RECRUITING

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

Conditions

Pain Appetite Loss Abuse, Drug Analgesia Appetite THC Cannabigerol CBG

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-02-15

Study Completion:2026-06-22

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04859296

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Study Contact

Ziva D Cooper, PhD

CONTACT

310-206-9942

zcooper@mednet.ucla.edu

Vincent Acebo

CONTACT

310-983-3417

vacebo@mednet.ucla.edu

Principal Investigator

Ziva D Cooper, PhD

PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Study Locations (Sites)

University of California, Los Angeles

Los Angeles, California, 90095

United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

Ziva D Cooper, PhD, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-15

Study Completion Date2026-06-22

Study Record Updates

Study Start Date2023-02-15

Study Completion Date2026-06-22

Terms related to this study

Keywords Provided by Researchers

Analgesia
Pain
Appetite
THC
Cannabigerol
CBG

Additional Relevant MeSH Terms

Pain
Appetite Loss
Abuse, Drug