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St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Gabapentin (UH3)

Primary Purpose

Chronic Pain, Alcohol Use, Unspecified, HIV Infections

Status
Completed
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Low-dose naltrexone
Gabapentin
Placebo
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Pain, Alcohol, HIV, Inflammation, Low-dose naltrexone, Gabapentin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
  • 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
  • Planned surgeries in the next 3 months
  • Enrolled in another HIV and/or substance use medication intervention study
  • Taking naltrexone in the past 30 days
  • Taking gabapentin in the past 30 days
  • Taking pregabalin in the past 30 days
  • Diagnosis of chronic obstructive pulmonary disease (COPD)

Sites / Locations

  • First St. Petersburg Pavlov State Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Low-dose naltrexone

Gabapentin

Placebo

Arm Description

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

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).

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Change in Cold Pain Tolerance
Mean change in the number of seconds a participant can keep their hand submerged in a container of iced water. Participants were instructed to keep their hand in as long as they could, up to 3 minutes.
Change in Percentage of Past Month Heavy Drinking Days
Mean percentage of change in self-reported heavy drinking in the past 30 days of alcohol consumption obtained via the Timeline Followback (TLFB) method. The NIAAA definition of heavy drinking is used (> 4 drinks in a day for men; > 3 drinks in a day for women). Participants were asked about their alcohol consumption on each day in the previous 30 days.
Change in CD4 Count
Defined as mean change in CD4 values from lab assay
Number of Participants With a Change in HIV Viral Load Suppression Status
Defined as number of participants who change from suppressed to unsuppressed or unsuppressed to suppressed from lab tests
Change in Biomarker IL-6
Mean change in IL-6 values measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R&D Systems).
Change in Biomarker IL-10
Mean change in IL-10 values measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R&D Systems).
Change in TNF-alpha
Mean change in TNF-alpha values measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R&D Systems).
Change in IL-1beta
Mean change in IL-1beta values measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R&D Systems).

Full Information

First Posted
August 8, 2019
Last Updated
October 14, 2022
Sponsor
Boston Medical Center
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT04052139
Brief Title
St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Gabapentin
Acronym
UH3
Official Title
Pilot Study of Opioid-receptor Antagonists to Reduce Pain and Inflammation Among HIV-Infected Persons With Alcohol Problems
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 25, 2021 (Actual)
Primary Completion Date
November 16, 2021 (Actual)
Study Completion Date
December 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Medical Center
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).
Detailed Description
Pain is a common co-morbidity for HIV-positive patients.Prevalence studies suggest that, on average, half of all HIV-positive persons suffer pain. Chronic pain can lead to heavy alcohol use among HIV-positive 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. It is timely and relevant to conduct research on gabapentin, as it has emerged as one of the most commonly prescribed non-opioid medications for pain despite the fact that gabapentin is only FDA approved for "post-herpetic neuralgia" and the literature to support its use for generalized chronic pain is limited. And yet, gabapentin has demonstrated benefits for treatment of alcohol use disorder, and therefore, like naltrexone, it could have a specific role for treating patients with chronic pain and unhealthy alcohol use. This study is a 3-arm pilot, randomized, double-blinded, placebo-controlled study of low-dose naltrexone and gabapentin vs. placebo among HIV-positive persons with heavy alcohol use and chronic pain to provide estimates of their effects on 1) pain (both self-reported and experimental/cold pressor test; 2) inflammation (i.e., levels of inflammatory cytokines IL-6, IL-1β, IL-10, and TNF-α); and 3) measures of HIV control (CD4 count and viral load).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Alcohol Use, Unspecified, HIV Infections
Keywords
Pain, Alcohol, HIV, Inflammation, Low-dose naltrexone, Gabapentin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-dose naltrexone
Arm Type
Active Comparator
Arm Description
Participants randomized to this group will receive low dose naltrexone (4.5 mg) for 8 weeks.
Arm Title
Gabapentin
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive a placebo to be taken three times daily for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Low-dose naltrexone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Past Week Pain Severity
Description
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
Time Frame
Baseline, 8-weeks
Title
Change in Past Week Pain Interference
Description
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
Time Frame
Baseline, 8-weeks
Secondary Outcome Measure Information:
Title
Change in Cold Pain Tolerance
Description
Mean change in the number of seconds a participant can keep their hand submerged in a container of iced water. Participants were instructed to keep their hand in as long as they could, up to 3 minutes.
Time Frame
Baseline, 8-weeks
Title
Change in Percentage of Past Month Heavy Drinking Days
Description
Mean percentage of change in self-reported heavy drinking in the past 30 days of alcohol consumption obtained via the Timeline Followback (TLFB) method. The NIAAA definition of heavy drinking is used (> 4 drinks in a day for men; > 3 drinks in a day for women). Participants were asked about their alcohol consumption on each day in the previous 30 days.
Time Frame
Baseline, 8-weeks
Title
Change in CD4 Count
Description
Defined as mean change in CD4 values from lab assay
Time Frame
Baseline, 8-weeks
Title
Number of Participants With a Change in HIV Viral Load Suppression Status
Description
Defined as number of participants who change from suppressed to unsuppressed or unsuppressed to suppressed from lab tests
Time Frame
Baseline, 8-weeks
Title
Change in Biomarker IL-6
Description
Mean change in IL-6 values measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R&D Systems).
Time Frame
Baseline, 8-weeks
Title
Change in Biomarker IL-10
Description
Mean change in IL-10 values measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R&D Systems).
Time Frame
Baseline, 8 weeks
Title
Change in TNF-alpha
Description
Mean change in TNF-alpha values measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R&D Systems).
Time Frame
Baseline, 8-weeks
Title
Change in IL-1beta
Description
Mean change in IL-1beta values measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R&D Systems).
Time Frame
Baseline, 8-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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 Planned surgeries in the next 3 months Enrolled in another HIV and/or substance use medication intervention study Taking naltrexone in the past 30 days Taking gabapentin in the past 30 days Taking pregabalin in the past 30 days Diagnosis of chronic obstructive pulmonary disease (COPD)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey H. Samet, MD, MA, MPH
Organizational Affiliation
Boston University/Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
First St. Petersburg Pavlov State Medical University
City
Saint Petersburg
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All data from the study will be placed into the URBAN ARCH repository.
Links:
URL
http://www.urbanarch.org
Description
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.

Learn more about this trial

St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Gabapentin

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