Behavioral Smoking Cessation Treatment - 1 - Full Text View

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00110825

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	Intervention
Tobacco Use Disorder	Behavioral: Tobacco Use Disorder

MedlinePlus related topics: Quitting Smoking Smoking

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Factorial Assignment, Efficacy Study
Official Title:	Behavioral Maintenance Treatment for Smoking Cessation

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

7 day point prevalence of cigarette abstinence

Secondary Outcome Measures:

Analog mood scales

Estimated Enrollment:

400

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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110825

Locations

United States, California
Stanford Stop Smoking Program
San Jose, California, United States, 95134

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Joel Killen, Ph.D.

Stanford University

More Information

Study ID Numbers:	NIDA-17441-1, R01-17441-1
Study First Received:	May 13, 2005
Last Updated:	May 23, 2008
ClinicalTrials.gov Identifier:	NCT00110825
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Smoking
Mental Disorders
Tobacco Use Disorder
Substance-Related Disorders
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on January 16, 2009