{"doi":"10.1371/journal.pone.0297948","title":"Pilot RCT comparing low-dose naltrexone, gabapentin and placebo to reduce pain among people with HIV with alcohol problems","abstract":"BACKGROUND: To estimate the effects on pain of two medications (low-dose naltrexone and gabapentin) compared to placebo among people with HIV (PWH) with heavy alcohol use and chronic pain. METHODS: We conducted a pilot, randomized, double-blinded, 3-arm study of PWH with chronic pain and past-year heavy alcohol use in 2021. Participants were recruited in St. Petersburg, Russia, and randomized to receive daily low-dose naltrexone (4.5mg), gabapentin (up to 1800mg), or placebo. The two primary outcomes were change in self-reported pain severity and pain interference measured with the Brief Pain Inventory from baseline to 8 weeks. RESULTS: Participants (N = 45, 15 in each arm) had the following baseline characteristics: 64% male; age 41 years (SD±7); mean 2 (SD±4) heavy drinking days in the past month and mean pain severity and interference were 3.2 (SD±1) and 3.0 (SD±2), respectively. Pain severity decreased for all three arms. Mean differences in change in pain severity for gabapentin vs. placebo, and naltrexone vs. placebo were -0.27 (95% confidence interval [CI] -1.76, 1.23; p = 0.73) and 0.88 (95% CI -0.7, 2.46; p = 0.55), respectively. Pain interference decreased for all three arms. Mean differences in change in pain interference for gabapentin vs. placebo, and naltrexone vs. placebo was 0.16 (95% CI -1.38, 1.71; p = 0.83) and 0.40 (95% CI -1.18, 1.99; p = 0.83), respectively. CONCLUSION: Neither gabapentin nor low-dose naltrexone appeared to improve pain more than placebo among PWH with chronic pain and past-year heavy alcohol use. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov (NCT4052139).","journal":"PLoS ONE","year":2024,"id":475457,"datarank":0.25195341783535063,"base_score":1.3862943611198906,"endowment":1.3862943611198906,"self_citation_contribution":0.20794415416798362,"citation_network_contribution":0.044009263667367,"self_endowment_contribution":0.20794415416798362,"citer_contribution":0.044009263667367,"corpus_percentile":null,"corpus_rank":null,"citation_count":3,"citer_count":3,"citers_with_citation_signal":2,"citers_with_endowment":2,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.757,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT04052139"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2024-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":768887,"name":"Sarah L. Rossi","orcid":"0000-0002-4168-5267","position":1,"is_corresponding":false},{"id":446874,"name":"Debbie M. Cheng","orcid":"0000-0002-2206-3059","position":2,"is_corresponding":false},{"id":446876,"name":"Sally Bendiks","orcid":"0000-0002-0769-6106","position":3,"is_corresponding":false},{"id":768890,"name":"Marina Vetrova","orcid":"0000-0002-9698-0327","position":4,"is_corresponding":false},{"id":446873,"name":"Elena Blokhina","orcid":"0000-0001-5811-9897","position":5,"is_corresponding":false},{"id":518275,"name":"Michael Winter","orcid":null,"position":6,"is_corresponding":false},{"id":446871,"name":"Natalia Gnatienko","orcid":"0000-0002-0019-762X","position":7,"is_corresponding":false},{"id":407439,"name":"Miroslav Bačkonja","orcid":"0000-0001-5098-478X","position":8,"is_corresponding":false},{"id":467581,"name":"Kendall Bryant","orcid":"0000-0002-0792-1449","position":9,"is_corresponding":false},{"id":268075,"name":"Evgeny Krupitsky","orcid":"0000-0002-0529-4525","position":10,"is_corresponding":false},{"id":315654,"name":"Jeffrey H. Samet","orcid":"0000-0002-0897-3400","position":11,"is_corresponding":false},{"id":403893,"name":"Judith I. Tsui","orcid":"0000-0003-0877-5399","position":0,"is_corresponding":true}],"reference_count":78,"raw_metadata":null,"created_at":"2026-07-19T02:06:21.071690Z","pmid":"38408060","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}