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Behavioral Smoking Cessation Treatment - 1

Primary Purpose

Tobacco Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavior Therapy
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Use Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Stanford Stop Smoking Program

Outcomes

Primary Outcome Measures

7 day point prevalence of cigarette abstinence

Secondary Outcome Measures

Analog mood scales

Full Information

First Posted
May 13, 2005
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00110825
Brief Title
Behavioral Smoking Cessation Treatment - 1
Official Title
Behavioral Maintenance Treatment for Smoking Cessation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
304 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavior Therapy
Intervention Description
extended treatment with cognitive behavior therapy
Primary Outcome Measure Information:
Title
7 day point prevalence of cigarette abstinence
Time Frame
8 weeks, 20 weeks, 52 weeks
Secondary Outcome Measure Information:
Title
Analog mood scales
Time Frame
8 weeks, 20 weeks, 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Killen, Ph.D.
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Stop Smoking Program
City
San Jose
State/Province
California
ZIP/Postal Code
95134
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18855829
Citation
Killen JD, Fortmann SP, Schatzberg AF, Arredondo C, Murphy G, Hayward C, Celio M, Cromp D, Fong D, Pandurangi M. Extended cognitive behavior therapy for cigarette smoking cessation. Addiction. 2008 Aug;103(8):1381-90. doi: 10.1111/j.1360-0443.2008.02273.x.
Results Reference
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Behavioral Smoking Cessation Treatment - 1

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