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

Pain Clinical Trial

— ASCENT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04859296
• Other study ID #: 21-000208
• Status: Recruiting
• Phase: Phase 1
• Start date: February 15, 2023
• Est. completion date: December 22, 2025

Study information

• Verified date: March 2023
• Source: University of California, Los Angeles
• Contact: Ziva D Cooper, PhD
• Phone: 310-206-9942
• Email: zcooper[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 22, 2025
• Est. primary completion date: December 22, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Abuse, Drug
• Appetite Loss
• Pain
• Substance-Related Disorders

Intervention

Drug:
• Placebo
Vaporized placebo
• Low CBG
Vaporized CBG (5 mg)
• High CBG
Vaporized CBG (15 mg)
• Low THC
Vaporized THC (5 mg)
• High THC
Vaporized THC (15 mg)

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	Center for Medicinal Cannabis Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Subjective ratings of intoxication	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.	7 hours
Secondary	Subjective ratings of pain	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.	7 hours