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

Last updated: July 24, 2024
Sponsor: University of California, Los Angeles
Overall Status: Active - Recruiting

Phase

1

Condition

Opioid Use Disorder

Stimulant Use Disorder

Pain

Treatment

High THC

Low CBG

Low THC

Clinical Study ID

NCT04859296
21-000208
  • Ages 21-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This study will assess the analgesic, appetite-stimulating, and subjective effects of cannabigerol (CBG) alone and in combination with THC.

Eligibility Criteria

Inclusion

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 daysper 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

Exclusion Criteria:

  • Meeting DSM-V criteria for moderate-severe Cannabis Use disorder (CUD) or anysubstance 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 medicationis taken once a participant is enrolled, sessions will be suspended for 14 days or 5half-lives after administration (whichever is longer)

  • If medical history, physical and psychiatric examination, or laboratory testsperformed during the screening process are not within the normal range and / orreveal any significant illness (e.g., hypertension) as judged by the study physicianand to put the participant at greater risk of experiencing adverse events due tocompletion of study procedures.

  • Current pain

  • Pregnancy is exclusionary due to the possible effects of the study medication onfetal 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, asdetermined by the evaluating physician

Study Design

Total Participants: 20
Treatment Group(s): 5
Primary Treatment: High THC
Phase: 1
Study Start date:
February 15, 2023
Estimated Completion Date:
June 22, 2026

Study Description

The overall aim of this double-blind, placebo-controlled, within-subject study in healthy, occasional cannabis smokers is to ascertain the dose-dependent analgesic and appetite-stimulating effects of ecologically relevant doses of cannabigerol (CBG) alone and in combination with a sub-analgesic / sub-appetite stimulating, minimally psychoactive dose of THC and an analgesic, appetite-stimulating, but intoxicating dose of THC.

Connect with a study center

  • University of California, Los Angeles

    Los Angeles, California 90095
    United States

    Active - Recruiting

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