title: Exploring the impact of gender and reproductive status on outcomes in a randomized clinical trial of naltrexone augmentation of nicotine patch.
abstract: In a series of exploratory analyses, we examined the roles of gender, reproductive status and negative affect on smoking abstinence in subjects participating in a large (n=385) 6-week randomized clinical trial (RCT) of nicotine patch therapy, with varying doses of oral naltrexone (0mg, 25mg, 50mg, 100mg) treatment. Negative affect was assessed daily during the first post-quit week via telephone interactive voice response (IVR). Weight and adverse events were recorded weekly. In the intent to treat sample, the effects of dose on continuous abstinence were non-significant in the overall model for men and women. In the 295 study completers, there was a significant effect of dose on continuous abstinence in women only (F=8.53, p=0.04). In the 100mg group, 71% of women were continuously abstinent compared to 41% in the placebo group (p<0.05). Women in the active naltrexone groups gained less weight (F=2.91, df=3, p=0.04). Women in the 100mg vs. placebo group were less adherent with medication (F=3.19, p<0.05). These effects were not significant in men. Naltrexone treatment condition (100mg vs. placebo, p=0.02, odds ratio (OR)=0.28), gender (OR=0.55 p=0.09), and IVR ratings of negative affect (OR 1.02, p=0.04) predicted abstinence at Week 1 in study completers. Menstrual cycle status on quit day had a modest affect on abstinence. These data suggest that naltrexone dose, gender, and negative affect play a role in smoking abstinence, particularly in the early stages of treatment. When used in conjunction with nicotine replacement therapy, naltrexone dose may be important in women.
authors.affiliation: University of Pennsylvania School of Medicine, Department of Psychiatry, Philadelphia, PA 19104-3309, USA. cepp@mail.med.upenn.edu
authors.forename: C Neill
authors.initials: CN
authors.lastname: Epperson
authors.forename: Benjamin
authors.initials: B
authors.lastname: Toll
authors.forename: Ran
authors.initials: R
authors.lastname: Wu
authors.forename: Zenab
authors.initials: Z
authors.lastname: Amin
authors.forename: Kathryn A
authors.initials: KA
authors.lastname: Czarkowski
authors.forename: Peter
authors.initials: P
authors.lastname: Jatlow
authors.forename: Carolyn M
authors.initials: CM
authors.lastname: Mazure
authors.forename: Stephanie S
authors.initials: SS
authors.lastname: O'Malley
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001835:Body Weight / Q000187:drug effects; D005260:Female; D006801:Humans; D007407:Interviews as Topic; D008297:Male; D055118:Medication Adherence; D008597:Menstrual Cycle; D008875:Middle Aged; D009271:Naltrexone / Q000009:adverse effects / Q000627:therapeutic use*; D009292:Narcotic Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D009538:Nicotine / Q000008:administration & dosage* / Q000009:adverse effects; D012727:Sex Characteristics; D016540:Smoking Cessation; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D009292:Narcotic Antagonists; D009271:Naltrexone; D009538:Nicotine