Bupropion Treatment for Youth Smoking Cessation

University of Arizona

Status and phase

Completed

Phase 3

Conditions

Nicotine Dependence

Treatments

Drug: bupropion SR

Study type

Interventional

Funder types

Other

Identifiers

NCT00344695

3R01CA077081-04S1

Details and patient eligibility

About

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.

Sex

All

Ages

14 to 17 years old

Volunteers

Accepts Healthy Volunteers

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.