St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Nalmefene

Phase 1

Completed

Conditions: HIV Infection
Alcohol Use
Pain

Interventions: Drug: Low dose naltrexone
Drug: Nalmefene

Registration Number: NCT03278886

Lead Sponsor: Boston Medical Center

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 11

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose naltrexone	Low dose naltrexone	Participants randomized to this group will receive low dose naltrexone (4.5 mg) for 8 weeks.
Nalmefene	Nalmefene	Participants randomized to this group will receive nalmefene (18 mg) for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Medication Tolerability Measured Via a 0-100 Visual Analog Scale	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.

Secondary Outcome Measures

Name	Time	Method
Adherence to Medication Defined as Self-report of Percentage of Study Medication Taken in the Past Two Weeks	Endpoint at 8 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.
Number of Participants With Adherence Assessed Via Riboflavin in the Urine Confirming Adherence	Endpoint at 8 weeks	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.
Reported Side Effects Using a Symptom Checklist, Plus an Open-ended Question	2 weeks, 4 weeks, 6 weeks, 8 weeks	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.
Severe Hepatotoxicity Defined as AST/ALT >10X the Level of Normal	Endpoint at 8 weeks	Aminotransferase levels (AST/ALT) are tested to look for severe hepatotoxicity defined as AST/ALT \> 10 times the level of normal.
Treatment Discontinuation Defined as Patient Self-report of Stopping Medication Anytime During the Treatment Period	4 weeks, 8 weeks	Measured via one question asking participants if they had discontinued medication since their last visit. Assessed at 4 and 8 week study visits.
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	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.
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	Measured via 30 Day Alcohol Use Timeline Follow Back Method