Phase 2
Completed N=45
St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Gabapentin
Postoperative Pain · Alcohol Use, Unspecified · HIV
Source: ClinicalTrials.gov NCT04052139 ↗
Enrolled (actual)
45
Serious AEs
4.4%
Results posted
Nov 2022
Primary outcomePrimary: Change in Past Week Pain Severity — -0.97; -2.12; -1.85 units on a scale
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Past Week Pain Severity |
-0.97; -2.12; -1.85 | — |
| PRIMARY Change in Past Week Pain Interference |
-1.73; -1.97; -2.14 | — |
| SECONDARY Change in Cold Pain Tolerance |
-14.78; -3.33; -3.15 | — |
| SECONDARY Change in Percentage of Past Month Heavy Drinking Days |
3.07; -4.22; -4.63 | — |
| SECONDARY Change in CD4 Count |
15.85; -106.47; -52.13 | — |
| SECONDARY Number of Participants With a Change in HIV Viral Load Suppression Status |
1; 0; 0 | — |
| SECONDARY Change in Biomarker IL-6 |
-0.12; 0.04; 0.29 | — |
| SECONDARY Change in Biomarker IL-10 |
-0.13; 0.07; -0.26 | — |
| SECONDARY Change in TNF-alpha |
0.27; 0.47; 0.21 | — |
| SECONDARY Change in IL-1beta |
0.30; 0.95; 0.41 | — |
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)
Data sourced from ClinicalTrials.gov (NCT04052139). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.