Addiction (Abingdon, England) · 2014
Varenicline efficacy and safety among methadone maintained smokers: a randomized placebo-controlled trial.
Клиническое исследование IV фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка NIH: внешняя программаНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Nahvi Shadi, Ning Yuming, Segal Kate S, Richter Kimber P, Arnsten Julia H
Аннотация
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 1 mg 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.
DESIGN: Multicenter, randomized, double-blind, placebo-controlled trial with random assignment to 12 weeks of varenicline 1 mg 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.