Targeted Interventions for Weight-Concerned Smokers
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Intervention: Naltrexone; Transdermal nicotine replacement; Behavioral counseling
Intervention description: Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks; 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; 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.
Intervention MeSH terms: Naltrexone; Nicotine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 172.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Tobacco; Smoking; Weight; Weight perception; Naltrexone

Summary:

      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.
    

Eligibility 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.