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
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.
- 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.
- 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
- 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.