Targeted Interventions for Weight-Concerned Smokers

Yale University

Status and phase: Completed; Phase 2

Conditions: Nicotine Dependence

Treatments: Drug: Transdermal nicotine replacement; Behavioral: Behavioral counseling; Drug: Naltrexone

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00105482

9P50AA015632 (U.S. NIH Grant/Contract)

NIAAAOMA15632

P50AA015632 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 172 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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172 participants in 2 patient groups, including a placebo group

Naltrexone, Transdermal Nicotine

Experimental group

Description:

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

Treatment:

Drug: Naltrexone

Drug: Transdermal nicotine replacement

Behavioral: Behavioral counseling

Placebo Naltrexone, Transdermal Nicotine

Placebo Comparator group

Description:

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

Treatment:

Drug: Transdermal nicotine replacement

Behavioral: Behavioral counseling