Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2009 May;24(5):563-9.
doi: 10.1007/s11606-009-0926-8. Epub 2009 Feb 24.

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

Jennifer B McClure  1 , Gary E Swan, Lisa Jack, Sheryl L Catz, Susan M Zbikowski, Tim A McAfee, Mona Deprey, Julie Richards, Harold Javitz
Affiliations
Randomized Controlled Trial

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

Jennifer B McClure et al. J Gen Intern Med. 2009 May.

Erratum in

  • J Gen Intern Med. 2009 Oct;24(10):1173

Abstract

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 21 [corrected] 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.

Trial registration: ClinicalTrials.gov NCT00301145.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Change in depression score from baseline to follow-up*. *Scores reflect unadjusted means, with 95% confidence intervals indicated for each data point. Adjusted mean change from baseline to each follow-up is presented in the text and was significantly greater for DH– participants at each follow-up. † DH+ participants indicated a probable history of prior major depression at baseline. DH – participants denied symptoms suggestive of a probable lifetime major depression episode. ‡ Depression symptom scores range from 0 to 4 and reflect symptoms over the past month. Higher scores indicate greater depression.
Figure 2
Figure 2
Change in perceived stress score from baseline to follow-up*. *Scores reflect unadjusted means with 95% confidence intervals indicated for each data point. Adjusted mean change from baseline to each follow-up is presented in the text and was significantly greater for DH- participants at each follow-up. † DH+ participants indicated a probable history of prior major depression at baseline. DH – participants denied symptoms suggestive of a probable lifetime major depression episode. ‡ Perceived stress scores range from 0 to 16 and reflect symptoms over the past month. Higher scores indicate greater perceived stress, a subjective measure of distress.
See this image and copyright information in PMC

References

    1. {'text': '', 'ref_index': 1, 'ids': [{'type': 'DOI', 'value': '10.1001/jama.296.1.47', 'is_inner': False, 'url': 'https://doi.org/10.1001/jama.296.1.47'}, {'type': 'PubMed', 'value': '16820546', 'is_inner': True, 'url': 'https://pubmed.ncbi.nlm.nih.gov/16820546/'}]}
    2. Gonzales D, Rennard SI, Nides M. Varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs sustained-release bupropion and placebo for smoking cessation: a randomized controlled trial. JAMA. 2006;296:47–55. - PubMed
    1. {'text': '', 'ref_index': 1, 'ids': [{'type': 'DOI', 'value': '10.1001/jama.296.1.56', 'is_inner': False, 'url': 'https://doi.org/10.1001/jama.296.1.56'}, {'type': 'PubMed', 'value': '16820547', 'is_inner': True, 'url': 'https://pubmed.ncbi.nlm.nih.gov/16820547/'}]}
    2. Jorenby DE, Hays JT, Rigotti NA. Efficacy of varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs placebo or sustained-release bupropion for smoking cessation: a randomized controlled trial. JAMA. 2006;296:56–63. - PubMed
    1. {'text': '', 'ref_index': 1, 'ids': [{'type': 'DOI', 'value': '10.1001/archinte.166.15.1561', 'is_inner': False, 'url': 'https://doi.org/10.1001/archinte.166.15.1561'}, {'type': 'PubMed', 'value': '16908788', 'is_inner': True, 'url': 'https://pubmed.ncbi.nlm.nih.gov/16908788/'}]}
    2. Nides M, Oncken C, Gonzales D. Smoking cessation with varenicline, a selective alpha4beta2 nicotinic receptor partial agonist: results from a 7-week, randomized, placebo- and bupropion-controlled trial with 1-year follow-up. Arch Intern Med. 2006;166:1561–8. - PubMed
    1. {'text': '', 'ref_index': 1, 'ids': [{'type': 'DOI', 'value': '10.1001/archinte.166.15.1571', 'is_inner': False, 'url': 'https://doi.org/10.1001/archinte.166.15.1571'}, {'type': 'PubMed', 'value': '16908789', 'is_inner': True, 'url': 'https://pubmed.ncbi.nlm.nih.gov/16908789/'}]}
    2. Oncken C, Gonzales D, Nides M. Efficacy and safety of the novel selective nicotinic acetylcholine receptor partial agonist, varenicline, for smoking cessation. Arch Intern Med. 2006;166:1571–7. - PubMed
    1. {'text': '', 'ref_index': 1, 'ids': [{'type': 'DOI', 'value': '10.1001/jama.296.1.64', 'is_inner': False, 'url': 'https://doi.org/10.1001/jama.296.1.64'}, {'type': 'PubMed', 'value': '16820548', 'is_inner': True, 'url': 'https://pubmed.ncbi.nlm.nih.gov/16820548/'}]}
    2. Tonstad S, Tonnesen P, Hajek P, Williams KE, Billing CB, Reeves KR. Effect of maintenance therapy with varenicline on smoking cessation: a randomized controlled trial. JAMA. 2006;296:64–71. - PubMed

Publication types

MeSH terms

Associated data