Status:
COMPLETED
Bupropion Treatment for Youth Smoking Cessation
Lead Sponsor:
University of Arizona
Conditions:
Nicotine Dependence
Eligibility:
All Genders
14-17 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
April 1 2003
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00344695
End Date
April 1 2003
Last Update
June 27 2006
Active Locations (1)
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1
University of Arizona
Tucson, Arizona, United States, 85724