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

Characterization of Endocannabinoid and Endogenous Opioid Levels in Adolescents

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.

Study Overview

• Status: Recruiting
• Conditions: Cannabis Use
• Intervention / Treatment: Behavioral: Contingency Management

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jesse Hinckley, MD, PhD; Phone Number: 303-724-3090; Email: jesse.hinckley@cuanschutz.edu
• Study Contact Backup: Name: Kristen Raymond, BA; Phone Number: 303-724-3196; Email: kristen.raymond@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Anschutz Medical Campus
      • Contact: Jesse Hinckley, MD, PhD; Phone Number: 303-724-5690; Email: jesse.hinckley@cuanschutz.edu
      • Principal Investigator: Jesse D Hinckley, MD, PhD
      • Contact: Kristen Raymond, BA; Phone Number: 303-724-3196; Email: kristen.raymond@cuanschutz.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Contingency Management; Abstinence will be rewarded following a contingency management (CM) payment scale.	Behavioral: Contingency Management; Participants will be paid for abstinence at each study visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endorphin levels in blood	Endorphin levels in blood: Circulating beta Endorphin (b-EP) levels will be quantified using a commercially available enzyme-linked immunosorbent assay (ELISA) kit.	Collected at Baseline
Endorphin levels in blood	Endorphin levels in blood: Circulating beta Endorphin (b-EP) levels will be quantified using a commercially available enzyme-linked immunosorbent assay (ELISA) kit.	Collected at Week 2
Endorphin levels in blood	Endorphin levels in blood: Circulating beta Endorphin (b-EP) levels will be quantified using a commercially available enzyme-linked immunosorbent assay (ELISA) kit.	Collected at Week 4
Endorphin levels in blood	Endorphin levels in blood: Circulating beta Endorphin (b-EP) levels will be quantified using a commercially available enzyme-linked immunosorbent assay (ELISA) kit.	Collected at Week 8
Cannabis Craving	Cannabis craving: The Marijuana Craving Questionnaire (MCQ) will be used to assess cannabis craving.	Collected at Baseline
Cannabis Craving	Cannabis craving: The Marijuana Craving Questionnaire (MCQ) will be used to assess cannabis craving.	Collected at Week 2
Cannabis Craving	Cannabis craving: The Marijuana Craving Questionnaire (MCQ) will be used to assess cannabis craving.	Collected at Week 4
Cannabis Craving	Cannabis craving: The Marijuana Craving Questionnaire (MCQ) will be used to assess cannabis craving.	Collected at Week 8

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Colorado Clinical & Translational Sciences Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: May 16, 2022
• First Submitted That Met QC Criteria: May 24, 2022
• First Posted (Actual): May 31, 2022

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Marijuana Abuse
• Other Study ID Numbers: 20-0553

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No