Targeting Immune Inflammation in Cocaine Use Disorder: A Human Laboratory Study With Pentoxifylline
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Reinforcing Effects of Cocaine
研究概览
简要总结
This will be a human laboratory study evaluating the influence of pentoxifylline treatment on the effects of cocaine. Supported by and included in the Helping to End Addiction Long-term® (HEAL) Initiative.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •able to speak/read English,
- •not seeking treatment for drug use at the time of the study,
- •female or male between the ages of 18 and 55 years,
- •recent smoked or intravenous cocaine use verified by benzoylecgonine positive urine, as well as fulfillment of DSM-5 diagnostic criteria for CUD,
- •judged to be medically and psychiatrically healthy by study physicians other than the diagnosis for CUD at the time of screening,
- •ECG, read by a cardiologist, within normal limits,
- •females using an effective form of birth control and not pregnant or breastfeeding and 8) no known contraindications or allergies to pentoxifylline.
排除标准
- •unable to speak/read English,
- •seeking treatment for drug use,
- •under 18 years or over 55 years,
- •no recent smoked or intravenous cocaine use as indicated by benzoylecgonine negative urine and no DSM-5 diagnosis of CUD,
- •judged to be medically or psychiatrically unhealthy by study physicians at the time of screening,
- •ECG, read by a cardiologist, outside normal limits,
- •females not using an effective form of birth control or pregnant or breastfeeding,
- •contraindications or allergies to pentoxifylline, and
- •Self-reported history of head trauma, seizure, CNS tumors, or use of concomitant medications that lower seizure threshold, or first-degree family history of seizures.
研究组 & 干预措施
Pentoxifylline Dose 1
Subjects will be treated daily with oral pentoxifylline (1200 mg).
干预措施: Pentoxifylline (Drug)
Pentoxifylline Dose 1
Subjects will be treated daily with oral pentoxifylline (1200 mg).
干预措施: Cocaine (IV) (Drug)
Placebo
Subjects will be treated daily with an oral placebo.
干预措施: Placebo (Drug)
Pentoxifylline Dose 1
Subjects will be treated daily with oral pentoxifylline (1200 mg).
干预措施: Placebo (Drug)
Pentoxifylline Dose 2
Subjects will be treated daily with oral pentoxifylline (1600 mg).
干预措施: Placebo (Drug)
Pentoxifylline Dose 2
Subjects will be treated daily with oral pentoxifylline (1600 mg).
干预措施: Cocaine (IV) (Drug)
Pentoxifylline Dose 2
Subjects will be treated daily with oral pentoxifylline (1600 mg).
干预措施: Pentoxifylline (Drug)
结局指标
主要结局
Reinforcing Effects of Cocaine
时间窗: 9 times over approximately 1 month inpatient admission
Number of Times Subjects Choose Cocaine (Maximum of 5 Choices) Over Money
次要结局
未报告次要终点
研究者
William Stoops
Professor
University of Kentucky