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

NCT00308763 | Completed DMC

• 3 other identifiers: 376R01HL066025R01HL066025-05
• Study Type: interventional
• Target: 594
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Smoking Cessation; Nicotine Dependence

Outcome Measures

Primary Outcomes (1)

• Smoking cessation rates (measured by self-report, saliva test, and exhaled carbon monoxide test)

  Measured at 1 year follow-up

Study Arms (3)

1

ACTIVE COMPARATOR

Nicotine patch plus placebo sustained-release bupropion

Drug: Nicotine Patch

2

ACTIVE COMPARATOR

Placebo nicotine patch plus sustained-release bupropion

Drug: Sustained Release Bupropion

3

ACTIVE COMPARATOR

Nicotine patch plus sustained-release bupropion

Drug: Nicotine Patch; Drug: Sustained Release Bupropion

Interventions

Nicotine Patch DRUG

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.

1; 3

Sustained Release Bupropion DRUG

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.

2; 3

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• In good health
• In a lower socioeconomic group, defined as below median income in the study county
• Smokes more than 5 cigarettes each day for at least 6 months prior to study entry, as determined by self-report

You may not qualify if:

• History of a seizure disorder, brain tumor, or severe head trauma
• History of substance abuse, including alcohol use in excess of 14 drinks a week
• History of anorexia or bulimia
• History of cerebral, coronary, or peripheral vascular disease
• History of serious heart arrhythmia
• Presence of an unstable psychiatric illness
• Current use of a psychotropic medication, including antidepressant medications
• History of peptic ulcer disease or currently taking an H2 blocker (e.g., cimetidine)
• History of kidney disease, defined as creatinine levels greater than 1.5 times the upper limit of normal
• History of liver disease, defined as serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic transaminase(SGPT) levels greater than twice the upper limit of normal
• History of uncontrolled hyperthyroidism or pheochromocytoma
• History of atopic or eczematous dermatitis
• Current use of a medication that cannot be discontinued and may interfere with study procedures or may increase the risk of side effects (e.g., nicotine gum, nicotine nasal spray, theophylline, systemic steroids, levodopa)
• History of an allergic reaction to the nicotine patch or bupropion
• History of diabetes treated with an oral agent or insulin

Sponsors & Collaborators

• University of Tennessee: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Tennessee Health Science Center / Department of Preventive Medicine

Memphis, Tennessee, 38105, United States

Location

Related Publications (1)

• Badrun F, Tolley B, Johnson KC. Smoking Cessation Interventions and Their Effects on Mood and Quit Pattern. In preparation 2014.

  RESULT

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking Cessation

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Karen C. Johnson, MD, MPH

  University of Tennessee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2006
• First Posted: March 30, 2006
• Study Start: January 1, 2004
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: May 21, 2014

Record last verified: 2014-05

Locations

US (1)