Feasibility and Impact of 28-days of Monitored Abstinence From Cannabis Use on Symptoms of Distress, Inflammation, and HIV Viral Load
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- Sustained cannabis abstinence for 28-days
研究概览
简要总结
The purpose of this study is to determine the feasibility and impact of 28-days of monitored abstinence from cannabis use on symptoms of depression and anxiety, pain, sleep, cannabis use withdrawal, HIV viral load and biomarkers of systemic inflammation among PLWH and who use cannabis regularly (weekly or more often). This will be a single arm pilot feasibility trial involving a contingency management program to induce cannabis abstinence. Specifically, the contingency management program will provide motivational (monetary) incentives to participants who achieve biochemically verified cannabis abstinence. Over the 28-days of this pilot feasibility trial, participants will attend seven study visits. During these visits, participants will complete survey questionnaires to assess sociodemographic, psychosocial, and behavioral factors. In addition, participants will provide blood and urine specimens for testing and quantitation of HIV viral load, biomarkers of systemic inflammation and for the detection of cannabis and other drugs of abuse.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-positive (confirmed via HIV medication or relevant HIV labs in subject's name)
- •Self-report of cannabis use at least once per week in the 6-month period prior to consent
- •Provide a positive urine toxicology (UTOX) screen for cannabis
- •Not seeking treatment for cannabis use
- •Willing to stop using cannabis for 28 days and attend eight study visits over six weeks.
- •Ability and willingness to provide inform consent
- •English fluency
排除标准
- •Currently receiving treatment for cannabis or other drug use disorder
- •Diagnosed or receiving treatment for a current major depressive or anxiety disorder
- •Diagnosed with any current alcohol or substance use disorder (excluding nicotine) using the Structured Clinical Interview for Clinical Disorders (SCID) Interview (22)
- •Positive UTOX screen for opioids
- •Having a medical, psychiatric, occupational, or other condition that, in the judgment of the study physician, would make participation difficult or unsafe.
结局指标
主要结局
Sustained cannabis abstinence for 28-days
时间窗: 28-days
Cannabis abstinence will be defined as sustained reduction in quantitative levels of 11-Nor-9-carboxy-Δ⁹-tetrahydrocannabinol (THCCOOH) for 28-days
次要结局
未报告次要终点
研究者
Chukwuemeka Okafor
Assistant Professor
The University of Texas Health Science Center at San Antonio