Nicotine Patch and Bupropion to Reduce Smoking Rates in Younger, Low-Income, and Minority Individuals

Summary

Nicotine addiction is a serious health problem in the United States; 46 million people smoke cigarettes, and 70% of those are trying to quit. The nicotine patch and bupropion, a medication used to reduce nicotine cravings, are two commonly used smoking cessation aids. Both have been shown to reduce smoking rates, however, the effectiveness of combining the two treatments has not been widely examined. This study will evaluate the effectiveness of the nicotine patch combined with bupropion at reducing smoking rates among younger, low-income, and minority individuals.

Conditions

• Tobacco Use Disorder

Interventions

DRUG

Nicotine Patch

After determining that it is appropriate to dispense study medication to a participant, the dosing regimen will be determined. Participants who report smoking more than 20 cigarettes each day will be initially placed on the 21 mg patch; participants who report smoking 10 - 19 cigarettes each day will be initially placed on the 14 mg patch; participants who report smoking 5 - 9 cigarettes will be initially placed on the 7 mg patch. If a participant is initially placed on the 21 mg patch, the following dosing schedule will occur: 21 mg patch for 4 weeks, 14 mg patch for 4 weeks, 7 mg patch for 2 weeks, and then off. If a participant is initially placed on the 14 mg patch, the following dosing schedule will occur: 14 mg patch for 6 weeks, 7 mg patch for 4 weeks, and then off. If a participant is initially placed on the 7 mg patch, the following dosing schedule will occur: 7 mg patch for 10 weeks, and then off.

DRUG

Sustained Release Bupropion

Participants will receive the sustained-release bupropion 150 mg tablet in the morning for four days. If this dose is well-tolerated, then the dose will be increased to a 150 mg tablet twice daily, with at least 8 hours between the two doses. The sustained-release bupropion medication will begin at the randomization visit (RV) which is approximately one week before the quit date. At the RV, the participant should be dispensed enough of the 150 mg tablets of the sustained-release bupropion or placebo to return for the first follow-up visit with instructions on use. Participants will be evaluated by telephone on their quit date approximately one week after the RV to assess safety. We will discontinue the sustained-release bupropion at the second follow-up visit, at which time participants will have received sustained-release bupropion for approximately 11 weeks.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• University of Tennessee

  lead OTHER

Principal Investigators

• Karen C. Johnson, MD, MPH · University of Tennessee

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2004-01-31

Primary Completion

2008-12-31

Completion

2008-12-31

Countries

• United States

Study Locations