Pilot Study of Opioid-receptor Antagonists to Reduce Pain and Inflammation Among HIV-Infected Persons With Alcohol Problems
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Medication Tolerability Measured Via a 0-100 Visual Analog Scale
研究概览
简要总结
This study is a randomized controlled trial (RCT) to assess the feasibility, tolerability, and safety of using opioid receptor antagonists (naltrexone and nalmefene) to treat pain among HIV-infected persons with heavy alcohol use and chronic pain.
详细描述
Pain is a common co-morbidity for HIV-infected patients. Prevalence studies suggest that, on average, half of all HIV-infected persons suffer pain. Chronic pain can lead to heavy alcohol use among HIV-infected 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. Opioid receptor antagonists such as naltrexone and nalmefene, which are licensed for treatment of alcohol use disorders, show promise as being effective and safe treatments for chronic pain among persons with HIV. This study will pilot test novel pharmacotherapies (opioid receptor antagonists) to improve chronic pain among HIV-infected heavy drinkers. The specific aims of the research is to assess the feasibility, tolerability and safety of using opioid receptor antagonists (low-dose naltrexone and nalmefene) to treat pain among HIV-infected persons with heavy alcohol use and chronic pain.
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
- •Uncontrolled psychiatric illness (such as active psychosis) (i.e., answered yes to any of the following: past three month active hallucinations; mental health symptoms prompting a visit to the ED or hospital)
- •History of hypersensitivity to naltrexone, nalmefene, 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
- •ALT/AST levels >5x normal
- •History of Raynaud's Disease
- •Planned surgeries in the next three months
- •Enrolled in another HIV and/or substance use medication intervention study
- •Taking naltrexone in the past 30 days
- •Taking nalmefene in the past 30 days
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)
Nalmefene
Participants randomized to this group will receive nalmefene (18 mg) for 8 weeks.
干预措施: Nalmefene (Drug)
结局指标
主要结局
Medication Tolerability Measured Via a 0-100 Visual Analog Scale
时间窗: Primary endpoint at 8 weeks
Medication tolerability will be measured via a 0-100 visual analog scale. Participants will be asked to indicate on a scale of 0-100, how well they have tolerated the study medication with 0 anchored as "cannot tolerate at all" and 100 as "tolerate perfectly well." Higher numbers will be indicative of higher tolerability of the medication.
次要结局
- Adherence to Medication Defined as Self-report of Percentage of Study Medication Taken in the Past Two Weeks(Endpoint at 8 weeks)
- Number of Participants With Adherence Assessed Via Riboflavin in the Urine Confirming Adherence(Endpoint at 8 weeks)
- Reported Side Effects Using a Symptom Checklist, Plus an Open-ended Question(2 weeks, 4 weeks, 6 weeks, 8 weeks)
- Severe Hepatotoxicity Defined as AST/ALT >10X the Level of Normal(Endpoint at 8 weeks)
- Treatment Discontinuation Defined as Patient Self-report of Stopping Medication Anytime During the Treatment Period(4 weeks, 8 weeks)
- Medication Satisfaction Defined as a Score From 0-100 Measured Via the Treatment Satisfaction Questionnaire for Medication (TSQM), With Higher Scores Corresponding to Higher Treatment Satisfaction.(4 weeks, 8 weeks)
- Change in Alcohol Use Defined as a Change in the Mean Number of Grams of Pure Ethanol Consumed Per Day From Baseline to 8 Weeks(Baseline, 8 weeks)