Smoking Cessation Medications: Efficacy, Mechanisms and Algorithms

Nicotine Dependence Clinical Trial

Official title:

Pharmacotherapies: Efficacy, Mechanisms and Algorithms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00332644
• Other study ID #: P50DA19706-1
• Secondary ID: P50DA019706
• Status: Completed
• Phase: Phase 4
• First received: June 1, 2006
• Last updated: October 21, 2011
• Start date: September 2004
• Est. completion date: August 2010

Study information

• Verified date: October 2011
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Other known NCT identifiers

• NCT00109447

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1504
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nicotine Dependence

Intervention

Drug:
• nicotine patch
used according to FDA package label
• nicotine lozenge
used according to FDA-approved package directions
• nicotine patch + nicotine lozenge
dosage of both according to FDA-approved dosing schedule
• bupropion
dosage according to FDA-approved instructions
• bupropion + lozenge
dosage according to FDA approved standard instructions
• placebo
dosage same as active drug conditions

Locations

Country	Name	City	State
United States	UW-CTRI Madison Research site	Madison	Wisconsin
United States	UW-CTRI Milwaukee Research site	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed	Smoking status was assessed both as 7-day point-prevalence abstinence ("Have you smoked at all, even a puff, in the last 7 days?") and continuous abstinence (smoking at all since the target quit day), using a smoking calendar and the timeline follow-back method. All participants' self-reports of smoking status during study visits were confirmed by an expired carbon monoxide level of less than 10 ppm measured using a Micro-3 Smokerlyzer (Bedfont Scientific, Williamsburg, Virginia).	6 months post quit date	No

External Links

•   home page of agency performing the research