The Effect of Chronic Pain on Delay Discounting in Methadone Patients
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Delay Discounting of Money Rate (k)
研究概览
简要总结
The epidemic of opioid overdose deaths continues to rise, killing more persons in 2017 than HIV/AIDS at the height of that epidemic. Medication assisted treatment, including methadone and buprenorphine, is the standard of care for the treatment of opioid use disorder (OUD). However, chronic pain can reduce treatment efficacy during medication assisted treatment and is associated with illicit substance relapse, dropout, and subsequent overdose. Mechanisms by which chronic pain may influence the impulsive decision making (e.g., drug relapse) in persons with OUD have not been well characterized. A better understanding is needed of decision-making in this population. Two factors that can influence decisions to use drugs are impulsivity and acute opioid withdrawal. This proposal will test how chronic pain is associated with increases in impulsive decision making in OUD, whether impulsive decision making is greater when undergoing opioid withdrawal, and how catastrophizing may modify the association between withdrawal and impulsive decision making in patients with chronic pain and OUD. An ideal population for this developmental research project are methadone maintained patients, who show high treatment attendance rates and will therefore assure study efficiency and reliable completion.
详细描述
This is an outpatient Phase 1 clinical trial investigating the effect of naloxone precipitated withdrawal on delay discounting. Eligible participants will undergo two experimental sessions presented in random order. One session will involve the measurement of delay discounting 30 minutes after double-blind intramuscular (IM) administration of placebo (normal saline) and the other will have the exact same procedures performed after double-blind IM administration of naloxone (0.1 mg). Injections will occur 2 hours after methadone dosing (peak levels). Study sessions will last 2 hours and involve pain and opioid withdrawal measures assessed at baseline and 15 minute intervals after injections. The participant should be back to baseline and free of withdrawal by the end of the study session. Sessions will occur at least 48 hours apart.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The participant, investigator, medical personnel administering study drug, and outcomes assessor will be blinded to drug being administered.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female adults aged 18-65
- •Stable methadone dose (at least 21 days) verified by contacting participant's opioid treatment program
- •Understand and speak English
- •Urine toxicology screen negative for drugs of abuse and positive for methadone
- •Participants must be without signs of intoxication as evidenced by ability to receive full dose of methadone prior to research activities.
- •Presence of chronic pain (>3 months) for the Pain group and absence of pain for the No Pain group.
排除标准
- •Unstable psychiatric illness as assessed by the Mini International Neuropsychiatric Interview (e.g. active suicidal ideation, psychosis)
- •Unstable medical illness as assessed by the study's independent medical monitor (e.g. uncontrolled hypertension, recent myocardial infarction, recent stroke, unstable angina) that may be affected by precipitated withdrawal
- •Prescription opioid use besides methadone
- •Acute pain process unrelated to chronic pain
- •Women who are pregnant or lactating
- •Known allergy to naloxone
研究组 & 干预措施
Pain Group
Patients with chronic pain who are maintained on methadone for opioid use disorder
干预措施: Naloxone Hydrochloride (Drug)
Pain Group
Patients with chronic pain who are maintained on methadone for opioid use disorder
干预措施: Placebo (Drug)
No Pain Group
Patients who are maintained on methadone for opioid use disorder but who do not have chronic pain.
干预措施: Naloxone Hydrochloride (Drug)
No Pain Group
Patients who are maintained on methadone for opioid use disorder but who do not have chronic pain.
干预措施: Placebo (Drug)
结局指标
主要结局
Delay Discounting of Money Rate (k)
时间窗: k will be calculated from the same series of discounting questions that will be asked once each session at approximately 30 minutes after study medication administration.
Delay discounting is the relative preference for smaller sooner over larger later rewards, an aspect of impulsivity. Most individuals would prefer an immediate $100 over $100 delayed by 1 year. However, when faced with the choice between receiving $95 now versus $100 in 1 year, preferences for the delayed reward may increase. By assessing such choices across multiple delays, delay discounting quantifies the devaluation of rewards over time, which allows for an index of overall discounting rate (k). Delay Discounting of money rate has no units and values can go from 0-infinity. A larger discount rate indicates that a future reward is devalued more, and is associated with more impulsive behavior.
次要结局
- Study Session Peak Pain Visual Analog Scale (VAS)(Peak Pain VAS will be the highest rating during each 2 hour study session.)
- Peak Clinical Opiate Withdrawal Scale (COWS) Rating(Peak COWS rating will be the highest rating during each 2 hour study session.)
- Peak Subjective Opiate Withdrawal Scale (SOWS) Rating(Peak SOWS rating will be the highest rating during each 2 hour study session.)
- Peak Increase From Baseline Pupil Diameter(Peak increase from baseline pupil diameter will be the largest increase from baseline pupil diameter measured during each 2 hour study session.)