- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04052139
St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Gabapentin (UH3)
October 14, 2022 updated by: Boston Medical Center
Pilot Study of Opioid-receptor Antagonists to Reduce Pain and Inflammation Among HIV-Infected Persons With Alcohol Problems
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Saint Petersburg, Russian Federation
- First St. Petersburg Pavlov State Medical University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Low-dose naltrexone
Participants randomized to this group will receive low dose naltrexone (4.5 mg) for 8 weeks.
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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.
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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).
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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).
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Placebo Comparator: Placebo
Participants will receive a placebo to be taken three times daily for 8 weeks.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Past Week Pain Severity
Time Frame: Baseline, 8-weeks
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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
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Baseline, 8-weeks
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Change in Past Week Pain Interference
Time Frame: Baseline, 8-weeks
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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
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Baseline, 8-weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Cold Pain Tolerance
Time Frame: Baseline, 8-weeks
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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.
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Baseline, 8-weeks
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Change in Percentage of Past Month Heavy Drinking Days
Time Frame: Baseline, 8-weeks
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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.
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Baseline, 8-weeks
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Change in CD4 Count
Time Frame: Baseline, 8-weeks
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Defined as mean change in CD4 values from lab assay
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Baseline, 8-weeks
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Number of Participants With a Change in HIV Viral Load Suppression Status
Time Frame: Baseline, 8-weeks
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Defined as number of participants who change from suppressed to unsuppressed or unsuppressed to suppressed from lab tests
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Baseline, 8-weeks
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Change in Biomarker IL-6
Time Frame: Baseline, 8-weeks
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Mean change in IL-6 values measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R&D Systems).
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Baseline, 8-weeks
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Change in Biomarker IL-10
Time Frame: Baseline, 8 weeks
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Mean change in IL-10 values measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R&D Systems).
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Baseline, 8 weeks
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Change in TNF-alpha
Time Frame: Baseline, 8-weeks
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Mean change in TNF-alpha values measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R&D Systems).
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Baseline, 8-weeks
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Change in IL-1beta
Time Frame: Baseline, 8-weeks
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Mean change in IL-1beta values measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R&D Systems).
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Baseline, 8-weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jeffrey H. Samet, MD, MA, MPH, Boston University/Boston Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 25, 2021
Primary Completion (Actual)
November 16, 2021
Study Completion (Actual)
December 15, 2021
Study Registration Dates
First Submitted
August 8, 2019
First Submitted That Met QC Criteria
August 8, 2019
First Posted (Actual)
August 9, 2019
Study Record Updates
Last Update Posted (Actual)
November 10, 2022
Last Update Submitted That Met QC Criteria
October 14, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Chronic Pain
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Anti-Anxiety Agents
- Narcotic Antagonists
- Anticonvulsants
- Antimanic Agents
- Alcohol Deterrents
- Gabapentin
- Naltrexone
Other Study ID Numbers
- H-39162
- UH3AA026193 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
All data from the study will be placed into the URBAN ARCH repository.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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