NCT06989853招募中1 期
Advancing Troiluzole as a Treatment for Methamphetamine Use Disorder: A Human Laboratory Study
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Reinforcing Effects of Methamphetamine
研究概览
简要总结
This will be a human laboratory study evaluating the influence of troriluzole treatment on the effects of methamphetamine. 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
- Double (Participant, 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
- 否
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 methamphetamine use verified by methamphetamine positive urine, as well as fulfillment of DSM-5 diagnostic criteria for MUD,
- •judged to be medically and psychiatrically healthy by study physicians other than the diagnosis for MUD (and OUD for the co-morbid MUD and OUD group, see below) 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,
- •no known contraindications (e.g., hepatic disease [save for asymptomatic HCV status as cleared by study physician]) or allergies to troriluzole. Individuals in the MUD and OUD group must also report recent opioid use, verified by opioid positive urine, as well as fulfillment of DSM-5 diagnostic criteria for OUD with physiologic dependence (determined to not be physically dependent if a participant arrives with a urine sample for drug screening that is negative for a short-acting opioid and does not have a score of 5 or greater on the clinical opioid withdrawal scale [COWS]).
排除标准
- •unable to speak/read English,
- •seeking treatment for drug use,
- •under 18 years or over 55 years,
- •no recent methamphetamine use as indicated by methamphetamine negative urine and no DSM-5 diagnosis of MUD,
- •judged to be medically and 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,
- •blood pressure readings indicative of hypertension (i.e., blood pressure > 140/90 mmHg) on 2 consecutive screening visits,
- •BMI < 18 or > 30; weight < 50 kg,
- •taking any medications prescribed by a physician for a chronic condition,
- •any laboratory chemistry values (e.g., LFTs) > 3 times normal at screening or during admission,
- •history of serious physical disease or diagnosis of any disorder (e.g., current hepatic disease [save for asymptomatic HCV status; as noted above], histories of seizure, diabetes, asthma or CNS tumors) or current or past histories of psychiatric disorder, including current or recent suicidal ideation that would limit compliance in the study, other than MUD or tobacco use disorder (and OUD for the co-morbid MUD/OUD group only) that in the opinion of the study physicians would interfere with participation and
- •contraindications (e.g., hepatic disease) or allergies to troriluzole.
研究组 & 干预措施
Placebo
Placebo Comparator
Subjects will be treated daily with an oral placebo.
干预措施: Placebo (Drug)
Troriluzole Dose 1
Experimental
Subjects will be treated daily with oral troriluzole (140 mg).
干预措施: Placebo (Drug)
Troriluzole Dose 2
Experimental
Subjects will be treated daily with oral troriluzole (280 mg).
干预措施: Placebo (Drug)
Troriluzole Dose 1
Experimental
Subjects will be treated daily with oral troriluzole (140 mg).
干预措施: Methamphetamine (Drug)
Troriluzole Dose 2
Experimental
Subjects will be treated daily with oral troriluzole (280 mg).
干预措施: Methamphetamine (Drug)
结局指标
主要结局
Reinforcing Effects of Methamphetamine
时间窗: 9 times over approximately 1 month inpatient admission
Number of Times Subjects Hypothetically Choose Methamphetamine Over Money between $0 and $140
次要结局
未报告次要终点
研究者
William Stoops
Professor
University of Kentucky
研究点 (2)
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