Smoking Cessation Medications: Efficacy, Mechanisms and Algorithms
This study has been completed.
Sponsor:
University of Wisconsin, Madison
Collaborator:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00332644
First received: June 1, 2006
Last updated: October 21, 2011
Last verified: October 2011
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Purpose
The proposed work will advance the understanding and effectiveness of tobacco dependence treatment and result in more smokers quitting successfully.
| Condition | Intervention | Phase |
|---|---|---|
|
Nicotine Dependence |
Drug: nicotine patch Drug: nicotine lozenge Drug: nicotine patch + nicotine lozenge Drug: bupropion Drug: bupropion + lozenge Drug: placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Pharmacotherapies: Efficacy, Mechanisms and Algorithms |
Resource links provided by NLM:
Drug Information available for:
Nicotine tartrate
Bupropion hydrochloride
Bupropion
Nicotine polacrilex
U.S. FDA Resources
Further study details as provided by University of Wisconsin, Madison:
Primary Outcome Measures:
- 7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed [ Time Frame: 6 months post quit date ] [ Designated as safety issue: No ]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).
| Enrollment: | 1504 |
| Study Start Date: | September 2004 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
nicotine patch alone treatment
|
Drug: nicotine patch
used according to FDA package label
|
|
Experimental: 2
nicotine lozenge alone treatment
|
Drug: nicotine lozenge
used according to FDA-approved package directions
|
|
Experimental: 3
nicotine patch + lozenge combination treatment
|
Drug: nicotine patch + nicotine lozenge
dosage of both according to FDA-approved dosing schedule
|
|
Experimental: 4
bupropion alone treatment
|
Drug: bupropion
dosage according to FDA-approved instructions
|
|
Experimental: 5
bupropion + nicotine lozenge combination treatment
|
Drug: bupropion + lozenge
dosage according to FDA approved standard instructions
|
|
Placebo Comparator: 6
placebo control (no active medication) treatment
|
Drug: placebo
dosage same as active drug conditions
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00332644
Locations
| United States, Wisconsin | |
| UW-CTRI Madison Research site | |
| Madison, Wisconsin, United States, 53711 | |
| UW-CTRI Milwaukee Research site | |
| Milwaukee, Wisconsin, United States, 53233 | |
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
| Principal Investigator: | Timothy B. Baker, PhD | University of Wisconsin, Madison |
More Information
Additional Information:
No publications provided by University of Wisconsin, Madison
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Wisconsin, Madison |
| ClinicalTrials.gov Identifier: | NCT00332644 History of Changes |
| Obsolete Identifiers: | NCT00109447 |
| Other Study ID Numbers: | P50DA19706-1, P50DA019706 |
| Study First Received: | June 1, 2006 |
| Results First Received: | October 21, 2011 |
| Last Updated: | October 21, 2011 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Tobacco Use Disorder Substance-Related Disorders Mental Disorders Nicotine Nicotine polacrilex Bupropion Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Nicotinic Agonists Cholinergic Agonists |
Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Uptake Inhibitors |
ClinicalTrials.gov processed this record on June 17, 2013