cooper
Contact
Cannabis Lab
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04451863
For detailed technical eligibility, visit ClinicalTrials.gov.