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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
11
4.5 mg of low dose naltrexone taken once daily for 8 weeks
18 mg of nalmefene taken once daily for 8 weeks
First St. Petersburg Pavlov State Medical University
Saint Petersburg, Russia
Medication Tolerability Measured Via a 0-100 Visual Analog Scale
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.
Time frame: Primary endpoint at 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
Measured via 30 Day Alcohol Use Timeline Follow Back Method
Time frame: Baseline, 8 weeks
Treatment Discontinuation Defined as Patient Self-report of Stopping Medication Anytime During the Treatment Period
Measured via one question asking participants if they had discontinued medication since their last visit. Assessed at 4 and 8 week study visits.
Time frame: 4 weeks, 8 weeks
Adherence to Medication Defined as Self-report of Percentage of Study Medication Taken in the Past Two Weeks
Measured by participants' drawing a line on a a Visual Analog Scale, which ranges from 0 to 100. Higher numbers indicate higher adherence to study medication.
Time frame: Endpoint at 8 weeks
Number of Participants With Adherence Assessed Via Riboflavin in the Urine Confirming Adherence
Measured through visual inspection of the urine for the presence or absence of riboflavin using ultraviolet (UV) light at the long wave setting (33 mm) in a room with low ambient light.
Time frame: Endpoint at 8 weeks
Reported Side Effects Using a Symptom Checklist, Plus an Open-ended Question
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Measured via a 16-item symptom checklist with the option for participants to report any experienced side effects not on the checklist. Side effect severity is rated by trained research assessors. The checklist is asked at 2, 4, 6, and 8-week study visits.
Time frame: 2 weeks, 4 weeks, 6 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.
Measured via using the 14-item Treatment Satisfaction Questionnaire, which consists of 14 items that result in four domains: Effectiveness, Side Effects, Convenience and Global Satisfaction. Higher scores indicate greater satisfaction with medication. Assessed at 4 and 8 week study visits.
Time frame: 4 weeks, 8 weeks
Severe Hepatotoxicity Defined as AST/ALT >10X the Level of Normal
Aminotransferase levels (AST/ALT) are tested to look for severe hepatotoxicity defined as AST/ALT \> 10 times the level of normal.
Time frame: Endpoint at 8 weeks