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

Primary Purpose

Cannabis Use

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Contingency Management
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cannabis Use

Eligibility Criteria

14 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Colorado Anschutz Medical CampusRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Contingency Management

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 16, 2022
Last Updated
October 14, 2022
Sponsor
University of Colorado, Denver
Collaborators
Colorado Clinical & Translational Sciences Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05396638
Brief Title
Characterization of Endocannabinoid and Endogenous Opioid Levels in Adolescents With Cannabis Use Disorder
Official Title
Characterization of Endocannabinoid and Endogenous Opioid Levels in Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 13, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Colorado Clinical & Translational Sciences Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Contingency Management
Arm Type
Experimental
Arm Description
Abstinence will be rewarded following a contingency management (CM) payment scale.
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management
Intervention Description
Participants will be paid for abstinence at each study visit.
Primary Outcome Measure Information:
Title
Cannabinoid levels in blood
Description
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.
Time Frame
Collected at Baseline
Title
Cannabinoid levels in blood
Description
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.
Time Frame
Collected at Week 2
Title
Cannabinoid levels in blood
Description
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.
Time Frame
Collected at Week 4
Title
Cannabinoid levels in blood
Description
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.
Time Frame
Collected at Week 8
Title
Endocannabinoid levels in blood
Description
We will measure endocannabinoid (eCB) levels AEA and 2-AG, the primary eCBs, in whole blood.
Time Frame
Collected at Baseline
Title
Endocannabinoid levels in blood
Description
We will measure endocannabinoid (eCB) levels AEA and 2-AG, the primary eCBs, in whole blood.
Time Frame
Collected at Week 2
Title
Endocannabinoid levels in blood
Description
We will measure endocannabinoid (eCB) levels AEA and 2-AG, the primary eCBs, in whole blood.
Time Frame
Collected at Week 4
Title
Endocannabinoid levels in blood
Description
We will measure endocannabinoid (eCB) levels AEA and 2-AG, the primary eCBs, in whole blood.
Time Frame
Collected at Week 8
Secondary Outcome Measure Information:
Title
Endorphin levels in blood
Description
Endorphin levels in blood: Circulating beta Endorphin (b-EP) levels will be quantified using a commercially available enzyme-linked immunosorbent assay (ELISA) kit.
Time Frame
Collected at Baseline
Title
Endorphin levels in blood
Description
Endorphin levels in blood: Circulating beta Endorphin (b-EP) levels will be quantified using a commercially available enzyme-linked immunosorbent assay (ELISA) kit.
Time Frame
Collected at Week 2
Title
Endorphin levels in blood
Description
Endorphin levels in blood: Circulating beta Endorphin (b-EP) levels will be quantified using a commercially available enzyme-linked immunosorbent assay (ELISA) kit.
Time Frame
Collected at Week 4
Title
Endorphin levels in blood
Description
Endorphin levels in blood: Circulating beta Endorphin (b-EP) levels will be quantified using a commercially available enzyme-linked immunosorbent assay (ELISA) kit.
Time Frame
Collected at Week 8
Title
Cannabis Craving
Description
Cannabis craving: The Marijuana Craving Questionnaire (MCQ) will be used to assess cannabis craving.
Time Frame
Collected at Baseline
Title
Cannabis Craving
Description
Cannabis craving: The Marijuana Craving Questionnaire (MCQ) will be used to assess cannabis craving.
Time Frame
Collected at Week 2
Title
Cannabis Craving
Description
Cannabis craving: The Marijuana Craving Questionnaire (MCQ) will be used to assess cannabis craving.
Time Frame
Collected at Week 4
Title
Cannabis Craving
Description
Cannabis craving: The Marijuana Craving Questionnaire (MCQ) will be used to assess cannabis craving.
Time Frame
Collected at Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jesse Hinckley, MD, PhD
Phone
303-724-3090
Email
jesse.hinckley@cuanschutz.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kristen Raymond, BA
Phone
303-724-3196
Email
kristen.raymond@cuanschutz.edu
Facility Information:
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesse Hinckley, MD, PhD
Phone
303-724-5690
Email
jesse.hinckley@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Kristen Raymond, BA
Phone
303-724-3196
Email
kristen.raymond@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Jesse D Hinckley, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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