Bupropion Treatment for Youth Smoking Cessation - Tabular View

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Bupropion Treatment for Youth Smoking Cessation

This study has been completed.

Study NCT00344695. Last updated on June 23, 2006. Information provided by University of Arizona

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Bupropion Treatment for Youth Smoking Cessation

Official Title ^†

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

Biochemically verified 7 day point prevalence abstinence from smoking.

Secondary Outcome Measure ^†

Condition ^†

Nicotine Dependence

Intervention ^†

Drug: bupropion SR

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

Completion Date

April 2003

Eligibility 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.

Gender

Both

Ages

14 Years to 17 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00344695

Organization ID

3 R01 CA77081-04S1

Secondary IDs ^††

Study Sponsor ^†

University of Arizona

Collaborators ^††

Investigators ^†

Principal Investigator:

Myra L. Muramoto, MD MPH

University of Arizona

Information Provided By

University of Arizona

Verification Date

June 2006

First Received Date ^†

June 23, 2006

Last Updated Date

June 23, 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.