Nicotine Gum |
Nicorette; Nicotine polacrilex |
Clinical Trial: Smoking Cessation Treatment - 1
This study is currently recruiting patients.
Purpose
Our primary goal is to examine the effectiveness of a multi-factor maintenance treatment strategy in promoting longer-term smoking abstinence. We will also conduct secondary analyses of mediators and moderators of treatment response.
| Condition | Treatment or Intervention |
|---|---|
| Behavior Therapy Bupropion Tobacco Use Disorder nicotine transdermal system | Behavior: Tobacco Use Disorder |
MedlinePlus related topics: Smoking
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Placebo Control, Factorial Assignment, Efficacy Study
Official Title: Behavioral Maintenance Treatment for Smoking Cessation
Secondary Outcomes: Analog mood scales
Expected Total Enrollment: 400
400 adult smokers will be randomized. Our primary goal is to examine the effectiveness of a multi-factor maintenance treatment strategy in promoting longer-term smoking abstinence. All smokers will receive the same "Acute Phase Treatment" that combines nicotine patch, bupropion and intensive self-regulatory skills training. Nicotine patches will be provided for 8 weeks and bupropion and skills training will be provided for of 9 weeks. Participants will then enter a "Maintenance Treatment Phase" during which half (n=200) will receive three individualized relapse prevention training sessions spread over a 12 week period. They will also receive 12 weeks of self-administered RPT administered via written treatment modules. Finally, telephone counseling will be provided in conjunction with an Interactive Voice Response system (IVR) that will allow early detection of smoking "slips" and rapid response by treatment staff. The other half (n=200) will be assigned to a control condition that consists of three counselor-led sessions of "supportive therapy" spread over a 12 week period. P
Eligibility
Ages Eligible for Study: 18 Years - 65 Years, Genders Eligible for Study: Both
Accepts Healthy Volunteers
Criteria
Inclusion Criteria:
- Healthy adult cigarette smokers smoking at least 10 cigarettes per day
Exclusion Criteria:
- Currently pregnant
- Currently breastfeeding
- Currently diagnosed with a seizure disorder, major depression, liver disease, kidney disease, congestive heart failure or diabetes mellitus
- History of a seizure, seizure disorder, significant head trauma or central nervous system tumor
- Family history of seizures
- Currently using intravenous drugs
- Currently using any drugs (marijuana, alcohol, cocaine, opiates, stimulants, etc.) on a daily basis
- Currently using any over-the-counter stimulants and anorectics (diet pills)
- Currently on bupropion (Wellbutrin, Wellbutrin SR) or other antidepressants, monoamine oxidase inhibitors, antipsychotics, benzodiazepines, theophylline, systemic steroids or levodopa
- Currently on NRT or bupropion (Zyban)
- Current or past diagnosis of anorexia nervosa or bulimia nervosa
Previous allergic response to buproprion or NRT
- Previous failed quit attempt using NRT and bupropion in combination
Location and Contact Information
California
Stanford Stop Smoking Program, San Jose, California, 95134, United States; Recruiting
Joel Killen, Ph.D., Principal Investigator, Stanford University
More Information
Record last reviewed: May 2005
Last Updated: May 13, 2005
Record first received: May 13, 2005
ClinicalTrials.gov Identifier: NCT00110825
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-05-17
Source: ClinicalTrials.gov
Cache Date: May 18, 2005
Resources
- Nicorette (Drug Digest)
- Nicotine Gum (Drug Digest)

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