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

NCT04859296 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: 21-000208
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain; Appetite Loss; Abuse, Drug

Keywords

Analgesia; Pain; Appetite; THC; Cannabigerol; CBG

Outcome Measures

Primary Outcomes (3)

• Analgesia

  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.

  7 hours

• Appetite stimulation

  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.

  7 hours

• Abuse liability

  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.

  7 hours

Secondary Outcomes (2)

• Subjective ratings of intoxication

  7 hours

• Subjective ratings of pain

  7 hours

Study Arms (9)

Placebo

PLACEBO COMPARATOR

0 mg CBG, 0 mg THC

Drug: Placebo

Low strength CBG

ACTIVE COMPARATOR

5 mg CBG, 0 mg THC

Drug: Low CBG

High strength CBG

ACTIVE COMPARATOR

15 mg CBG, 0 mg THC

Drug: High CBG

Low strength THC

ACTIVE COMPARATOR

0 mg CBG, 5 mg THC

Drug: Low THC

High strength THC

ACTIVE COMPARATOR

0 mg CBG, 30 mg THC

Drug: High THC

Low strength CBG + Low strength THC

ACTIVE COMPARATOR

5 mg CBG + 5 mg THC

Drug: Low CBG; Drug: Low THC

Low strength CBG + High strength THC

ACTIVE COMPARATOR

5 mg CBG + 15 mg THC

Drug: Low CBG; Drug: High THC

High strength CBG + Low strength THC

ACTIVE COMPARATOR

15 mg CBG + 5 mg THC

Drug: High CBG; Drug: Low THC

High strength CBG + High strength THC

ACTIVE COMPARATOR

15 mg CBG + 15 mg THC

Drug: High CBG; Drug: High THC

Interventions

Placebo DRUG

Vaporized placebo

Placebo

Low CBG DRUG

Vaporized CBG (5 mg)

Low strength CBG; Low strength CBG + High strength THC; Low strength CBG + Low strength THC

High CBG DRUG

Vaporized CBG (15 mg)

High strength CBG; High strength CBG + High strength THC; High strength CBG + Low strength THC

Low THC DRUG

Vaporized THC (5 mg)

High strength CBG + Low strength THC; Low strength CBG + Low strength THC; Low strength THC

High THC DRUG

Vaporized THC (15 mg)

High strength CBG + High strength THC; High strength THC; Low strength CBG + High strength THC

Eligibility Criteria

• Age: 21 Years - 55 Years
• Gender Eligibility Details: Prospective research participants will be healthy, occasional (cannabis use biweekly to ≤ 3 day per week) cannabis-using men and non-pregnant and non-lactating women who will be evaluated for participation according to the following inclusion/exclusion criteria.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Center for Medicinal Cannabis Research: collaborator

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Pain; Anorexia; Substance-Related Disorders; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Chemically-Induced Disorders; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Ziva D Cooper, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 26, 2021
• Study Start: February 15, 2023
• Primary Completion: December 4, 2025
• Study Completion (Estimated): December 4, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)