Varenicline efficacy and safety among methadone maintained smokers: A randomized placebo-controlled trial

Shadi Nahvi, Yuming Ning, Kate S. Segal, Kimber P. Richter, Julia H. Arnsten

Research output: Contribution to journalArticle

20 Citations (Scopus)

Abstract

Aims: To test the efficacy and safety of varenicline as an aid to smoking cessation in methadone-maintained smokers. Design: Multicenter, randomized, double-blind, placebo-controlled trial with random assignment to 12 weeks of varenicline 1mg twice daily (n=57) or matched placebo (n=55), with in-person and telephone counseling. Setting: Urban methadone programs in the Bronx, New York City, New York, USA. Participants: Methadone maintenance patients, smoking ≥5 cigarettes/day, interested in quitting, stable in methadone treatment, without current Axis I psychiatric disorders, suicidal ideation or recent suicide attempts. Measurements: Seven-day point prevalence abstinence verified by expired carbon monoxide (CO)<8 parts per million at week 12 (primary outcome); carbon monoxide (CO)-verified abstinence, cigarettes/day, incident Axis I psychiatric illness, suicidal ideation or serious adverse events (SAEs) at weeks 2, 4, 8, 12 or 24 (secondary outcomes). Findings: Baseline demographic, smoking and clinical factors were similar between groups. Retention at 24 weeks was 90%. Subjects receiving varenicline were more likely than those receiving placebo to achieve abstinence (10.5 versus 0%, P=0.03; effect size 10.5%, 95% confidence interval (CI)=4.4-19.3%) and to reduce smoking (median five versus two cigarettes/day, P<0.001) at 12 weeks. These effects were not maintained after drug treatment ceased. Incident psychiatric illness (OR=0.84, 95% CI=0.16, 4.4) and suicidality [odds ratio (OR)=0.88, 95% CI 0.2, 3.9] were not different between groups. There were no psychiatric or cardiac SAEs. Conclusions: Varenicline can aid short-term smoking abstinence in methadone-maintained smokers.

Original languageEnglish (US)
Pages (from-to)1554-1563
Number of pages10
JournalAddiction
Volume109
Issue number9
DOIs
StatePublished - Sep 1 2014

Fingerprint

Methadone
Randomized Controlled Trials
Placebos
Psychiatry
Safety
Smoking
Suicidal Ideation
Confidence Intervals
Carbon Monoxide
Tobacco Products
Odds Ratio
Smoking Cessation
Telephone
Suicide
Counseling
Demography
Varenicline
Therapeutics
Pharmaceutical Preparations

Keywords

  • Methadone maintenance
  • Opioid dependence
  • Smoking cessation
  • Varenicline

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Psychiatry and Mental health

Cite this

Varenicline efficacy and safety among methadone maintained smokers : A randomized placebo-controlled trial. / Nahvi, Shadi; Ning, Yuming; Segal, Kate S.; Richter, Kimber P.; Arnsten, Julia H.

In: Addiction, Vol. 109, No. 9, 01.09.2014, p. 1554-1563.

Research output: Contribution to journalArticle

Nahvi, Shadi ; Ning, Yuming ; Segal, Kate S. ; Richter, Kimber P. ; Arnsten, Julia H. / Varenicline efficacy and safety among methadone maintained smokers : A randomized placebo-controlled trial. In: Addiction. 2014 ; Vol. 109, No. 9. pp. 1554-1563.
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abstract = "Aims: To test the efficacy and safety of varenicline as an aid to smoking cessation in methadone-maintained smokers. Design: Multicenter, randomized, double-blind, placebo-controlled trial with random assignment to 12 weeks of varenicline 1mg twice daily (n=57) or matched placebo (n=55), with in-person and telephone counseling. Setting: Urban methadone programs in the Bronx, New York City, New York, USA. Participants: Methadone maintenance patients, smoking ≥5 cigarettes/day, interested in quitting, stable in methadone treatment, without current Axis I psychiatric disorders, suicidal ideation or recent suicide attempts. Measurements: Seven-day point prevalence abstinence verified by expired carbon monoxide (CO)<8 parts per million at week 12 (primary outcome); carbon monoxide (CO)-verified abstinence, cigarettes/day, incident Axis I psychiatric illness, suicidal ideation or serious adverse events (SAEs) at weeks 2, 4, 8, 12 or 24 (secondary outcomes). Findings: Baseline demographic, smoking and clinical factors were similar between groups. Retention at 24 weeks was 90{\%}. Subjects receiving varenicline were more likely than those receiving placebo to achieve abstinence (10.5 versus 0{\%}, P=0.03; effect size 10.5{\%}, 95{\%} confidence interval (CI)=4.4-19.3{\%}) and to reduce smoking (median five versus two cigarettes/day, P<0.001) at 12 weeks. These effects were not maintained after drug treatment ceased. Incident psychiatric illness (OR=0.84, 95{\%} CI=0.16, 4.4) and suicidality [odds ratio (OR)=0.88, 95{\%} CI 0.2, 3.9] were not different between groups. There were no psychiatric or cardiac SAEs. Conclusions: Varenicline can aid short-term smoking abstinence in methadone-maintained smokers.",
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AU - Arnsten, Julia H.

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N2 - Aims: To test the efficacy and safety of varenicline as an aid to smoking cessation in methadone-maintained smokers. Design: Multicenter, randomized, double-blind, placebo-controlled trial with random assignment to 12 weeks of varenicline 1mg twice daily (n=57) or matched placebo (n=55), with in-person and telephone counseling. Setting: Urban methadone programs in the Bronx, New York City, New York, USA. Participants: Methadone maintenance patients, smoking ≥5 cigarettes/day, interested in quitting, stable in methadone treatment, without current Axis I psychiatric disorders, suicidal ideation or recent suicide attempts. Measurements: Seven-day point prevalence abstinence verified by expired carbon monoxide (CO)<8 parts per million at week 12 (primary outcome); carbon monoxide (CO)-verified abstinence, cigarettes/day, incident Axis I psychiatric illness, suicidal ideation or serious adverse events (SAEs) at weeks 2, 4, 8, 12 or 24 (secondary outcomes). Findings: Baseline demographic, smoking and clinical factors were similar between groups. Retention at 24 weeks was 90%. Subjects receiving varenicline were more likely than those receiving placebo to achieve abstinence (10.5 versus 0%, P=0.03; effect size 10.5%, 95% confidence interval (CI)=4.4-19.3%) and to reduce smoking (median five versus two cigarettes/day, P<0.001) at 12 weeks. These effects were not maintained after drug treatment ceased. Incident psychiatric illness (OR=0.84, 95% CI=0.16, 4.4) and suicidality [odds ratio (OR)=0.88, 95% CI 0.2, 3.9] were not different between groups. There were no psychiatric or cardiac SAEs. Conclusions: Varenicline can aid short-term smoking abstinence in methadone-maintained smokers.

AB - Aims: To test the efficacy and safety of varenicline as an aid to smoking cessation in methadone-maintained smokers. Design: Multicenter, randomized, double-blind, placebo-controlled trial with random assignment to 12 weeks of varenicline 1mg twice daily (n=57) or matched placebo (n=55), with in-person and telephone counseling. Setting: Urban methadone programs in the Bronx, New York City, New York, USA. Participants: Methadone maintenance patients, smoking ≥5 cigarettes/day, interested in quitting, stable in methadone treatment, without current Axis I psychiatric disorders, suicidal ideation or recent suicide attempts. Measurements: Seven-day point prevalence abstinence verified by expired carbon monoxide (CO)<8 parts per million at week 12 (primary outcome); carbon monoxide (CO)-verified abstinence, cigarettes/day, incident Axis I psychiatric illness, suicidal ideation or serious adverse events (SAEs) at weeks 2, 4, 8, 12 or 24 (secondary outcomes). Findings: Baseline demographic, smoking and clinical factors were similar between groups. Retention at 24 weeks was 90%. Subjects receiving varenicline were more likely than those receiving placebo to achieve abstinence (10.5 versus 0%, P=0.03; effect size 10.5%, 95% confidence interval (CI)=4.4-19.3%) and to reduce smoking (median five versus two cigarettes/day, P<0.001) at 12 weeks. These effects were not maintained after drug treatment ceased. Incident psychiatric illness (OR=0.84, 95% CI=0.16, 4.4) and suicidality [odds ratio (OR)=0.88, 95% CI 0.2, 3.9] were not different between groups. There were no psychiatric or cardiac SAEs. Conclusions: Varenicline can aid short-term smoking abstinence in methadone-maintained smokers.

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