Smoking Cessation Medications: Efficacy, Mechanisms and Algorithms

University of Wisconsin (UW)

Status and phase: Completed; Phase 4

Conditions: Nicotine Dependence

Treatments: Drug: bupropion; Drug: nicotine patch + nicotine lozenge; Drug: nicotine patch; Drug: bupropion + lozenge; Drug: nicotine lozenge; Drug: placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00332644

P50DA19706-1

P50DA019706 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The proposed work will advance the understanding and effectiveness of tobacco dependence treatment and result in more smokers quitting successfully.

Full description

This research study will last for three years. The first year involves a comparison of smoking cessation medications (bupropion, nicotine patch, and nicotine lozenge), including medications used in combination. The results of this study may allow researchers and clinicians to decide which medications are best for helping people to quit smoking as well as what treatments work best for different people. In addition, the first year of this study may help to clarify how these medications work.The purpose of the second and third years of this research study will be to get long-term results on the physical health, mental health, lifestyle factors, and the overall quality of life of people attempting to quit smoking. The results of this study may help researchers and clinicians better understand the health improvements that come from quitting or not quitting smoking.

Enrollment: 1,504 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Smoke at least 10 cigarettes per day for the previous 6 months - Expired CO > 9 ppm - Motivated to quit smoking - Able to read and write English - Willing to complete required study assessments

Exclusion criteria

• Uncontrolled hypertension (systolic >180mm Hg or diastolic >110mm Hg) - History of bipolar disorder or psychosis - Myocardial infarction or other serious cardiac problem in the previous 4 weeks - History of diagnosed anorexia and/or bulimia - Diagnosis of Alcohol Dependence in the previous 6 months by participant self-report or drinking 6 or more drinks on six or more days a week - History of seizure and/or serious head injury involving loss of consciousness - Use of contraindicated medications (MAO inhibitors, bupropion, lithium, anticonvulsants, antipsychotics) - Currently pregnant or breast-feeding - Unwilling to use effective contraception during the treatment phase - More than one participant from the same household - Allergic reactions to 3 or more classes of drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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1,504 participants in 6 patient groups, including a placebo group

1

Experimental group

Description:

nicotine patch alone treatment

Treatment:

Drug: nicotine patch

2

Experimental group

Description:

nicotine lozenge alone treatment

Treatment:

Drug: nicotine lozenge

3

Experimental group

Description:

nicotine patch + lozenge combination treatment

Treatment:

Drug: nicotine patch + nicotine lozenge

4

Experimental group

Description:

bupropion alone treatment

Treatment:

Drug: bupropion

5

Experimental group

Description:

bupropion + nicotine lozenge combination treatment

Treatment:

Drug: bupropion + lozenge

6

Placebo Comparator group

Description:

placebo control (no active medication) treatment

Treatment:

Drug: placebo