Targeted Interventions for Weight-Concerned Smokers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Testing the Effectiveness of Low Dose Naltrexone for Smoking Cessation and Minimization of Post-cessation Weight Gain

Conditions
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Nicotine Dependence

Intervention / Treatment
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* Drug: Naltrexone
* Drug: Transdermal nicotine replacement
* Behavioral: Behavioral counseling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Naltrexone, Transdermal Nicotine<br>Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day | Drug: Naltrexone<br>* Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks<br>Drug: Transdermal nicotine replacement<br>* Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day<br>Behavioral: Behavioral counseling<br>* 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.<br>|
| Placebo Comparator: Placebo Naltrexone, Transdermal Nicotine<br>Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day | Drug: Transdermal nicotine replacement<br>* Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day<br>Behavioral: Behavioral counseling<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Gain at 26 Weeks. | Weight change from baseline measured at 26 weeks. | 26 weeks | 
| Point Prevalence Smoking Abstinence at 26 Weeks. | The number of people that were abstinent from cigarette smoking at 26 weeks. | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Gain at 6 Weeks. | Weight change from baseline measured at 6 weeks. | 6 weeks | 
| Point Prevalence Smoking Abstinence at 6 Weeks | The number of people that were abstinent from cigarette smoking at 6 weeks. | 6 weeks | 
| Cigarettes Smoked Per Day. | Average number of cigarettes smoked per day at 26 weeks. | 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tobacco, Smoking, Weight, Weight perception, Naltrexone