Clinical trial NCT05396638: 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
Overall status: RECRUITING
Phase: NA
Conditions: Cannabis Use
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Colorado Clinical & Translational Sciences Institute
First posted: 2022-05-31
Enrollment: 30
Sex: ALL
Minimum age (years): 14
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: OTHER

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:

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.

Eligibility 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.

Primary outcomes:
measure: Cannabinoid levels in blood
timeFrame: Collected at Baseline
measure: Cannabinoid levels in blood
timeFrame: Collected at Week 2
measure: Cannabinoid levels in blood
timeFrame: Collected at Week 4
measure: Cannabinoid levels in blood
timeFrame: Collected at Week 8
measure: Endocannabinoid levels in blood
timeFrame: Collected at Baseline
measure: Endocannabinoid levels in blood
timeFrame: Collected at Week 2
measure: Endocannabinoid levels in blood
timeFrame: Collected at Week 4
measure: Endocannabinoid levels in blood
timeFrame: Collected at Week 8
Secondary outcomes:
measure: Endorphin levels in blood
timeFrame: Collected at Baseline
measure: Endorphin levels in blood
timeFrame: Collected at Week 2
measure: Endorphin levels in blood
timeFrame: Collected at Week 4
measure: Endorphin levels in blood
timeFrame: Collected at Week 8
measure: Cannabis Craving
timeFrame: Collected at Baseline
measure: Cannabis Craving
timeFrame: Collected at Week 2
measure: Cannabis Craving
timeFrame: Collected at Week 4
measure: Cannabis Craving
timeFrame: Collected at Week 8
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
References: