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Active, Not Recruiting

NCT Number: NCT04859296

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pain Abuse, Drug Agnosia Anorexia Appetite Loss Chemically-Induced Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Signs and Symptoms, Digestive Substance-Related Disorders

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of California, Los Angeles

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Vaporized placebo

Low CBG

Drug

Vaporized CBG (5 mg)

High CBG

Drug

Vaporized CBG (15 mg)

Low THC

Drug

Vaporized THC (5 mg)

High THC

Drug

Vaporized THC (15 mg)

Primary outcomes

  1. Analgesia

    Time frame: 7 hours

    Pain threshold and pain tolerance assessed with the Cold Pressor Test - time to report first feeling pain (0-180 seconds) and remove the hand from the cold water (0-180 seconds). Increased duration means increased pain tolerance and pain threshold.

  2. Appetite stimulation

    Time frame: 7 hours

    Subjective ratings of hunger assessed with a visual analog scale (0-100 mm; 0 mm = no effect, 100 mm = maximum possible effect). Higher ratings indicate higher ratings of hunger / appetite stimulation.

  3. Abuse liability

    Time frame: 7 hours

    Subject ratings of "Good Drug Effect" as measured using a visual analog scale (0-100 mm; 0 mm = no effect, 100 mm = maximum possible effect). Higher ratings indicate higher ratings of abuse liability.

Secondary outcomes

  1. Subjective ratings of intoxication

    Time frame: 7 hours

    Subject ratings of "High" as measured using a visual analog scale (0-100 mm; 0 mm = no effect, 100 mm = maximum possible effect). Higher ratings indicate higher ratings of intoxication.

  2. Subjective ratings of pain

    Time frame: 7 hours

    Subject ratings of Painfulness and Bothersomeness of the Cold Pressor Test. Scale is from 0 (Not painful / bothersome at all) to 10 (The most painful / bothersome feeling imaginable), higher ratings indicate greater painfulness and bothersomeness.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Center for Medicinal Cannabis Research

Registry information

Official study title

Analgesic and Appetite-stimulating Effects of Cannabigerol Administered Alone and in Combination With Delta-9-tetrahydrocannabinol

Acronym: ASCENT

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Apr 26, 2021
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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