Neurobehavioral Mechanisms of Choice in Opioid Use Disorder
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Gambling task
研究概览
简要总结
The objective of this protocol is to use probabilistic reinforcement learning choice tasks and magnetic resonance neuroimaging to demonstrate the impact of problematic opioid use and opioid withdrawal on dynamic decision-making and reveal the neurobehavioral and neurobiological processes underlying abnormal task performance. A second objective is to identify an appropriate dose of intravenous remifentanil for subsequent studies in physically dependent individuals with opioid use disorder.
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)
盲法说明
Double-blind
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
- •Must meet moderate/severe criteria for moderate/severe opioid use disorder, report recent prescription or illicit opioid use, and be opioid dependent, as evidenced by either a urine sample positive for recent opioid use or being in frank withdrawal during screening.
- •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).
- •Able to speak and read English
- •Subjects who are interested in completing the remifentanil dose-ranging session must report a history of intravenous opioid use and a baseline O2 saturation of 95% or greater.
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 that would require detoxification (i.e., alcohol, benzodiazepines or barbiturates).
- •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.
- •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.
- •Poor venous access (only subjects who will participate in the remifentanil dose-ranging session).
研究组 & 干预措施
Withdrawal
Subjects complete a probabilistic money-vs-money choice task during opioid withdrawal induced via double-blind substitution of placebo for active oxycodone in maintenance capsules.
干预措施: Oxycodone (Drug)
Oxycodone
Subjects complete a probabilistic money-vs-money choice task during oxycodone maintenance.
干预措施: Oxycodone (Drug)
结局指标
主要结局
Gambling task
时间窗: Change in monetary rewards earned on a gambling task as a function of the intervention will be assessed by administering this task once per session across two sessions during a 9-day inpatient enrollment in each subject
The number of monetary rewards earned on a gambling task, in which two options signaled by distinct cues are presented on a computer screen and choosing either could result in the delivery of money, but the reinforcement probabilities of the options differ, and change during the task.
Probabilistic Money vs Money Choice Task
时间窗: Subjects complete the task twice; once under opioid maintained and once under opioid withdrawn conditions during a 16-day inpatient participation. The task takes approximately 20 minutes to complete each time.
Subjects completed a 300-trial probabilistic concurrent monetary choice task, also known as an n-bandit task (here, n=2 choice options, with unsigned probability reversals every 50 trials). In each trial, subjects chose between two options signaled by blue and green envelopes. When a reward was scheduled for the chosen option, subjects were notified they earned $0.25 USD; task earnings were provided upon session completion. Choice of the high probability option was more likely to be reinforced than the low probability option at a 6:1 ratio, with probabilities summing to 0.3, resulting in a low reinforcement density context. Because choosing the higher probability option is associated with a higher likelihood of receiving a monetary reinforcer, making more high probability choices is considered better performance on the task.
次要结局
未报告次要终点
研究者
Joshua A. Lile, Ph.D.
Professor
University of Kentucky