Behavioral Smoking Cessation Treatment - 1

Not Applicable

Completed

• Conditions: Tobacco Use Disorder

• Registration Number: NCT00110825
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2005-05-13
• Study First Submitted QC: 2005-05-13
• Study First Posted: 2005-05-16
• Primary Completion: 2006-03
• Status Verified: 2009-06
• Study Completion: 2009-06
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 304

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
• 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 bupropion or NRT
• Previous failed quit attempt using NRT and bupropion in combination

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
7 day point prevalence of cigarette abstinence	8 weeks, 20 weeks, 52 weeks

Secondary Outcome Measures

Name	Time	Method
Analog mood scales	8 weeks, 20 weeks, 52 weeks

Trial Locations

Locations (1)

Stanford Stop Smoking Program; 🇺🇸 San Jose, California, United States