St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Nalmefene

NCT03278886 | Completed Phase 1 Results DMC

• 2 other identifiers: H-36491UH2AA026193
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infection; Alcohol Use; Pain

Keywords

Alcohol Use; Pain; HIV; Low-dose naltrexone; Nalmefene

Outcome Measures

Primary Outcomes (1)

• 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.

  Primary endpoint at 8 weeks

Secondary Outcomes (7)

• 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

• Treatment Discontinuation Defined as Patient Self-report of Stopping Medication Anytime During the Treatment Period

  4 weeks, 8 weeks

• 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

Study Arms (2)

Low dose naltrexone

EXPERIMENTAL

Participants randomized to this group will receive low dose naltrexone (4.5 mg) for 8 weeks.

Drug: Low dose naltrexone

Nalmefene

EXPERIMENTAL

Participants randomized to this group will receive nalmefene (18 mg) for 8 weeks.

Drug: Nalmefene

Interventions

Low dose naltrexone DRUG

4.5 mg of low dose naltrexone taken once daily for 8 weeks

Low dose naltrexone

Nalmefene DRUG

18 mg of nalmefene taken once daily for 8 weeks

Nalmefene

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Center: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

First St. Petersburg Pavlov State Medical University

Saint Petersburg, 197022, Russia

Location

Related Publications (1)

• 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.

  PMID: 33682527 DERIVED

Related Links

• URBAN ARCH, a member of NIAAA CHAART (Consortiums for HIV/AIDS \& Alcohol Research Translation) initiative, conducts and disseminates interdisciplinary research on how alcohol impacts people with HIV and develops interventions to reduce related outcomes.

MeSH Terms

Conditions

HIV Infections; Alcohol Drinking; Pain

Interventions

Naltrexone; nalmefene

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Drinking Behavior; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Jeffrey Samet
• Organization: Boston Medical Center

jsamet@bu.edu

617-414-7444

Study Officials

• Jeffrey H. Samet, MD, MA, MPH

  Boston University/Boston Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: September 12, 2017
• Study Start: July 3, 2018
• Primary Completion: December 19, 2018
• Study Completion: December 19, 2018
• Last Updated: August 24, 2020
• Results First Posted: August 3, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share

Locations

RU (1)