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

• ClinicalTrials.gov Identifier: NCT04859296
• Recruitment Status: Recruiting
• First Posted: April 26, 2021
• Last Update Posted: March 15, 2023
• Sponsor: University of California, Los Angeles
• Collaborator: Center for Medicinal Cannabis Research
• Information provided by (Responsible Party): Ziva D. Cooper, PhD, University of California, Los Angeles

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Pain; Appetite Loss; Abuse, Drug	Drug: Placebo; Drug: Low CBG; Drug: High CBG; Drug: Low THC; Drug: High THC	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: Analgesic and Appetite-stimulating Effects of Cannabigerol Administered Alone and in Combination With Delta-9-tetrahydrocannabinol
• Actual Study Start Date: February 15, 2023
• Estimated Primary Completion Date: December 22, 2024
• Estimated Study Completion Date: December 22, 2025

Arms and Interventions

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 CBG; Vaporized CBG (5 mg); Drug: Low THC; Vaporized THC (5 mg)
Active Comparator: Low strength CBG + High strength THC; 5 mg CBG + 15 mg THC	Drug: Low CBG; Vaporized CBG (5 mg); Drug: High THC; Vaporized THC (15 mg)
Active Comparator: High strength CBG + Low strength THC; 15 mg CBG + 5 mg THC	Drug: High CBG; Vaporized CBG (15 mg); Drug: Low THC; Vaporized THC (5 mg)
Active Comparator: High strength CBG + High strength THC; 15 mg CBG + 15 mg THC	Drug: High CBG; Vaporized CBG (15 mg); Drug: High THC; Vaporized THC (15 mg)

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Gender Eligibility Description: 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.
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Contacts

Contact: Ziva D Cooper, PhD; 310-206-9942; zcooper@mednet.ucla.edu

Contact: Vincent Acebo; 310-983-3417; vacebo@mednet.ucla.edu

Locations

United States, California

University of California, Los Angeles; Recruiting

Los Angeles, California, United States, 90095

Contact: Ziva D Cooper, PhD 310-794-7497 zcooper@mednet.ucla.edu

Contact: Vincent Acebo 310-983-3417 vacebo@mednet.ucla.edu

Principal Investigator: Ziva D Cooper, PhD

Sponsors and Collaborators

University of California, Los Angeles

Center for Medicinal Cannabis Research

Investigators

• Principal Investigator: Ziva D Cooper, PhD; University of California, Los Angeles

More Information

• Responsible Party: Ziva D. Cooper, PhD, Associate Professor, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT04859296
• Other Study ID Numbers: 21-000208
• First Posted: April 26, 2021
• Last Update Posted: March 15, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Ziva D. Cooper, PhD, University of California, Los Angeles:

Analgesia; Pain; Appetite; THC; Cannabigerol; CBG

Additional relevant MeSH terms:

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Dronabinol; Hallucinogens; Physiological Effects of Drugs; Psychotropic Drugs; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Cannabinoid Receptor Agonists; Cannabinoid Receptor Modulators; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists