Clinical trial NCT03278886: St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Nalmefene
Official title: Pilot Study of Opioid-receptor Antagonists to Reduce Pain and Inflammation Among HIV-Infected Persons With Alcohol Problems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: HIV Infection
Alcohol Use
Pain
Keywords: Alcohol Use
Pain
HIV
Low-dose naltrexone
Nalmefene
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2017-09-12
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Medication Tolerability Measured Via a 0-100 Visual Analog Scale
timeFrame: Primary endpoint at 8 weeks
Secondary outcomes:
measure: 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
timeFrame: Baseline, 8 weeks
measure: Treatment Discontinuation Defined as Patient Self-report of Stopping Medication Anytime During the Treatment Period
timeFrame: 4 weeks, 8 weeks
measure: Adherence to Medication Defined as Self-report of Percentage of Study Medication Taken in the Past Two Weeks
timeFrame: Endpoint at 8 weeks
measure: Number of Participants With Adherence Assessed Via Riboflavin in the Urine Confirming Adherence
timeFrame: Endpoint at 8 weeks
measure: Reported Side Effects Using a Symptom Checklist, Plus an Open-ended Question
timeFrame: 2 weeks, 4 weeks, 6 weeks, 8 weeks
measure: 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.
timeFrame: 4 weeks, 8 weeks
measure: Severe Hepatotoxicity Defined as AST/ALT >10X the Level of Normal
timeFrame: Endpoint at 8 weeks
Other outcomes:
Locations:
city: St. Petersburg
country: Russian Federation
facility: First St. Petersburg Pavlov State Medical University
Study officials:
affiliation: Boston University/Boston Medical Center
name: Jeffrey H. Samet, MD, MA, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bendiks S, Cheng DM, Blokhina E, Vetrova M, Verbitskaya E, Gnatienko N, Bryant K, Krupitsky E, Samet JH, Tsui JI. Pilot study of tolerability and safety of opioid receptor antagonists as novel therapies for chronic pain among persons living with HIV with past year heavy drinking: a randomized controlled trial. AIDS Care. 2023 Aug;35(8):1191-1200. doi: 10.1080/09540121.2021.1896663. Epub 2021 Mar 7.