Bupropion Treatment for Youth Smoking Cessation

This study has been completed.
Sponsor:
Information provided by:
University of Arizona
ClinicalTrials.gov Identifier:
NCT00344695
First received: June 23, 2006
Last updated: NA
Last verified: June 2006
History: No changes posted
  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:


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
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, see Learn About Clinical Studies.

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):
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 July 26, 2014