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

NCT ID: NCT04859296

Last Updated: 2025-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-15

Study Completion Date

2026-12-22

Brief Summary

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

Detailed Description

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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.

Conditions

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Pain Appetite Loss Abuse, Drug

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

0 mg CBG, 0 mg THC

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Vaporized placebo

Low strength CBG

5 mg CBG, 0 mg THC

Group Type ACTIVE_COMPARATOR

Low CBG

Intervention Type DRUG

Vaporized CBG (5 mg)

High strength CBG

15 mg CBG, 0 mg THC

Group Type ACTIVE_COMPARATOR

High CBG

Intervention Type DRUG

Vaporized CBG (15 mg)

Low strength THC

0 mg CBG, 5 mg THC

Group Type ACTIVE_COMPARATOR

Low THC

Intervention Type DRUG

Vaporized THC (5 mg)

High strength THC

0 mg CBG, 30 mg THC

Group Type ACTIVE_COMPARATOR

High THC

Intervention Type DRUG

Vaporized THC (15 mg)

Low strength CBG + Low strength THC

5 mg CBG + 5 mg THC

Group Type ACTIVE_COMPARATOR

Low CBG

Intervention Type DRUG

Vaporized CBG (5 mg)

Low THC

Intervention Type DRUG

Vaporized THC (5 mg)

Low strength CBG + High strength THC

5 mg CBG + 15 mg THC

Group Type ACTIVE_COMPARATOR

Low CBG

Intervention Type DRUG

Vaporized CBG (5 mg)

High THC

Intervention Type DRUG

Vaporized THC (15 mg)

High strength CBG + Low strength THC

15 mg CBG + 5 mg THC

Group Type ACTIVE_COMPARATOR

High CBG

Intervention Type DRUG

Vaporized CBG (15 mg)

Low THC

Intervention Type DRUG

Vaporized THC (5 mg)

High strength CBG + High strength THC

15 mg CBG + 15 mg THC

Group Type ACTIVE_COMPARATOR

High CBG

Intervention Type DRUG

Vaporized CBG (15 mg)

High THC

Intervention Type DRUG

Vaporized THC (15 mg)

Interventions

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Placebo

Vaporized placebo

Intervention Type DRUG

Low CBG

Vaporized CBG (5 mg)

Intervention Type DRUG

High CBG

Vaporized CBG (15 mg)

Intervention Type DRUG

Low THC

Vaporized THC (5 mg)

Intervention Type DRUG

High THC

Vaporized THC (15 mg)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Center for Medicinal Cannabis Research

OTHER

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Ziva D. Cooper, PhD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ziva D Cooper, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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University of California, Los Angeles

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ziva D Cooper, PhD

Role: CONTACT

310-206-9942

Vincent Acebo

Role: CONTACT

310-983-3417

Facility Contacts

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Ziva D Cooper, PhD

Role: primary

310-794-7497

Vincent Acebo

Role: backup

310-983-3417

Other Identifiers

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21-000208

Identifier Type: -

Identifier Source: org_study_id

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