Mechanistic Evaluation of Gabapentin and Opioid Polypharmacy
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Peak change from baseline Drug Effect
研究概览
简要总结
This is a single-group, within-subject, double-blind, double-dummy, placebo-controlled study evaluating whether gabapentin (Neurontin) changes the analgesic, safety, and subjective effects of the opioid hydromorphone (Dilaudid) when the two are combined.
详细描述
This is a human laboratory systematic examination of whether adding the FDA-approved gabapentin (Neurontin; oral) to the FDA-approved opioid hydromorphone (Dilaudid; oral) will change the experience of hydromorphone as rated by laboratory measures of pain, subjective reports of drug effects, and cognitive performance. Subjects are healthy individuals with chronic lower back pain and no history of substance use disorder. Study subjects and staff are blinded to the study drugs and the class of drugs under investigation and are informed that subjects may receive opioids, stimulants, gabapentinoids, cannabinoids, benzodiazepines, over the counter medications, and/or placebo. Sessions last up to 8-hours in an outpatient setting. Primary outcomes are collected from participants prior to dosing and at several hour periods post-dosing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Drug class is blinded to participant.
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
- •18-65 years old
- •Lifetime history of opioid use
- •Medically cleared to take study medications
- •Chronic Lower Back Pain
- •Agree to use effective form of contraception throughout enrollment
排除标准
- •Pregnant or breastfeeding
- •Have evidence of physical dependence on or current use of any central nervous system depressants including but not limited to alcohol, benzodiazepines, opioids, gabapentinoids, or barbiturates
- •Past 30-day use of certain pain medications
- •Evidence of past 7-day nonmedical drug use
- •Known hypersensitvity, allergy to, or history of adverse reactions to study medications
- •Are currently taking a medication or have a condition that is contraindicated with either study medication
- •Have evidence of current or past significant medical/psychiatric illness
- •Have a history of clinically significant cardiac arrhythmias or vasospastic disease
- •Have evidence of renal or hepatic impairment
- •Current suicidal ideation or behavior, or a history of a suicide attempt within the past 2 years
- •Have any condition that may increases the risk for respiratory depression
研究组 & 干预措施
Active hydromorphone, Low dose gabapentin
4mg oral hydromorphone, 300mg oral gabapentin
干预措施: Within-subject test of blinded study medications (Placebo, Hydromorphone, Gabapentin) (Drug)
Placebo hydromorphone, Placebo gabapentin
0mg oral hydromorphone, 0mg oral gabapentin
干预措施: Within-subject test of blinded study medications (Placebo, Hydromorphone, Gabapentin) (Drug)
Active hydromorphone, High dose gabapentin
4mg oral hydromorphone, 900mg oral gabapentin
干预措施: Within-subject test of blinded study medications (Placebo, Hydromorphone, Gabapentin) (Drug)
Placebo hydromorphone, Low dose gabapentin
0mg oral hydromorphone, 300mg oral gabapentin
干预措施: Within-subject test of blinded study medications (Placebo, Hydromorphone, Gabapentin) (Drug)
Placebo hydromorphone, High dose gabapentin
0mg oral hydromorphone, 900mg oral gabapentin
干预措施: Within-subject test of blinded study medications (Placebo, Hydromorphone, Gabapentin) (Drug)
Active hydromorphone, placebo gabapentin
4mg oral hydromorphone, 0mg gabapentin
干预措施: Within-subject test of blinded study medications (Placebo, Hydromorphone, Gabapentin) (Drug)
结局指标
主要结局
Peak change from baseline Drug Effect
时间窗: 8 hour study sessions
Peak self-reported "Drug Effect" on a visual analogue scale (0-100) minus baseline ratings of self-reported "Drug Effect" on a visual anaogue scale (0-100)
Peak change from baseline Good Effect
时间窗: Baseline (0.5 hours before drug administration) and 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, and 8 hours after drug administration
Peak self-reported "Good Effect" on a visual analogue scale (0-100) minus baseline ratings of self-reported "Good Effect" on a visual anaogue scale (0-100), where lower scores indicate no effect and greater scores indicate maximum effect.
Peak Cold Pressor Test Tolerance change from baseline score
时间窗: Baseline (0.5 hours before drug administration) and 4 and 6 hours after study drug administration
Peak Cold Pressor Test Tolerance Score minus baseline Peak Cold Pressor Test Tolerance score. Outcome ranges from 0-60 seconds, 0 indicating low analgesic effect and 60 indicating high analgesic effects.
Peak Cold Pressor Test Threshold change from baseline score
时间窗: Baseline (0.5 hours before drug administration) and 4 and 6 hours after study drug administration
Peak Cold Pressor Test Threshold Score minus baseline Peak Cold Pressor Test Threshold score. Outcome ranges from 0-60 seconds, 0 indicating low analgesic effect and 60 indicating high analgesic effects.
Peak Heat Pain with Capsaicin Threshold change from baseline score
时间窗: Baseline (0.5 hours before drug administration) and 4 and 6 hours after study drug administration
Peak Heat Pain with Capsaicin Threshold score minus baseline Peak Heat Pain with Capsaicin Threshold score. Outcome ranges from 0-100, 0 indicating no pain and 100 indicating extreme pain.
Peak Heat Pain with Capsaicin Tolerance Change from Baseline Score
时间窗: Baseline (0.5 hours before drug administration) and 4 and 6 hours after study drug administration
Peak Heat Pain with Capsaicin Tolerance score minus baseline Peak Heat Pain with Capsaicin Tolerance score. Outcome ranges from 0-100, 0 indicating no pain and 100 indicating extreme pain.
Peak change from baseline Bad Effect
时间窗: Baseline (0.5 hours before drug administration) and 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, and 8 hours after drug administration
Peak self-reported "Bad Effect" on a visual analogue scale (0-100) minus baseline ratings of self-reported "Bad Effect" on a visual anaogue scale (0-100) where lower scores indicate no effect and greater scores indicate maximum effect.
次要结局
未报告次要终点
研究者
Cecilia Bergeria
Associate Professor
University of Maryland, Baltimore