Abstract

ABSTRACTBACKGROUNDVarenicline may be associated with greater mood disturbance and side-effects among smokers with psychiatric history, but empirical evidence is limited. Differential treatment effectiveness by psychiatric history may also exist.OBJECTIVETo compare mood, prevalence and intensity of treatment side-effects, and abstinence among people with a probable history of major depression (DH+) or not (DH−) who took varenicline and received behavioral smoking cessation treatment.DESIGNSmokers participated in a randomized behavioral intervention effectiveness trial. Treatment side-effects and outcomes were compared between DH+ and DH− participants (n = 1,117) at 2 days and 3 months after the target quit date.PARTICIPANTSSmokers recruited from a large regional health plan.MEASUREMENTSChange in stress and depression scores, prevalence and intensity of treatment side-effects, and abstinence rates.RESULTSAll side-effects averaged moderate intensity or less and were similar across DH groups, except DH+’s endorsed slightly worse confusion, nausea (adjusted P = 0.04) and trouble sleeping (adjusted P = 0.008) at 21 days. Depression and stress scores declined in both DH groups and an equal proportion of each evidenced new/worsening depressive symptoms. Despite few differences in symptom intensity, more DH+ participants reported recent tension/agitation, irritability/anger, confusion, and depression at 21 days (adjusted P < 0.05), and depression and anxiety (adjusted P < 0.01) at three months. Nonsmoking rates did not differ by DH group at follow-up.CONCLUSIONWhile some group differences were noted, DH+ smokers did not report qualitatively worse neuropsychiatric symptoms, more new/worsening mood disturbance, or differential abstinence rates compared to DH- smokers.

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