Bupropion Treatment for Youth Smoking Cessation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00344695
Recruitment Status : Completed
First Posted : June 27, 2006
Last Update Posted : June 27, 2006
Information provided by:
University of Arizona

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.

Condition or disease Intervention/treatment Phase
Nicotine Dependence Drug: bupropion SR Phase 3

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Study Completion Date : April 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Quitting Smoking
U.S. FDA Resources

Primary Outcome Measures :
  1. Biochemically verified 7 day point prevalence abstinence from smoking.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   14 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00344695

United States, Arizona
University of Arizona
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
University of Arizona
Principal Investigator: Myra L. Muramoto, MD MPH University of Arizona

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00344695     History of Changes
Other Study ID Numbers: 3R01CA077081-04S1 ( U.S. NIH Grant/Contract )
First Posted: June 27, 2006    Key Record Dates
Last Update Posted: June 27, 2006
Last Verified: June 2006

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors