title: Low-dose naltrexone augmentation of nicotine replacement for smoking cessation with reduced weight gain: a randomized trial.
abstract: 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.
authors.affiliation: Yale University School of Medicine, New Haven, CT 06519, USA; Yale Cancer Center, New Haven, CT 06519, USA.
authors.forename: Benjamin A
authors.initials: BA
authors.lastname: Toll
authors.forename: Marney
authors.initials: M
authors.lastname: White
authors.forename: Ran
authors.initials: R
authors.lastname: Wu
authors.forename: Boris
authors.initials: B
authors.lastname: Meandzija
authors.forename: Peter
authors.initials: P
authors.lastname: Jatlow
authors.forename: Robert
authors.initials: R
authors.lastname: Makuch
authors.forename: Stephanie S
authors.initials: SS
authors.lastname: O'Malley
mesh_terms: 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
chemical_list: D009271:Naltrexone; D009538:Nicotine