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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05396638
Recruitment Status : Recruiting
First Posted : May 31, 2022
Last Update Posted : October 18, 2022
Sponsor:
Collaborator:
Colorado Clinical & Translational Sciences Institute
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cannabis Use Behavioral: Contingency Management Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Characterization of Endocannabinoid and Endogenous Opioid Levels in Adolescents
Actual Study Start Date : October 13, 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05396638


Contacts
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Contact: Jesse Hinckley, MD, PhD 303-724-3090 jesse.hinckley@cuanschutz.edu
Contact: Kristen Raymond, BA 303-724-3196 kristen.raymond@cuanschutz.edu

Locations
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United States, Colorado
University of Colorado Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Jesse Hinckley, MD, PhD    303-724-5690    jesse.hinckley@cuanschutz.edu   
Contact: Kristen Raymond, BA    303-724-3196    kristen.raymond@cuanschutz.edu   
Principal Investigator: Jesse D Hinckley, MD, PhD         
Sponsors and Collaborators
University of Colorado, Denver
Colorado Clinical & Translational Sciences Institute
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT05396638    
Other Study ID Numbers: 20-0553
First Posted: May 31, 2022    Key Record Dates
Last Update Posted: October 18, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders