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NCT Number: NCT05396638

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Cannabis Use

Age range

14 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Contingency Management

Behavioral

Participants will be paid for abstinence at each study visit.

Primary outcomes

  1. Cannabinoid levels in blood

    Time frame: Collected at Baseline

    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.

  2. Cannabinoid levels in blood

    Time frame: Collected at Week 2

    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.

  3. Cannabinoid levels in blood

    Time frame: Collected at Week 4

    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.

  4. Cannabinoid levels in blood

    Time frame: 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.

  5. Endocannabinoid levels in blood

    Time frame: Collected at Baseline

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

  6. Endocannabinoid levels in blood

    Time frame: Collected at Week 2

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

  7. Endocannabinoid levels in blood

    Time frame: Collected at Week 4

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

  8. Endocannabinoid levels in blood

    Time frame: Collected at Week 8

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

Secondary outcomes

  1. Endorphin levels in blood

    Time frame: Collected at Baseline

    Endorphin levels in blood: Circulating beta Endorphin (b-EP) levels will be quantified using a commercially available enzyme-linked immunosorbent assay (ELISA) kit.

  2. Endorphin levels in blood

    Time frame: Collected at Week 2

    Endorphin levels in blood: Circulating beta Endorphin (b-EP) levels will be quantified using a commercially available enzyme-linked immunosorbent assay (ELISA) kit.

  3. Endorphin levels in blood

    Time frame: Collected at Week 4

    Endorphin levels in blood: Circulating beta Endorphin (b-EP) levels will be quantified using a commercially available enzyme-linked immunosorbent assay (ELISA) kit.

  4. Endorphin levels in blood

    Time frame: 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.

  5. Cannabis Craving

    Time frame: Collected at Baseline

    Cannabis craving: The Marijuana Craving Questionnaire (MCQ) will be used to assess cannabis craving.

  6. Cannabis Craving

    Time frame: Collected at Week 2

    Cannabis craving: The Marijuana Craving Questionnaire (MCQ) will be used to assess cannabis craving.

  7. Cannabis Craving

    Time frame: Collected at Week 4

    Cannabis craving: The Marijuana Craving Questionnaire (MCQ) will be used to assess cannabis craving.

  8. Cannabis Craving

    Time frame: Collected at Week 8

    Cannabis craving: The Marijuana Craving Questionnaire (MCQ) will be used to assess cannabis craving.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Colorado Clinical & Translational Sciences Institute

Registry information

Official study title

Characterization of Endocannabinoid and Endogenous Opioid Levels in Adolescents

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 31, 2022
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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