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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04052139
Recruitment Status : Not yet recruiting
First Posted : August 9, 2019
Last Update Posted : November 25, 2020
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Boston Medical Center

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).

Condition or disease Intervention/treatment Phase
Chronic Pain Alcohol Use, Unspecified HIV Infections Drug: Low-dose naltrexone Drug: Gabapentin Drug: Placebo Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study of Opioid-receptor Antagonists to Reduce Pain and Inflammation Among HIV-Infected Persons With Alcohol Problems
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Low-dose naltrexone
Participants randomized to this group will receive low dose naltrexone (4.5 mg) for 8 weeks.
Drug: Low-dose naltrexone
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.

Active Comparator: Gabapentin
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
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).

Placebo Comparator: Placebo
Participants will receive a placebo to be taken three times daily for 8 weeks.
Drug: Placebo
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 Measures :
  1. Change in past week pain severity [ Time Frame: Endpoint at 8-weeks ]
    Change in past week pain severity (score 0-10) from baseline to week 8. Pain severity will be measured using the Brief Pain Inventory

  2. Change in past week pain interference [ Time Frame: Endpoint at 8-weeks ]
    Change in past week pain interference (score 0-10) from baseline to week 8. Pain interference will be measured using the Brief Pain Inventory


Secondary Outcome Measures :
  1. Change in Biomarkers IL-6, IL-β, IL-10, and TNF-α between baseline and week 8 [ Time Frame: Endpoint at 8-weeks ]
    Levels of these pro-inflammatory markers will be measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R&D Systems).

  2. Change in cold pain tolerance between baseline and week 8 [ Time Frame: Endpoint at 8-weeks ]
    This will be measured using the cold-pressor test; briefly it is the number of seconds a participant can keep hand submerged in cold water bath

  3. Change in percentage of past month heavy drinking days between baseline and week 8 [ Time Frame: Endpoint at 8-weeks ]
    Timeline Follow Back method will be used to assess drinks per day in the past 4 weeks. Using a calendar, participants provide retrospective estimates of their daily drinking over the past 30 days from the interview date.

  4. Change in measures of HIV control between baseline and week 8 [ Time Frame: Endpoint at 8-weeks ]
    CD4 cell counts and HIV viral loads will be measured on participants



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Diagnosis of chronic obstructive pulmonary disease (COPD)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04052139


Contacts
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Contact: Jeffrey H. Samet, MD, MA, MPH 617-414-7288 jsamet@bu.edu
Contact: Judith I. Tsui, MD, MPH 206-744-1835 tsuij@uw.edu

Locations
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Russian Federation
First St. Petersburg Pavlov State Medical University
Saint Petersburg, Russian Federation
Contact: Evgeny Krupitsky, MD,PhD,DMdSc    +7-812-365-2217    kruenator@gmail.com   
Sponsors and Collaborators
Boston Medical Center
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Jeffrey H. Samet, MD, MA, MPH Boston University/Boston Medical Center
Additional Information:
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Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT04052139    
Other Study ID Numbers: H-39162
UH3AA026193 ( U.S. NIH Grant/Contract )
First Posted: August 9, 2019    Key Record Dates
Last Update Posted: November 25, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All data from the study will be placed into the URBAN ARCH repository.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boston Medical Center:
Pain
Alcohol
HIV
Inflammation
Low-dose naltrexone
Gabapentin
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Naltrexone
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Alcohol Deterrents
Narcotic Antagonists