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

Cannabis Use Clinical Trial

Official title:

Characterization of Endocannabinoid and Endogenous Opioid Levels in Adolescents

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05396638
• Other study ID #: 20-0553
• Status: Recruiting
• Phase: N/A
• Start date: October 13, 2022
• Est. completion date: June 2024

Study information

• Verified date: January 2024
• Source: University of Colorado, Denver
• Contact: Jesse Hinckley, MD, PhD
• Phone: 303-724-3090
• Email: jesse.hinckley[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cannabis Use
• Marijuana Abuse

Intervention

Behavioral:
• Contingency Management
Participants will be paid for abstinence at each study visit.

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Colorado Clinical & Translational Sciences Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cannabinoid levels in blood	Cannabinoid levels in blood: Our primary measure will be 11-nor-carboxy-?9-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
Primary	Cannabinoid levels in blood	Cannabinoid levels in blood: Our primary measure will be 11-nor-carboxy-?9-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
Primary	Cannabinoid levels in blood	Cannabinoid levels in blood: Our primary measure will be 11-nor-carboxy-?9-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
Primary	Cannabinoid levels in blood	Cannabinoid levels in blood: Our primary measure will be 11-nor-carboxy-?9-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
Primary	Endocannabinoid levels in blood	We will measure endocannabinoid (eCB) levels AEA and 2-AG, the primary eCBs, in whole blood.	Collected at Baseline
Primary	Endocannabinoid levels in blood	We will measure endocannabinoid (eCB) levels AEA and 2-AG, the primary eCBs, in whole blood.	Collected at Week 2
Primary	Endocannabinoid levels in blood	We will measure endocannabinoid (eCB) levels AEA and 2-AG, the primary eCBs, in whole blood.	Collected at Week 4
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Cannabis Craving	Cannabis craving: The Marijuana Craving Questionnaire (MCQ) will be used to assess cannabis craving.	Collected at Baseline
Secondary	Cannabis Craving	Cannabis craving: The Marijuana Craving Questionnaire (MCQ) will be used to assess cannabis craving.	Collected at Week 2
Secondary	Cannabis Craving	Cannabis craving: The Marijuana Craving Questionnaire (MCQ) will be used to assess cannabis craving.	Collected at Week 4
Secondary	Cannabis Craving	Cannabis craving: The Marijuana Craving Questionnaire (MCQ) will be used to assess cannabis craving.	Collected at Week 8