St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Gabapentin

NCT04052139 | Completed Phase 2 Results DMC

• 2 other identifiers: H-39162UH3AA026193
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a 3-arm pilot, randomized, double-blinded, placebo-controlled study of low-dose naltrexone and gabapentin versus placebo among HIV-positive persons with heavy alcohol use and chronic pain to provide estimates of their effects on 1) pain; 2) inflammation; and 3) measures of HIV control. Participants will be followed for 12 weeks. Assessments of study outcomes will be compared at week 8 (end of treatment phase).

Conditions

Chronic Pain; Alcohol Use, Unspecified; HIV Infections

Keywords

Pain; Alcohol; HIV; Inflammation; Low-dose naltrexone; Gabapentin

Outcome Measures

Primary Outcomes (2)

• Change in Past Week Pain Severity

  Change in past week pain severity (score 0 \[no pain\] -10 \[high pain\]) from baseline to week 8. Pain severity will be measured using the Brief Pain Inventory, which allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function

  Baseline, 8-weeks

• Change in Past Week Pain Interference

  Change in past week pain interference (score 0 \[no pain\]-10 \[high pain\]) from baseline to week 8. Pain interference will be measured using the Brief Pain Inventory, which allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function

  Baseline, 8-weeks

Secondary Outcomes (8)

• Change in Cold Pain Tolerance

  Baseline, 8-weeks

• Change in Percentage of Past Month Heavy Drinking Days

  Baseline, 8-weeks

• Change in CD4 Count

  Baseline, 8-weeks

• Number of Participants With a Change in HIV Viral Load Suppression Status

  Baseline, 8-weeks

• Change in Biomarker IL-6

  Baseline, 8-weeks

Study Arms (3)

Low-dose naltrexone

ACTIVE COMPARATOR

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

Drug: Low-dose naltrexone

Gabapentin

ACTIVE COMPARATOR

Participants randomized to the gabapentin arm begin on a dose of 300 mg daily (300 mg qd). In week 2, participants will take 300 mg of gabapentin three times daily. In week 3 the dose will be titrated up to 1800 mg daily (300 mg+300 mg tid) will remain on the dose until week 8, when they will be tapered back down to 900 mg daily (300 mg tid). In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily).

Drug: Gabapentin

Placebo

PLACEBO COMPARATOR

Participants will receive a placebo to be taken three times daily for 8 weeks.

Drug: Placebo

Interventions

Low-dose naltrexone DRUG

4.5 mg of low dose naltrexone taken once daily for 8 weeks. In week 1, participants will take 4.5mg of naltrexone once daily. In week 2, participants will take 4.5mg of naltrexone once daily, and a placebo capsule twice daily. In weeks 3 through 7, participants will take 1 placebo capsule with 4.5 mg mg of naltrexone once daily, and 2 placebo capsules twice daily. In week 8, in days 1-4 participants will take 4.5 mg of naltrexone with a placebo capsule once daily and 2 placebo capsules twice daily; in days 5-7, participants will take 4.5 mg of naltrexone once daily, and a placebo capsule twice daily.

Low-dose naltrexone

Gabapentin DRUG

Dose will begin at 300 mg daily (300 mg qd), in week 2 the dose will be titrated up to 900 mg daily (300 mg tid). In week 3, the dose will be titrated to 1800 mg daily ( 2 capsules of 300 mg tid) and participants will remain on that dose until week 8. In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily).

Gabapentin

Placebo DRUG

In week 1, participants will take 1 placebo capsule once daily. In week 2, participants will take 1 placebo capsule three times per day. In weeks 3 through 7, 2 placebo capsules three times per day. In week 8, in days 1-4 participants will take 2 placebo capsules three times per day; in days 5-7, participants will take 1 placebo capsule three times per day. The placebo medications will be composed of lactose and will not contain active ingredients.

Placebo

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
• Known uncontrolled psychiatric illness (such as active psychosis)
• Current suicidal ideation
• History of hypersensitivity to naltrexone, gabapentin, 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
• AST/ALT levels \>5x normal
• CrCl\< 60mL/min
• History of Reynaud's disease

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, Russia

Location

Related Publications (1)

• Tsui JI, Rossi SL, Cheng DM, Bendiks S, Vetrova M, Blokhina E, Winter M, Gnatienko N, Backonja M, Bryant K, Krupitsky E, Samet JH. Pilot RCT comparing low-dose naltrexone, gabapentin and placebo to reduce pain among people with HIV with alcohol problems. PLoS One. 2024 Feb 26;19(2):e0297948. doi: 10.1371/journal.pone.0297948. eCollection 2024.

  PMID: 38408060 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

Chronic Pain; Alcohol Drinking; HIV Infections; Pain; Inflammation

Interventions

Naltrexone; Gabapentin

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Drinking Behavior; Behavior; 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; Pathologic Processes

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; Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

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

jsamet@bu.edu

617-414-7288

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 2
• 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: August 8, 2019
• First Posted: August 9, 2019
• Study Start: January 25, 2021
• Primary Completion: November 16, 2021
• Study Completion: December 15, 2021
• Last Updated: November 10, 2022
• Results First Posted: November 10, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share

Locations

RU (1)