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AnalgeSiC and appEtite-stimulating Effects of caNnabigerol and THC (ASCENT)

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Brief Summary

This study will assess the analgesic, appetite-stimulating, and subjective effects of cannabigerol (CBG) alone and in combination with 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 and non-lactating females aged 21-55 years
    • Report occasional use of cannabis (cannabis use between ≥ biweekly and ≤ 3 days per week) over the month prior to screening
  • 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)
  • Females must not be lactating

Exclusion Criteria:

  • Meeting DSM-V criteria for moderate-severe Cannabis Use disorder (CUD) or any substance use disorder other than nicotine, caffeine, or mild CUD
  • Any other Axis I disorder
    • Current use of any medications within 14 days or 5 half-lives of administration (whichever is longer) except for hormonal contraceptives in females. If a medication is taken once a participant is enrolled, sessions will be suspended for 14 days or 5 half-lives after administration (whichever is longer)
  • If medical history, physical and psychiatric examination, or laboratory tests performed during the screening process are 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 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
  • 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 are exclusionary, as determined by the evaluating physician
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Study Stats
Protocol No.
21-000208
Category
Healthy Volunteers
Principal Investigator
Ziva Cooper
Contact
Cannabis Lab
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04859296
For detailed technical eligibility, visit ClinicalTrials.gov.