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

Sponsor

University of California, Los Angeles (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04859296

Collaborator

Center for Medicinal Cannabis Research (Other)

Enrollment

Location

Arms

33.4

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

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

Anticipated 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.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

Anticipated Study Start Date :

Jun 20, 2022

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Apr 1, 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

Analgesia [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.
Appetite stimulation [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.
Abuse liability [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

Subjective ratings of intoxication [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.
Subjective ratings of pain [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

Criteria

Ages Eligible for Study:

21 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Male or non-pregnant and non-lactating females aged 21-55 years
Report monthly use of cannabis (≤1 day per week) over the 6 months 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)

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
Report using other illicit drugs in the prior 4 weeks
Current use of prescription analgesics, or any medications that may affect study outcomes
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