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.

Condition	Treatment or Intervention	Phase
Nicotine Dependence	Drug: Naltrexone  Drug: Transdermal nicotine replacement  Behavior: Behavioral counseling	Phase II

Further Study Details: 

Primary Outcomes: Point prevalence smoking abstinence at 6 months; Weight gain at 6 months
Secondary Outcomes: Alcohol consumption; Craving for cigarettes; Other measures of smoking cessation success (e.g., continuous abstinence at 6 months); Point prevalence smoking abstinence at 12 months; Food preferences
Expected Total Enrollment:  270

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.

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 greater than 10 cigarettes per day for at least 1 year
• At least one prior attempt to stop smoking
• Baseline expired carbon-monoxide level of at least 10 ppm
• Weigh at least 100 lbs.
• English speaking
• One person per household

Exclusion Criteria:

• Pregnant or nursing women or women attempting to conceive
• Unstable cardiac disease
• History of dermatoses
• Current alcohol or drug dependence other than nicotine dependence
• Serious current neurologic, psychiatric or medical illness
• Chronic pain conditions necessitating opioid treatment (naltrexone, an opioid antagonist will make these medications ineffective)
• History of cirrhosis or of significant hepatocellular injury as evidenced by SGOT or SGPT >3 x normal or elevated bilirubin
• Current use of smokeless tobacco, pipes, cigars, nicotine gum, patch, lozenge, inhaler, or nasal spray
• Patients requiring concomitant therapy with any psychotropic drug or on any drug with a psychotropic component including buproprion
• Subjects with a positive opiate urine drug screen will be excluded to avoid precipitating opiate withdrawal
• Current use of opiates
• Currently on a medically prescribed diet

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

Study ID Numbers:  NIAAAOMA15632; 9 P50-AA15632
Record last reviewed:  March 2005
Last Updated:  March 28, 2005
Record first received:  March 14, 2005
ClinicalTrials.gov Identifier:  NCT00105482
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08