A randomized trial of bupropion and/or nicotine gum as maintenance treatment for preventing smoking relapse

• Published in: Addiction (Abingdon, England) Vol. 102; no. 8; pp. 1292 - 1302
• Main Authors: Covey, Lirio S., Glassman, Alexander H., Jiang, Huiping, Fried, Jane, Masmela, Jenny, LoDuca, Catherine, Petkova, Eva, Rodriguez, Kristina
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01-08-2007; Blackwell
• Subjects: Addiction; Addictive behaviors; Adult; Adult and adolescent clinical studies; Behaviourism; Biological and medical sciences; Bupropion; Bupropion - administration & dosage; Bupropion - adverse effects; Cessation; Clinical outcomes; Dopamine Uptake Inhibitors - administration & dosage; Dopamine Uptake Inhibitors - adverse effects; Double-Blind Method; Female; Humans; maintenance treatment; Male; Medical sciences; Medical treatment; Morbidity; Mortality; Nicotine - administration & dosage; Nicotine - adverse effects; Nicotine - analogs & derivatives; Nicotine gum; Patient Compliance - statistics & numerical data; Placebos; Polymethacrylic Acids - administration & dosage; Polymethacrylic Acids - adverse effects; Polyvinyls - administration & dosage; Polyvinyls - adverse effects; Prevention and actions; Psychology. Psychoanalysis. Psychiatry; Psychopathology. Psychiatry; Public health. Hygiene; Public health. Hygiene-occupational medicine; Relapse; Secondary Prevention; Smoking; smoking cessation; Smoking Prevention; smoking relapse; Therapy; Tobacco smoking; Tobacco Use Cessation Products; Tobacco, tobacco smoking; Toxicology; Treatment Methods; Treatment Outcome; Treatment Outcomes; Human; Drug addiction; Relapse; Poison withdrawal; Psychotropic; Tobacco smoking; Prevention; Alkaloid; Randomization; Tobacco; nicotine gum; Bupropion; Addiction; Shutdown; smoking cessation; Maintenance treatment; Antidepressant agent; Clinical trial; Psychiatry; Nicotine; smoking relapse
• ISSN: 0965-2140; 1360-0443
• DOI: 10.1111/j.1360-0443.2007.01887.x

ABSTRACT
Aim  To investigate the efficacy of maintenance treatment with bupropion and/or nicotine gum for reducing smoking relapse.
Design, setting and participants  A 48‐week study was conducted at a university‐based smoking cessation clinic between February 2001 and October 2005. A total of 588 smokers received bupropion and nicotine patch in 8 weeks of open‐label treatment (OLT); 289 abstainers during the last 4 weeks of OLT were randomized in double‐blind placebo‐controlled fashion to one of four arms for 16 weeks of maintenance treatment (MT) followed by 24 weeks of non‐treatment follow‐up (NTFU).
Intervention  Bupropion (300 mg/day) and 2 mg nicotine gum, used alone or combined, and comparable placebo pill and placebo gum. Behavioral counseling at all visits.
Outcome  Time to relapse (TTR) from randomization. Relapse is defined as the first 7 consecutive days of smoking. Abstinence verified by carbon monoxide ≤ 8 parts per million.
Findings  TTR was longer with extended active treatments compared to placebo (median days to relapse: bupropion + placebo = 136, nicotine + placebo = 98, bupropion + nicotine = 90, double placebo = 71). Hazard ratios (HR) for relapse were statistically significant for bupropion + placebo versus double placebo during MT (HR = 0.59, 95% CI = 0.37–0.92) and to the end of NTFU (HR = 0.66, 95% CI = 0.42–0.96). However, bupropion's advantage dissipated upon stopping the drug. Gum use was low, preventing a valid assessment; but analysis restricted to gum users suggested a weak effect of extended nicotine gum.
Conclusion  Maintenance treatment with bupropion exerted a modest benefit for preventing smoking relapse; the optimum duration of bupropion treatment was unclear. Further research is needed to ascertain the merits of extended use of nicotine gum, other nicotine replacement agents and other treatments known to aid smokers for preventing relapse once abstinence is achieved.