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.

Condition	Intervention	Phase
Smoking Nicotine Dependence	Drug: Naltrexone  Drug: Bupropion	Phase I Phase II

Further Study Details: 

Primary Outcomes: Weight gain and smoking cessation; Compliance with medication
Secondary Outcomes: Alcohol consumption; Tobacco and food craving; Adverse events
Expected Total Enrollment:  20

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: 1) 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 2) compliance with a combination of 25 mg naltrexone and 300 mg bupropion SR. In addition to examining the sample in this study, we plan to compare this sample to a sample of matched controls.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Age 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 evidence 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)

Please refer to this study by ClinicalTrials.gov identifier  NCT00129246

Benjamin A. Toll, Ph.D.      203-974-5767    benjamin.toll@yale.edu

Connecticut
      Yale University School of Medicine Substance Abuse Treatment Unit, New Haven,  Connecticut,  06511,  United States; Recruiting

Study chairs or principal investigators

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

Study ID Numbers:  NIAAAOMA15632-B; NIH Grant 9 P50-AA15632
Last Updated:  August 12, 2005
Record first received:  August 9, 2005
ClinicalTrials.gov Identifier:  NCT00129246
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-23