Expired Study
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New Haven, Connecticut 06511


Purpose:

This study will test a combination of the drugs naltrexone and bupropion with weight-concerned smokers to investigate whether or not this combination of drugs improves smoking cessation quit rates and minimizes post quit weight gain.


Study summary:

This is an open label smoking cessation clinical trial of 25 mg naltrexone with 300 mg bupropion sustained-release (SR) in six male and fourteen female participants. This pilot study is being conducted to determine: - effect size estimates for smoking cessation and post-cessation weight gain, which will be used to compute the sample size needed for a large-scale clinical trial; and - compliance with a combination of 25 mg naltrexone and 300 mg bupropion SR. In addition to examining the sample in this study, the investigators plan to compare this sample to a sample of matched controls.


Criteria:

Inclusion Criteria: - Ages 18 and older - Willingness and ability to give written consent - Smoking at least 10 cigarettes per day for at least 1 year - Baseline expired carbon-monoxide level of at least 10 ppm - Weigh at least 100 lbs. - English-speaking - One person per household - At least 1 prior quit attempt - Concern about gaining weight. This will be assessed using a questionnaire that will provide a rating system to determine qualified participants. Exclusion Criteria: - Pregnant or nursing women or women attempting to conceive - Serious current neurologic, psychiatric or medical illness, including unstable cardiac, hepatic, or renal disease and diabetes and hypertension - Current alcohol dependence - Current use of opiates, and/or a urine toxicology screen positive for opiates - Chronic pain conditions necessitating opioid treatment (naltrexone, an opioid antagonist will make these medications ineffective) - Evidence of significant hepatocellular injury as evidenced by AST or ALT >3 x normal or elevated bilirubin - History of cirrhosis - Body mass index (BMI) greater than 35 - History of anorexia nervosa or bulimia - Current major depression - Currently taking Toprol-XL (or metoprolol succinate) - History of seizure disorder or serious brain injury - Current use of smokeless tobacco, pipes, cigars, nicotine gum, nicotine patch, nicotine inhaler, nicotine lozenge, nicotine nasal spray, or bupropion - Previous hypersensitivity to bupropion - Patients requiring concomitant therapy with any psychotropic drug - Participation in the Framing Messages for Smoking Cessation With Bupropion study (HIC#: 10880)


NCT ID:

NCT00129246


Primary Contact:

Principal Investigator
Benjamin Toll, Ph.D.
Yale University School of Medicine Department of Psychiatry


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: June 25, 2018

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