Cannabis UseNCT05396638
Characterization of Endocannabinoid and Endogenous Opioid Levels in Adolescents With Cannabis Use Disorder
A study testing Contingency Management in people with Cannabis Use, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 14 to 25 years
- Conditions the study is for
- Cannabis Use
- What is being tested?
- Contingency Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 14 to 25 years of age.
- Use cannabis at least twice a week for the past month.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: Characterization of Endocannabinoid and Endogenous Opioid Levels in Adolescents
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.
Read the 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.
- Conditions
- Cannabis Use
- Being tested
- Contingency Management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency ManagementBehavioural
Participants will be paid for abstinence at each study visit.
| Study group | Role | What they receive |
|---|---|---|
| Contingency Management | Experimental | Abstinence will be rewarded following a contingency management (CM) payment scale. Receives: Behavioral: Contingency Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Collected at Baseline
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.
Measured: Collected at Week 2
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.
Measured: Collected at Week 4
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.
Measured: Collected at Week 8
Endocannabinoid levels in blood
We will measure endocannabinoid (eCB) levels AEA and 2-AG, the primary eCBs, in whole blood.
Measured: Collected at Baseline
Endocannabinoid levels in blood
We will measure endocannabinoid (eCB) levels AEA and 2-AG, the primary eCBs, in whole blood.
Measured: Collected at Week 2
Endocannabinoid levels in blood
We will measure endocannabinoid (eCB) levels AEA and 2-AG, the primary eCBs, in whole blood.
Measured: Collected at Week 4
Endocannabinoid levels in blood
We will measure endocannabinoid (eCB) levels AEA and 2-AG, the primary eCBs, in whole blood.
Measured: Collected at Week 8
Secondary outcomes (8)
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.
Measured: Collected at Baseline
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.
Measured: Collected at Week 2
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.
Measured: Collected at Week 4
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.
Measured: Collected at Week 8
Cannabis Craving
Cannabis craving: The Marijuana Craving Questionnaire (MCQ) will be used to assess cannabis craving.
Measured: Collected at Baseline
Cannabis Craving
Cannabis craving: The Marijuana Craving Questionnaire (MCQ) will be used to assess cannabis craving.
Measured: Collected at Week 2
Cannabis Craving
Cannabis craving: The Marijuana Craving Questionnaire (MCQ) will be used to assess cannabis craving.
Measured: Collected at Week 4
Cannabis Craving
Cannabis craving: The Marijuana Craving Questionnaire (MCQ) will be used to assess cannabis craving.
Measured: Collected at Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start13 Oct 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis UseStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Colorado Clinical & Translational Sciences Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396638
- Sponsor's protocol ID
- 20-0553
- Status last verified
- Apr 2026
- First submitted
- 16 May 2022
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Endocannabinoid and Endogenous Opioid Levels in Adolescents
- ClinicalTrials.gov ID
- NCT05396638
- Acronym / sponsor ID
- 20-0553
- Conditions
- Cannabis Use
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Colorado Clinical & Translational Sciences Institute
- Study start
- 13 Oct 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Contingency Management | Experimental | Behavioral: Contingency ManagementAbstinence will be rewarded following a contingency management (CM) payment scale. |
Who may qualify
- Ages
- 14 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 14 to 25 years of age.
- Use cannabis at least twice a week for the past month.
Key exclusion criteria (9 listed)
- Refusal of valid written consent,
- Current psychosis,
- Obvious intoxication,
- Current risk of suicide,
- Violence sufficiently great to interfere with evaluation or to endanger evaluators,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contingency ManagementParticipants will be paid for abstinence at each study visit. | Behavioural | Contingency Management |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
8 secondary outcomes
Endorphin levels in blood
Time frame: Collected at Baseline
Endorphin levels in blood
Time frame: Collected at Week 2
Endorphin levels in blood
Time frame: Collected at Week 4
Endorphin levels in blood
Time frame: Collected at Week 8
Cannabis Craving
Time frame: Collected at Baseline
Cannabis Craving
Time frame: Collected at Week 2
Cannabis Craving
Time frame: Collected at Week 4
Cannabis Craving
Time frame: Collected at Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contingency Management in people with Cannabis Use, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cannabinoid levels in blood (time frame: Collected at Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.