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

NCT05396638 | Active Not Recruiting

• 1 other identifier: 20-0553
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cannabis Use

Outcome Measures

Primary Outcomes (8)

• Cannabinoid levels in blood

  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.

  Collected at Baseline

• Cannabinoid levels in blood

  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.

  Collected at Week 2

• Cannabinoid levels in blood

  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.

  Collected at Week 4

• Cannabinoid levels in blood

  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.

  Collected at Week 8

• Endocannabinoid levels in blood

  We will measure endocannabinoid (eCB) levels AEA and 2-AG, the primary eCBs, in whole blood.

  Collected at Baseline

• Endocannabinoid levels in blood

  We will measure endocannabinoid (eCB) levels AEA and 2-AG, the primary eCBs, in whole blood.

  Collected at Week 2

• Endocannabinoid levels in blood

  We will measure endocannabinoid (eCB) levels AEA and 2-AG, the primary eCBs, in whole blood.

  Collected at Week 4

• Endocannabinoid levels in blood

  We will measure endocannabinoid (eCB) levels AEA and 2-AG, the primary eCBs, in whole blood.

  Collected at Week 8

Secondary Outcomes (8)

• Endorphin levels in blood

  Collected at Baseline

• Endorphin levels in blood

  Collected at Week 2

• Endorphin levels in blood

  Collected at Week 4

• Endorphin levels in blood

  Collected at Week 8

• Cannabis Craving

  Collected at Baseline

Study Arms (1)

Contingency Management

EXPERIMENTAL

Abstinence will be rewarded following a contingency management (CM) payment scale.

Behavioral: Contingency Management

Interventions

Contingency Management BEHAVIORAL

Participants will be paid for abstinence at each study visit.

Contingency Management

Eligibility Criteria

• Age: 14 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Colorado Clinical & Translational Sciences Institute: collaborator

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The contingency management (CM) procedure will consist of a four-week abstinence-based incentive program. At the initial visit, participants will be instructed to refrain from using cannabis for the next month and abstinence will be monitored by urine and saliva drug tests. Participants will be paid at each study visit for attendance and abstinence. CM payment rates for abstinence will revert to the initial payment level following a missed study visit or if THC levels rise or are detected by saliva drug screen, respectively.

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 31, 2022
• Study Start: October 13, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)