Patient-reported side effects of buprenorphine-naloxone: identifying independent predictors from patient views and clinical assessment during maintenance treatment of heroin use disorder

Abstract

To identify the factors independently associated with patient-reported side effects of buprenorphine/naloxone (B/N) tablets. METHODS: 313 heroindependent patients receiving B/N maintenance treatment at least for the last 3 months were surveyed at 16 addiction treatment centers. Participants were not presented with a list of common side effects of B/N. Instead, patient-reported side effects were assessed by a question that they could answer by noting the perceived side effects or by the word "none” when appropriate. Fifty-three variables involving viral infections, self-reported substance use, pharmacological treatment including patients’ views on B/N treatment, and psychological adjustment were considered candidate predictors of patient-reported side effects. The Scale to Assess Satisfaction with Medications for Addiction Treatment e B/N for heroin addiction (SASMATBUNHER), the Opioid Dosage Adequacy Scale (ODAS), and the 28-item General Health Questionnaire (GHQ-28) were used to measure, respectively, patient satisfaction with B/N, buprenorphine dosage adequacy according to clinician, and psychological adjustment. Differences between patients who reported side effects (n ¼ 100) and patients who did not report them (n ¼ 213) were tested at bivariate level; only those variables that reached P-value .010 were subsequently included into a binary logistic regression analysis. RESULTS: On the regression model (HosmerLemeshow Test: c2 (8)¼ 5.070; P ¼ .750; Nagelkerke R2 ¼ .285), the factors associated with patient-reported B/N side effects were: Objective Opiate Withdrawal Symptoms subscale score of ODAS (b ¼ -.553), age of onset of heroin use (b ¼ .050), Personal Functioning subscale score of SASMAT-BUNHER (b ¼ -.620), and Somatic Symptoms subscale score of GHQ-28 (b ¼ .228). CONCLUSIONS: Clinician-assessed inadequate buprenorphine dosage regarding objective opiate withdrawal symptoms, later age of onset of heroin use, patient dissatisfaction with the compatibility of B/N with personal functioning, and psychological maladjustment regarding somatic symptoms are potential indicators of heroin-dependent patient-reported side effects of B/N in usual clinical practice.