A randomized trial of bupropion and/or nicotine gum as maintenance treatment for preventing smoking relapse.
OBJECTIVE
To investigate the efficacy of maintenance treatment with bupropion and/or nicotine gum for reducing smoking relapse.


METHODS
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).


METHODS
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.


RESULTS
Time to relapse (TTR) from randomization. Relapse is defined as the first 7 consecutive days of smoking. Abstinence verified by carbon monoxide <or= 8 parts per million.


RESULTS
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.


CONCLUSIONS
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.
Covey
Lirio S
LS
Smoking Cessation Program, New York State Psychiatric Institute, Columbia University Medical Center, New York, NY 10032, USA. lsc3@columbia.edu
Glassman
Alexander H
AH
Jiang
Huiping
H
Fried
Jane
J
Masmela
Jenny
J
LoDuca
Catherine
C
Petkova
Eva
E
Rodriguez
Kristina
K
D000328:Adult; D016642:Bupropion / Q000008:administration & dosage* / Q000009:adverse effects; D018765:Dopamine Uptake Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D009538:Nicotine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D010349:Patient Compliance / Q000706:statistics & numerical data; D010919:Placebos; D011109:Polymethacrylic Acids / Q000008:administration & dosage* / Q000009:adverse effects; D011145:Polyvinyls / Q000008:administration & dosage* / Q000009:adverse effects; D055502:Secondary Prevention; D000074606:Smoking Prevention; D061485:Tobacco Use Cessation Devices; D016896:Treatment Outcome
D018765:Dopamine Uptake Inhibitors; D010919:Placebos; D011109:Polymethacrylic Acids; D011145:Polyvinyls; D016642:Bupropion; D009538:Nicotine