Bupropion Treatment for Youth Smoking Cessation - Full Text View

Purpose

The purpose of this study is to 1) evaluate the safety and efficacy of two doses of bupropion SR (150mg/day and 300mg/day) when compared to placebo, as an aid to smoking cessation in adolescents and 2) to examine which factors, such as medication adherence, nicotine dependence, and motivation to quit, affect treatment outcome.

Condition	Intervention	Phase
Nicotine Dependence	Drug: bupropion SR	Phase III

MedlinePlus related topics:

Smoking Smoking Cessation Smoking and Youth

ChemIDplus related topics:

Bupropion hydrochloride Bupropion

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by University of Arizona:

Primary Outcome Measures:

Biochemically verified 7 day point prevalence abstinence from smoking.

Estimated Study Completion Date:

April 2003

Eligibility

Ages Eligible for Study:	14 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

14 to 17 years of age
Smoked at least 6 cigarettes per day
Exhaled CO greater than or equal to 10 ppm
Made at least two previous quit attempts
Weighed at least 90 pounds
Able to read English at least the 6th grade level
Motivated to quit smoking as evidenced by willingness to commit to study protocol requirements for the duration of the study
provided active parental consent and youth assent

Exclusion Criteria:

Current use of tobacco products other than cigarettes, unless willing to abstain from these products for the study duration
Current use of other treatments for smoking cessation
History or current diagnosis of panic disorder, psychosis, bipolar disorder, or eating disorder
History of abuse or dependence on alcohol or other recreational or prescription drugs in the three months preceding the study
Current evidence of clinical depression or Attention Deficit/Hyperactivity Disorder
Use of any psychoactive drug and/or any type of antidepressant with in four weeks of the treatment phase of the study
Predisposition to seizure or tic disorders or a personal history of a seizure disorder, family history of seizure disorders, or treatment with medication or therapies that increase the risk of seizures
Significant history of or current clinical evidence of cardiovascular disease
(Females)Pregnancy (urine pregnancy test), lactation or, if sexually active, unwillingness to use a medically acceptable form of contraception for the duration of the study
Only one member of a household was allowed to participate in the study concurrently.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00344695

Locations


United States, Arizona
	University of Arizona
	Tucson, Arizona, United States, 85724

Sponsors and Collaborators

University of Arizona

Investigators


Principal Investigator:	Myra L. Muramoto, MD MPH	University of Arizona

More Information

Publications indexed to this study:

Muramoto ML, Leischow SJ, Sherrill D, Matthews E, Strayer LJ. Randomized, double-blind, placebo-controlled trial of 2 dosages of sustained-release bupropion for adolescent smoking cessation. Arch Pediatr Adolesc Med. 2007 Nov;161(11):1068-74.

Study ID Numbers:	3 R01 CA77081-04S1
First Received:	June 23, 2006
Last Updated:	June 23, 2006
ClinicalTrials.gov Identifier:	NCT00344695
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Smoking

Dopamine

Tobacco Use Disorder

Bupropion

Substance-Related Disorders

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors

Neurotransmitter Agents

Neurotransmitter Uptake Inhibitors

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Psychotropic Drugs

Disorders of Environmental Origin

Pharmacologic Actions

Mental Disorders

Therapeutic Uses

Dopamine Agents

Antidepressive Agents, Second-Generation

Central Nervous System Agents

Antidepressive Agents

ClinicalTrials.gov processed this record on July 03, 2008

Sponsored by:	University of Arizona
Information provided by:	University of Arizona
ClinicalTrials.gov Identifier:	NCT00344695