Low-dose naltrexone augmentation of nicotine replacement for smoking cessation with reduced weight gain: a randomized trial.
BACKGROUND
Fear of weight gain is a significant obstacle to smoking cessation, preventing some smokers from attempting to quit. Several previous studies of naltrexone yielded promising results for minimization of post-quit weight gain. Given these encouraging findings, we endeavored to test whether minimization of weight gain might translate to better quit outcomes for a population that is particularly concerned about gaining weight upon quitting.


METHODS
Smokers (N=172) in this investigation were prospectively randomized to receive either 25 mg naltrexone or placebo for 27 weeks (1 week pre-, 26 weeks post-quit) for minimization of post-quit weight gain and smoking cessation. All participants received open label therapy with the nicotine patch for the first 8 weeks post-quit and behavioral counseling over the 27-week treatment. The 2 pre-specified primary outcomes were change in weight for continuously abstinent participants and biologically verified end-of-treatment 7-day point-prevalence abstinence at 26 weeks after the quit date.


RESULTS
The difference in weight at 26 weeks post-quit between the naltrexone and placebo groups (naltrexone: 6.8 lbs ± 8.94 vs placebo: 9.7 lbs ± 9.19, p = 0.45) was not statistically different. Seven-day point-prevalence smoking abstinence rates at 26 weeks post-quit was not significantly different between the 2 groups (naltrexone: 22% vs placebo: 27%, p = 0.43).


CONCLUSIONS
For smokers high in weight concern, the relatively small reduction in weight gain with low-dose naltrexone is not worth the potential for somewhat lower rates of smoking abstinence.
Toll
Benjamin A
BA
Yale University School of Medicine, New Haven, CT 06519, USA; Yale Cancer Center, New Haven, CT 06519, USA.
White
Marney
M
Wu
Ran
R
Meandzija
Boris
B
Jatlow
Peter
P
Makuch
Robert
R
O'Malley
Stephanie S
SS
D000279:Administration, Cutaneous; D000328:Adult; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009271:Naltrexone / Q000008:administration & dosage*; D009538:Nicotine / Q000008:administration & dosage*; D011446:Prospective Studies; D012907:Smoking / Q000188:drug therapy* / Q000503:physiopathology; D016540:Smoking Cessation / Q000379:methods*; D015430:Weight Gain / Q000187:drug effects* / Q000502:physiology
D009271:Naltrexone; D009538:Nicotine