Expired Study
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New Haven, Connecticut 06511


Purpose:

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.


Study summary:

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.


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.


NCT ID:

NCT00105482


Primary Contact:

Principal Investigator
Stephanie O'Malley, PhD
Yale School of Medicine


Backup Contact:

N/A


Location Contact:

New Haven, Connecticut 06511
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 17, 2017

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