Current pharmacological treatments for smoking cessation including nicotine replacement therapies and buproprion, are modestly successful in assisting smokers to quit. However, new treatments are needed. In particular, the problem of weight gain with smoking cessation is only partially reduced by current therapies. Furthermore, treatments that might address the link between alcohol consumption and smoking relapse may be particularly useful since many smokers are heavy drinkers, and this subgroup is particularly resistant to treatment. Based on our preliminary studies, we hypothesize that naltrexone, an opioid antagonist approved for the treatment of alcohol dependence, may be useful in augmenting the efficacy of transdermal nicotine replacement on rates of continuous abstinence and in preventing weight gain with smoking cessation. In the proposed study, we will test this hypothesis in 400 smokers seeking to quit smoking. All subjects will receive nicotine replacement therapy, and will be randomized to receive one of four doses of naltrexone (0, 25 mg, 50mg, or 100 mg daily) for six weeks following their quit date. Primary outcomes will be continuous abstinence during the last four weeks of treatment and weight gain. Secondary outcomes will include measures of craving for cigarettes, sweet and rich foods, and alcohol use. Through a careful analysis of data collected during the first week following their quit date, we will evaluate whether naltrexone treatment reduces the probability of continued smoking following their quit date, we will evaluate whether naltrexone treatment reduces the probability of continued smoking following a lapse in abstinence and the relationship between alcohol consumption and smoking relapse. A secondary aim of the study will be to explore predictors of response to treatment, including biochemical and neuroendocrine measures (e.g., baseline cotinine, naltrexone metabolite levels, cortisol levels), demographic characteristics (e.g., age/sex) and alcohol use history.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Specialized Center (P50)
Project #
1P50DA013334-01
Application #
6261659
Study Section
Special Emphasis Panel (ZCA1-SRRB-Y (O1))
Project Start
1999-09-30
Project End
2004-08-31
Budget Start
Budget End
Support Year
1
Fiscal Year
1999
Total Cost
Indirect Cost
Name
Yale University
Department
Type
DUNS #
082359691
City
New Haven
State
CT
Country
United States
Zip Code
06520
Geha, Paul; Cecchi, Guillermo; Todd Constable, R et al. (2017) Reorganization of brain connectivity in obesity. Hum Brain Mapp 38:1403-1420
Roberts, Walter; Verplaetse, Terril L; Moore, Kelly et al. (2017) Effects of varenicline on alcohol self-administration and craving in drinkers with depressive symptoms. J Psychopharmacol 31:906-914
Corbin, William R; Papova, Anna; Morean, Meghan E et al. (2015) Integrating acquired preparedness and dual process models of risk for heavy drinking and related problems. Psychol Addict Behav 29:864-74
Smith, Megan V; Ramsay, Christina; Mazure, Carolyn M (2014) Understanding disparities in subpopulations of women who smoke. Curr Addict Rep 1:69-74
Avery, Naomi; Kenny, Anne M; Kleppinger, Alison et al. (2014) Effects of varenicline, nicotine or placebo on depressive symptoms in postmenopausal smokers. Am J Addict 23:459-65
Morean, Meghan E; DeMartini, Kelly S; Leeman, Robert F et al. (2014) Psychometrically improved, abbreviated versions of three classic measures of impulsivity and self-control. Psychol Assess 26:1003-20
King, Andrea C; Cao, Dingcai; Zhang, Lingjiao et al. (2013) Naltrexone reduction of long-term smoking cessation weight gain in women but not men: a randomized controlled trial. Biol Psychiatry 73:924-30
Duncan, Lindsay R; Latimer, Amy E; Pomery, Elizabeth et al. (2013) Testing messages to encourage discussion of clinical trials among cancer survivors and their physicians: examining monitoring style and message detail. J Cancer Educ 28:119-26
Geha, Paul Y; Aschenbrenner, Katja; Felsted, Jennifer et al. (2013) Altered hypothalamic response to food in smokers. Am J Clin Nutr 97:15-22
Cosgrove, Kelly P; Esterlis, Irina; McKee, Sherry A et al. (2012) Sex differences in availability of ?2*-nicotinic acetylcholine receptors in recently abstinent tobacco smokers. Arch Gen Psychiatry 69:418-27

Showing the most recent 10 out of 96 publications