Randomized, double-blind, placebo-controlled trial of 2 dosages of sustained-release bupropion for adolescent smoking cessation

Myra L Muramoto, Scott J. Leischow, Duane L Sherrill, Eva Matthews, Louise J. Strayer

Research output: Contribution to journalArticle

53 Citations (Scopus)

Abstract

Objective: To assess the safety and efficacy of sustained-release bupropion hydrochloride for adolescent smoking cessation. Design: Prospective, randomized, double-blind, placebo-controlled, dose-ranging trial. Setting: Metropolitan areas of Tucson and Phoenix, Arizona. Participants: Adolescents (N=312) recruited through media and various community venues from March 1, 1999, through December 31, 2002, who were aged 14 to 17 years, smoked 6 or more cigarettes per day, had an exhaled carbon monoxide level of 10 ppm or greater, had at least 2 previous quit attempts, and had no other current major psychiatric diagnosis. Intervention: Sustained-release bupropion hydrochloride, 150 mg/d (n=105) or 300 mg/d (n=104), or placebo (n=103) for 6 weeks, plus weekly brief individual counseling. Subjects were followed up at 12 weeks (by telephone call) and 26 weeks. Main Outcome Measure: Confirmed 7-day point prevalence abstinence at 6 weeks and 30-day prolonged abstinence (carbon monoxide level <10 ppm at each visit; urinary cotinine level ≤50 μg/L at weeks 2 and 6). Results: Cotinine-confirmed 7-day point prevalence abstinence rates at 6 weeks were as follows: placebo, 5.6%; 150 mg, 10.7%; and 300 mg, 14.5% (P=.03, 300 mg vs placebo). At 26 weeks, confirmed point prevalence abstinence rates were as follows: placebo, 10.3%; 150 mg, 3.1%; and 300 mg, 13.9% (P=.049). During treatment, confirmed point prevalence rates were significantly higher for 300 mg than placebo at every week except week 4. Conclusions: Sustained-release bupropion hydrochloride, 300 mg/d, plus brief counseling demonstrated short-term efficacy for adolescent smoking cessation. Abstinence rates were lower than those reported for adults, with rapid relapse after medication discontinuation. Trial Registration: clinicaltrials.gov Identifier: NCT00344695

Original languageEnglish (US)
Pages (from-to)1068-1074
Number of pages7
JournalArchives of Pediatrics and Adolescent Medicine
Volume161
Issue number11
DOIs
StatePublished - Nov 2007

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Bupropion
Smoking Cessation
Placebos
Cotinine
Carbon Monoxide
Counseling
Telephone
Mental Disorders
Tobacco Products
Outcome Assessment (Health Care)
Safety
Recurrence

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

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Randomized, double-blind, placebo-controlled trial of 2 dosages of sustained-release bupropion for adolescent smoking cessation. / Muramoto, Myra L; Leischow, Scott J.; Sherrill, Duane L; Matthews, Eva; Strayer, Louise J.

In: Archives of Pediatrics and Adolescent Medicine, Vol. 161, No. 11, 11.2007, p. 1068-1074.

Research output: Contribution to journalArticle

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abstract = "Objective: To assess the safety and efficacy of sustained-release bupropion hydrochloride for adolescent smoking cessation. Design: Prospective, randomized, double-blind, placebo-controlled, dose-ranging trial. Setting: Metropolitan areas of Tucson and Phoenix, Arizona. Participants: Adolescents (N=312) recruited through media and various community venues from March 1, 1999, through December 31, 2002, who were aged 14 to 17 years, smoked 6 or more cigarettes per day, had an exhaled carbon monoxide level of 10 ppm or greater, had at least 2 previous quit attempts, and had no other current major psychiatric diagnosis. Intervention: Sustained-release bupropion hydrochloride, 150 mg/d (n=105) or 300 mg/d (n=104), or placebo (n=103) for 6 weeks, plus weekly brief individual counseling. Subjects were followed up at 12 weeks (by telephone call) and 26 weeks. Main Outcome Measure: Confirmed 7-day point prevalence abstinence at 6 weeks and 30-day prolonged abstinence (carbon monoxide level <10 ppm at each visit; urinary cotinine level ≤50 μg/L at weeks 2 and 6). Results: Cotinine-confirmed 7-day point prevalence abstinence rates at 6 weeks were as follows: placebo, 5.6{\%}; 150 mg, 10.7{\%}; and 300 mg, 14.5{\%} (P=.03, 300 mg vs placebo). At 26 weeks, confirmed point prevalence abstinence rates were as follows: placebo, 10.3{\%}; 150 mg, 3.1{\%}; and 300 mg, 13.9{\%} (P=.049). During treatment, confirmed point prevalence rates were significantly higher for 300 mg than placebo at every week except week 4. Conclusions: Sustained-release bupropion hydrochloride, 300 mg/d, plus brief counseling demonstrated short-term efficacy for adolescent smoking cessation. Abstinence rates were lower than those reported for adults, with rapid relapse after medication discontinuation. Trial Registration: clinicaltrials.gov Identifier: NCT00344695",
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