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 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Quitting Smoking Smoking Smoking and Youth

Drug Information available for: Bupropion hydrochloride Bupropion

U.S. FDA Resources

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

No publications provided by University of Arizona

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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

Additional relevant MeSH terms:

Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents

Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013