St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Gabapentin
Condition: Chronic Pain; Alcohol Use, Unspecified; HIV Infections
MeSH terms: Chronic Pain
Intervention: Low-dose naltrexone; Gabapentin; Placebo
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.; 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).; 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.
Intervention MeSH terms: Naltrexone; Gabapentin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pain; Alcohol; HIV; Inflammation; Low-dose naltrexone; Gabapentin

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).
    

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)