Targeted Interventions for Weight-Concerned Smokers

NCT ID: NCT00105482

Last Updated: 2013-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2009-10-31

Brief 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.

Detailed 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.

Conditions

Nicotine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Naltrexone, Transdermal Nicotine

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

Group Type: EXPERIMENTAL

Naltrexone

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Behavioral counseling

Intervention Type: BEHAVIORAL

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.

Placebo Naltrexone, Transdermal Nicotine

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

Group Type: PLACEBO_COMPARATOR

Transdermal nicotine replacement

Intervention Type: DRUG

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

Behavioral counseling

Intervention Type: BEHAVIORAL

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.

Interventions

Naltrexone

Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks

Intervention Type: DRUG

Transdermal nicotine replacement

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

Intervention Type: DRUG

Behavioral counseling

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 Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephanie O'Malley, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale University School of Medicine Substance Abuse Treatment Unit

New Haven, Connecticut, United States

Countries

United States

References

Toll BA, White M, Wu R, Meandzija B, Jatlow P, Makuch R, O'Malley SS. Low-dose naltrexone augmentation of nicotine replacement for smoking cessation with reduced weight gain: a randomized trial. Drug Alcohol Depend. 2010 Oct 1;111(3):200-6. doi: 10.1016/j.drugalcdep.2010.04.015. Epub 2010 Jun 12.

Reference Type: RESULT

PMID: 20542391 (View on PubMed)

Related Links

http://www.quitwithyale.org

This website describes the Transdisciplinary Tobacco Use Research Center at Yale University. Click here for more information about the study: Targeted Interventions for Weight-concerned Smokers.

Other Identifiers

P50AA015632

Identifier Type: NIH

Identifier Source: secondary_id

View Link

9P50AA015632

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIAAAOMA15632

Identifier Type: -

Identifier Source: org_study_id