RECRUITING

Age-dependent Effects of Smoked and Oral Delta-9-THC

Conditions

Pain Abuse, Drug Intoxication; Cannabinoids Cannabis Delta-9-THC Age Sex

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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 age-dependent effects of smoked and oral THC on abuse liability, intoxication, analgesia and impairment as a function of age.

Official Title

Sex- and AGE-dependent Effects of Smoked and Oral Delta-9-THC

Quick Facts

Study Start:2025-03-15

Study Completion:2029-03-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05865470

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:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Male or non-pregnant female aged 18-65 years according to the below criteria: EMERGING ADULTS: 18-25 years of age (+/- one year) MIDDLE-AGED ADULTS: 35-45 years of age (+/- one year) LATE MIDDLE-AGED ADULTS: 55-65 years of age (+/- one year) * Report weekly-monthly use of cannabis (with primary mode of use via inhalation) over the past 6 months prior to screening * Not currently seeking treatment for their cannabis use * No reported clinically significant adverse effects with cannabis use * Have a Body Mass Index from 18.5 - 34kg/m2 * Able to perform all study procedures * FEMALES: Currently practicing an effective form of birth control if pre-menopausal	* Meeting DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5) criteria for any substance use disorder other than nicotine and mild cannabis use disorder * Report using other illicit drugs in the prior 4 weeks * Evidence of severe psychiatric illness (e.g. mood disorder with functional impairment or suicide risk, schizophrenia) or medical condition (i.e., hypertension) judged by the study physician (and PI to put the participant at greater risk of experiencing adverse events due to completion of study procedures, interfere with their ability to participate in the study, or their capacity to provide informed consent. * Current predominant licit use of medical cannabis * Current use of prescription or regular use of over the counter medications (with the exception of hormonal contraceptives and hormone replacement therapy). Current use of herbal supplements that may affect study outcomes or interact with study drug (i.e., St Johns wort, kava, L-tryptophan, melatonin) * 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. * Currently enrolled in another research protocol * Not using a contraceptive method (hormonal or barrier methods) * The evaluating physician reviews all medical assessments along with medical history. Any disorders that might make cannabis administration hazardous are exclusionary. * Intolerance to lactose and sesame (ingredients in the oral THC preparation) * Insensitivity to the Cold Pressor Test

Inclusion Criteria

Exclusion Criteria

* Male or non-pregnant female aged 18-65 years according to the below criteria: EMERGING ADULTS: 18-25 years of age (+/- one year) MIDDLE-AGED ADULTS: 35-45 years of age (+/- one year) LATE MIDDLE-AGED ADULTS: 55-65 years of age (+/- one year)
* Report weekly-monthly use of cannabis (with primary mode of use via inhalation) over the past 6 months prior to screening
* Not currently seeking treatment for their cannabis use
* No reported clinically significant adverse effects with cannabis use
* Have a Body Mass Index from 18.5 - 34kg/m2
* Able to perform all study procedures
* FEMALES: Currently practicing an effective form of birth control if pre-menopausal

* Meeting DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5) criteria for any substance use disorder other than nicotine and mild cannabis use disorder
* Report using other illicit drugs in the prior 4 weeks
* Evidence of severe psychiatric illness (e.g. mood disorder with functional impairment or suicide risk, schizophrenia) or medical condition (i.e., hypertension) judged by the study physician (and PI to put the participant at greater risk of experiencing adverse events due to completion of study procedures, interfere with their ability to participate in the study, or their capacity to provide informed consent.
* Current predominant licit use of medical cannabis
* Current use of prescription or regular use of over the counter medications (with the exception of hormonal contraceptives and hormone replacement therapy). Current use of herbal supplements that may affect study outcomes or interact with study drug (i.e., St Johns wort, kava, L-tryptophan, melatonin)
* 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.
* Currently enrolled in another research protocol
* Not using a contraceptive method (hormonal or barrier methods)
* The evaluating physician reviews all medical assessments along with medical history. Any disorders that might make cannabis administration hazardous are exclusionary.
* Intolerance to lactose and sesame (ingredients in the oral THC preparation)
* Insensitivity to the Cold Pressor Test

Contacts and Locations

Study Contact

Ziva D Cooper, PhD

CONTACT

310-983-3417

zcooper@mednet.ucla.edu

Vincent Acebo

CONTACT

310-983-3417

vacebo@mednet.ucla.edu

Principal Investigator

Ziva Cooper, PhD

PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Study Locations (Sites)

UCLA Center for Cannabis and Cannabinoids

Los Angeles, California, 90095

United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

Ziva 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 Date2025-03-15

Study Completion Date2029-03-15

Study Record Updates

Study Start Date2025-03-15

Study Completion Date2029-03-15

Terms related to this study

Keywords Provided by Researchers

Pain
Cannabis
Delta-9-THC
Age
Sex

Additional Relevant MeSH Terms

Pain
Abuse, Drug
Intoxication; Cannabinoids