Ibudilast attenuates the association between pain intensity and heavy drinking in alcohol use disorder: A secondary analysis of a randomized clinical trial
Abstract
Background: Pain frequently co-occurs with alcohol use disorder (AUD) and may influence treatment response. In this secondary analysis of a completed randomized clinical trial, we examined whether baseline pain intensity and pain-related disability moderate the effects of ibudilast, a neuroimmune-modulating agent, on drinking outcomes over 12 weeks. Method: Participants (N = 102; 60 % male; M age = 44.26, SD = 10.81) with moderate-to-severe AUD were randomized to ibudilast (50 mg twice daily) or placebo for 12 weeks. Pain intensity and disability were assessed at baseline using the Graded Chronic Pain Scale. Piecewise linear mixed-effects models tested the moderating effect of pain on percent heavy drinking days (PHDD), percent days abstinent, drinks per day, and drinks per drinking day, adjusting for early (baseline–Week 2) and late (Weeks 4–12) trial phases. Results: Pain variables were not significantly correlated with any drinking outcome at baseline (all |r| ≤ .08, p > .45). Significant three-way interactions (Medication × Pain Intensity × Time) emerged for PHDD in both early and late phases (ps < 0.05), indicating that higher pain intensity predicted greater PHDD in the placebo arm (b = 0.10, p = .04) but not in the ibudilast arm (b = 0.007, p ≥ .89). Similar interactions were observed for pain intensity and pain-related disability on drinks per day, though simple slopes were nonsignificant. No significant moderation effects were found for percent days abstinent or…
How strong is the evidence?
Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 102 participants or records.
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