Pilot Study of Opioid-receptor Antagonists to Reduce Pain and Inflammation Among HIV-Infected Persons With Alcohol Problems
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change in Past Week Pain Interference
研究概览
简要总结
This study is a 3-arm pilot, randomized, double-blinded, placebo-controlled study of low-dose naltrexone and gabapentin versus placebo among HIV-positive persons with heavy alcohol use and chronic pain to provide estimates of their effects on 1) pain; 2) inflammation; and 3) measures of HIV control. Participants will be followed for 12 weeks. Assessments of study outcomes will be compared at week 8 (end of treatment phase).
详细描述
Pain is a common co-morbidity for HIV-positive patients.Prevalence studies suggest that, on average, half of all HIV-positive persons suffer pain. Chronic pain can lead to heavy alcohol use among HIV-positive persons, which may in turn be a barrier to treatment/control of HIV and contribute to spread of HIV. Thus there is an urgent need to address pain among persons with HIV. It is timely and relevant to conduct research on gabapentin, as it has emerged as one of the most commonly prescribed non-opioid medications for pain despite the fact that gabapentin is only FDA approved for "post-herpetic neuralgia" and the literature to support its use for generalized chronic pain is limited. And yet, gabapentin has demonstrated benefits for treatment of alcohol use disorder, and therefore, like naltrexone, it could have a specific role for treating patients with chronic pain and unhealthy alcohol use. This study is a 3-arm pilot, randomized, double-blinded, placebo-controlled study of low-dose naltrexone and gabapentin vs. placebo among HIV-positive persons with heavy alcohol use and chronic pain to provide estimates of their effects on 1) pain (both self-reported and experimental/cold pressor test; 2) inflammation (i.e., levels of inflammatory cytokines IL-6, IL-1β, IL-10, and TNF-α); and 3) measures of HIV control (CD4 count and viral load).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •HIV-positive
- •Chronic pain (present ≥3 mo) of moderate to severe intensity
- •Heavy drinking past year (Based on NIAAA criteria: > 14 standard drinks per week/ > 4 drinks in a day for men; > 7 drinks in the past week/ > 3 drinks in a day for women)
- •If female, negative pregnancy test and willing to use adequate birth control
- •Provision of contact information for 2 contacts to assist with follow-up
- •Stable address within 100 kilometers of St. Petersburg
- •Possession of a telephone (home or cell)
- •Able and willing to comply with all study protocols and procedures
排除标准
- •Not fluent in Russian
- •Cognitive impairment resulting in inability to provide informed consent based on research assessor (RA) assessment
- •Known active TB or current febrile illness
- •Breastfeeding
- •Known uncontrolled psychiatric illness (such as active psychosis)
- •Current suicidal ideation
- •History of hypersensitivity to naltrexone, gabapentin, or naloxone
- •Current use (past week) of illicit or prescribed opiates as documented by either self-report or positive urine drug test
- •Unwilling to abstain from opiates during the treatment period
- •Current use of neuroleptics
- •History of seizure disorder
- •Known liver failure
- •AST/ALT levels >5x normal
- •CrCl< 60mL/min
- •History of Reynaud's disease
- •Planned surgeries in the next 3 months
- •Enrolled in another HIV and/or substance use medication intervention study
- •Taking naltrexone in the past 30 days
- •Taking gabapentin in the past 30 days
- •Taking pregabalin in the past 30 days
- •Diagnosis of chronic obstructive pulmonary disease (COPD)
研究组 & 干预措施
Low-dose naltrexone
Participants randomized to this group will receive low dose naltrexone (4.5 mg) for 8 weeks.
干预措施: Low-dose naltrexone (Drug)
Gabapentin
Participants randomized to the gabapentin arm begin on a dose of 300 mg daily (300 mg qd). In week 2, participants will take 300 mg of gabapentin three times daily. In week 3 the dose will be titrated up to 1800 mg daily (300 mg+300 mg tid) will remain on the dose until week 8, when they will be tapered back down to 900 mg daily (300 mg tid). In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily).
干预措施: Gabapentin (Drug)
Placebo
Participants will receive a placebo to be taken three times daily for 8 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Past Week Pain Interference
时间窗: Baseline, 8-weeks
Change in past week pain interference (score 0 \[no pain\]-10 \[high pain\]) from baseline to week 8. Pain interference will be measured using the Brief Pain Inventory, which allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function
Change in Past Week Pain Severity
时间窗: Baseline, 8-weeks
Change in past week pain severity (score 0 \[no pain\] -10 \[high pain\]) from baseline to week 8. Pain severity will be measured using the Brief Pain Inventory, which allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function
次要结局
- Change in Cold Pain Tolerance(Baseline, 8-weeks)
- Change in TNF-alpha(Baseline, 8-weeks)
- Change in IL-1beta(Baseline, 8-weeks)
- Change in Biomarker IL-10(Baseline, 8 weeks)
- Change in CD4 Count(Baseline, 8-weeks)
- Change in Percentage of Past Month Heavy Drinking Days(Baseline, 8-weeks)
- Number of Participants With a Change in HIV Viral Load Suppression Status(Baseline, 8-weeks)
- Change in Biomarker IL-6(Baseline, 8-weeks)