Characterization of Endocannabinoid and Endogenous Opioid Levels in Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Cannabinoid levels in blood
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •14 to 25 years of age.
- •Use cannabis at least twice a week for the past month.
排除标准
- •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.
研究组 & 干预措施
Contingency Management
Abstinence will be rewarded following a contingency management (CM) payment scale.
干预措施: Contingency Management (Behavioral)
结局指标
主要结局
Cannabinoid levels in blood
时间窗: 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
时间窗: Collected at Week 8
We will measure endocannabinoid (eCB) levels AEA and 2-AG, the primary eCBs, in whole blood.
Cannabinoid levels in blood
时间窗: 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
时间窗: 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
时间窗: 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.
Endocannabinoid levels in blood
时间窗: Collected at Baseline
We will measure endocannabinoid (eCB) levels AEA and 2-AG, the primary eCBs, in whole blood.
Endocannabinoid levels in blood
时间窗: Collected at Week 2
We will measure endocannabinoid (eCB) levels AEA and 2-AG, the primary eCBs, in whole blood.
Endocannabinoid levels in blood
时间窗: Collected at Week 4
We will measure endocannabinoid (eCB) levels AEA and 2-AG, the primary eCBs, in whole blood.
次要结局
- Endorphin levels in blood(Collected at Week 8)
- Cannabis Craving(Collected at Week 8)
- Endorphin levels in blood(Collected at Week 2)
- Endorphin levels in blood(Collected at Baseline)
- Endorphin levels in blood(Collected at Week 4)
- Cannabis Craving(Collected at Baseline)
- Cannabis Craving(Collected at Week 2)
- Cannabis Craving(Collected at Week 4)