Mood, side-effects and smoking outcomes among persons with and without probable lifetime depression taking varenicline

Background: Varenicline 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. OBJECTIVE: To 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. DESIGN: Smokers 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. PARTICIPANTS: Smokers recruited from a large regional health plan. Measurements: Change in stress and depression scores, prevalence and intensity of treatment side-effects, and abstinence rates. Results: All 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. CONCLUSION: While 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.