targeted interventions for weight-concerned smokers

Conditions: Nicotine Dependence

Summary: weight gain after quitting smoking is an important barrier to treatment for many smokers. this study will test a drug called naltrexone with weight-concerned smokers to investigate whether or not this drug both improves smoking cessation quit rates and minimizes post quit weight gain.

this is a 6-month randomized, double-blind, placebo controlled trial of 25 mg naltrexone for smoking cessation in a sample of 270 male and female weight-concerned smokers. participants also receive transdermal nicotine replacement therapy during the first 8 weeks of the study, which they begin on their quit date. naltrexone study medication will be started a week before their quit date and continued through the six-month period. brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter. a follow-up appointment is completed at 12 months after participants' quit date. the primary outcomes are six-month point prevalence abstinence and post-cessation weight gain for those who are continuously abstinent (not even a puff). secondary outcomes include an examination of alcohol consumption, evaluation of urges, other measures of smoking cessation success, point prevalence abstinence at 12 months, and food preferences. a number of tertiary measures will be obtained for examining predictors of smoking cessation, weight gain, and naltrexone response.

Eligibility criteria:
inclusion criteria: * 1. concern about gaining weight after quitting. this will be assessed using questionnaires that will provide a rating system to determine qualified participants. * 2. age 18 and older. * 3. willingness and ability to give written consent. * 4. smoking greater than 10 cigarettes per day for at least 1 year. * 5. at least one prior attempt to stop smoking. * 6. baseline expired carbon-monoxide level of at least 10 ppm. * 7. weigh at least 100 lbs. * 8. english speaking. * 9. one person per household. exclusion criteria: * 1. pregnant or nursing women or women attempting to conceive. * 2. unstable cardiac disease. * 3. history of dermatoses. * 4. current alcohol or drug dependence other than nicotine dependence. * 5. serious current neurologic, psychiatric or medical illness, including those with a significant risk of committing suicide based on history or investigator's judgment. * 6. chronic pain conditions necessitating opioid treatment (naltrexone, an opioid antagonist, will make these medications ineffective). * 7. history of cirrhosis or significant hepatocellular injury as evidenced by sgot or sgpt \>3 x normal or elevated bilirubin. * 8. current use of smokeless tobacco, pipes, cigars, nicotine gum, patch, nasal spray, inhaler, or lozenges. * 9. patients requiring concomitant therapy with any psychotropic drug or on any drug with a psychotropic component except those who are on a stable dose of an selective serotonin reuptake inhibitor for at least two months for the indications of major depressive disorder, premenstrual syndrome (pms) or premenstrual dysphoric disorder (pmdd). * 10. subjects with a positive opiate urine drug screen will be excluded to avoid precipitating opiate withdrawal. * 11. current use of opiates. * 12. currently on a medically prescribed diet.

Keywords: tobacco smoking weight weight perception naltrexone