Effects of Methamphetamine Use on Risk Behavior, Systemic and Mucosal Inflammation, and Sexually Transmitted Infection (STI)/HIV Risk Among Men Who Have Sex With Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Methamphetamine abstinence
研究概览
简要总结
This clinical trial aims to investigate the effects of a decline in methamphetamine use on rectal inflammatory cytokine levels, substance use contexts, and HIV/STI risk behavior. This clinical trial also seeks to evaluate joint effects of methamphetamine use and rectal gonorrhea/chlamydia infection on rectal inflammatory cytokine levels. The proposed trial will consist of 40 MSM, half with rectal gonorrhea/chlamydia infection at enrollment (n=20), with methamphetamine use disorder that will receive contingency management for methamphetamine reduction. Following baseline measurement, participants will be observed over the course of 8 weeks, where participants will complete behavioral surveys, provide urine for drug testing, and rectal samples for measurement of rectal inflammatory cytokine levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Cisgender male
- •18 years of age or older
- •Understand written and spoken English
- •Condomless receptive anal intercourse in past 90 days
- •Meet DSM-5 criteria for methamphetamine use disorder
- •Positive urine toxicology screen for MA metabolites at study entry
- •Negative rectal GC/CT screen (n=20) or Positive rectal GC and/or CT screen (n=20)
- •Able to provide written informed consent and willing/able to complete study visits.
排除标准
- •Reports current treatment for another substance use disorder
- •Positive test for opioids, cocaine, and/or hallucinogens
- •Treatment for gonorrhea and/or chlamydia infection in past 3 months
- •Presence of a condition that in the opinion of the investigator would compromise the safety of the patient or the quality of the data
研究组 & 干预措施
Contingency management
All enrolled participants will participate in a Contingency Management intervention where rewards are linked with demonstrated abstinence from methamphetamine use.
干预措施: Contingency Management (Behavioral)
结局指标
主要结局
Methamphetamine abstinence
时间窗: 8 weeks
Proportion of visits in which there are no detectable methamphetamine metabolites in participant urine samples
Rectal inflammation
时间窗: 8 weeks
Rectal concentrations of IL-6 (pg/mL)
次要结局
未报告次要终点
研究者
Cherie Blair, MD, PhD
Assistant Clinical Professor
University of California, Los Angeles