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

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

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

Study Overview

• Status: Recruiting
• Conditions: Pain; Abuse, Drug; Appetite Loss
• Intervention / Treatment: Drug: Low THC; Drug: High THC; Drug: Placebo; Drug: Low CBG; Drug: High CBG

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Vincent Acebo; Phone Number: 310-983-3417; Email: vacebo@mednet.ucla.edu
• Study Contact Backup: Name: Ziva D Cooper, PhD; Phone Number: 310-206-9942; Email: zcooper@mednet.ucla.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • University of California, Los Angeles
      • Contact: Vincent Acebo; Phone Number: 310-983-3417; Email: vacebo@mednet.ucla.edu
      • Contact: Ziva D Cooper, PhD; Phone Number: 310-794-7497; Email: zcooper@mednet.ucla.edu
      • Principal Investigator: Ziva D Cooper, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 0 mg CBG, 0 mg THC	Drug: Placebo; Vaporized placebo
Active Comparator: Low strength CBG; 5 mg CBG, 0 mg THC	Drug: Low CBG; Vaporized CBG (5 mg)
Active Comparator: High strength CBG; 15 mg CBG, 0 mg THC	Drug: High CBG; Vaporized CBG (15 mg)
Active Comparator: Low strength THC; 0 mg CBG, 5 mg THC	Drug: Low THC; Vaporized THC (5 mg)
Active Comparator: High strength THC; 0 mg CBG, 30 mg THC	Drug: High THC; Vaporized THC (15 mg)
Active Comparator: Low strength CBG + Low strength THC; 5 mg CBG + 5 mg THC	Drug: Low THC; Vaporized THC (5 mg); Drug: Low CBG; Vaporized CBG (5 mg)
Active Comparator: Low strength CBG + High strength THC; 5 mg CBG + 15 mg THC	Drug: High THC; Vaporized THC (15 mg); Drug: Low CBG; Vaporized CBG (5 mg)
Active Comparator: High strength CBG + Low strength THC; 15 mg CBG + 5 mg THC	Drug: Low THC; Vaporized THC (5 mg); Drug: High CBG; Vaporized CBG (15 mg)
Active Comparator: High strength CBG + High strength THC; 15 mg CBG + 15 mg THC	Drug: High THC; Vaporized THC (15 mg); Drug: High CBG; Vaporized CBG (15 mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: Center for Medicinal Cannabis Research
• Investigators: Principal Investigator: Ziva D Cooper, PhD, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2023
• Primary Completion (Anticipated): December 22, 2024
• Study Completion (Anticipated): December 22, 2025

Study Registration Dates

• First Submitted: April 21, 2021
• First Submitted That Met QC Criteria: April 21, 2021
• First Posted (Actual): April 26, 2021

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Pain; Analgesia; THC; Appetite; Cannabigerol; CBG
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Psychotropic Drugs; Hallucinogens; Cannabinoid Receptor Agonists; Cannabinoid Receptor Modulators; Dronabinol
• Other Study ID Numbers: 21-000208

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No