NCT06312657终止早期 1 期
Behavioral Effects of Drugs Inpatient 44: Neurobehavioral Mechanisms of Opioid Choice
Joshua A. Lile, Ph.D.1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2023年3月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Task choices
研究概览
简要总结
The objective of this protocol is to use probabilistic choice tasks, reinforcement learning modeling and fMRI to determine the neurobehavioral mechanisms of decision-making in individuals with opioid use disorder and physical opioid dependence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals must meet criteria for moderate/severe opioid use disorder, report past month opioid misuse, and be physically dependent on short-acting opioids (e.g., heroin, hydromorphone, fentanyl), as evidenced by either urine sample positive for recent opioid use during each visit or if opioid negative, displaying frank withdrawal during screening.
- •History of intravenous opioid use.
- •Baseline O2 saturation of 95% or greater.
- •Between the ages of 18-50 years.
- •Female subjects must be using an effective form of birth control (e.g., birth control pills, surgical sterilization, IUD, cervical cap with a spermicide, or abstinence). Urine pregnancy tests will be conducted prior to sessions to ensure that female subjects do not participate if pregnant.
- •Able to speak and read English.
- •Otherwise healthy.
排除标准
- •History of, or current, clinically significant physical disease (e.g., respiratory disease [asthma, COPD, sleep apnea], impaired cardiovascular functioning, seizure disorder or CNS tumors) or current or past history of psychiatric disorder that would limit compliance in the studies, other than substance use disorder.
- •Meet diagnostic criteria for psychoactive substance use disorder for substances other than opioids (OUD subjects only) or nicotine/caffeine that would require detoxification (i.e., alcohol, benzodiazepines or barbiturates). Negative urine/breath samples for these substances, and the absence of withdrawal, will be required during screening.
- •Contraindications for MRI scanning (e.g., pacemaker, metal implants, claustrophobia, or any other implanted medical device).
- •Vision or hearing problems that would preclude completion of experimental tasks.
- •Poor venous access.
- •Regular use of other medications, with the exception of hormone-based contraceptives for female subjects, daily multivitamins or short-term antibiotic prescriptions.
- •At risk for respiratory complications and have predictors of difficult bag mask ventilation (e.g., dentures, very full beard), in case emergency respiratory intervention is needed.
- •Seeking treatment for SUD or currently taking buprenorphine or methadone as the primary opioid of use.
研究组 & 干预措施
Money-vs-money task
Experimental
干预措施: Drug Cue (Behavioral)
Drug-vs-money task
Experimental
干预措施: Money (Behavioral)
Drug-vs-money task
Experimental
干预措施: Withdrawal (Drug)
结局指标
主要结局
Task choices
时间窗: Tasks will take approximately 45-60 minutes to complete. Participants will complete 5 sessions in which a choice task will be administered.
Number of choices of each option selected.
次要结局
未报告次要终点
研究者
Joshua A. Lile, Ph.D.
Professor
University of Kentucky
研究点 (1)
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