Characterization of Endocannabinoid and Endogenous Opioid Levels in Adolescents With Cannabis Use Disorder

Not Applicable

Recruiting

• Conditions: Cannabis Use
• Interventions: Behavioral: Contingency Management

• Registration Number: NCT05396638
• Lead Sponsor: University of Colorado, Denver

Brief Summary

This project seeks to learn more about the effects of cannabis use on the endocannabinoid system and endogenous opioid systems in adolescents to address a fundamental gap in knowledge and identify biomarkers that may help distinguish youth who relapse from youth who remain sober.

Detailed Description

Learning the effects of cannabis use on the endocannabinoid system and endogenous opioid systems in adolescents addresses a fundamental gap in knowledge and may identify biomarkers that help distinguish youth who relapse from youth who remain sober.

The specific aims of the project are to:

1. Measure endocannabinoid (eCB) and endogenous opioid (endorphin) levels in the blood of adolescents who use cannabis regularly and adolescents who never use cannabis. We expect eCB and endorphin levels to differ significantly in adolescents who use cannabis regularly compared to adolescents who do not.

2. Characterize circulating eCB and endorphin levels at baseline, during abstinence, and after natural resumption of cannabis use.

3. Collect data to evaluate cannabis craving and to test for association of craving with eCB and endorphin levels in adolescents who use cannabis regularly. We expect that larger changes in eCB and endorphin levels will be associated with higher craving scores.

Study Timeline

• Study First Submitted: 2022-05-16
• Study First Submitted QC: 2022-05-24
• Study First Posted: 2022-05-31
• Study Start: 2022-10-13
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-21
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. 14 to 25 years of age.
2. Use cannabis at least twice a week for the past month.

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Exclusion Criteria

1. Refusal of valid written consent,
2. Current psychosis,
3. Obvious intoxication,
4. Current risk of suicide,
5. Violence sufficiently great to interfere with evaluation or to endanger evaluators,
6. Obvious intellectual deficiency as noted during the informed consent process, or inability of patient or family to comply with the study protocol.
7. Use of other illicit drugs in the past 90 days by self-report or detected by urine drug test.
8. Use of opioid medications for medical or recreational purposes currently or within the past 90 days.
9. Does not have access to an Internet connected devise or cannot use Zoom.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Contingency Management	Contingency Management	Abstinence will be rewarded following a contingency management (CM) payment scale.

Primary Outcome Measures

Name	Time	Method
Cannabinoid levels in blood	Collected at Week 8	Cannabinoid levels in blood: Our primary measure will be 11-nor-carboxy-Δ9-tetrahydrocannabinol (THCCOOH) concentrations in whole blood, which have been demonstrated to be a reliable quantitative measure of cannabis use over the past few weeks35. We will measure an additional 10 cannabinoids \[THC, 11-hydroxy-THC, THC-glucuronide, cannabidiol (CBD), cannabinol (CBN), cannabigerol (CBG), cannabichromene (CBC), cannabidivarin (CBDV), tetrahydro-cannabivarin (THCV), and THCV-COOH\]34, which will be visually inspected to identify potential secondary outcomes.
Endocannabinoid levels in blood	Collected at Week 8	We will measure endocannabinoid (eCB) levels AEA and 2-AG, the primary eCBs, in whole blood.

Secondary Outcome Measures

Name	Time	Method
Endorphin levels in blood	Collected at Week 8	Endorphin levels in blood: Circulating beta Endorphin (b-EP) levels will be quantified using a commercially available enzyme-linked immunosorbent assay (ELISA) kit.
Cannabis Craving	Collected at Week 8	Cannabis craving: The Marijuana Craving Questionnaire (MCQ) will be used to assess cannabis craving.

Trial Locations

Locations (1)

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States