Bupropion Treatment for Youth Smoking Cessation

NCT00344695 | Completed Phase 3

• 1 other identifier: 3R01CA077081-04S1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Nicotine Dependence

Outcome Measures

Primary Outcomes (1)

• Biochemically verified 7 day point prevalence abstinence from smoking.

Interventions

bupropion SR DRUG

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona

Tucson, Arizona, 85724, United States

Location

Related Publications (2)

• Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.

  PMID: 37230961 DERIVED

• Muramoto ML, Leischow SJ, Sherrill D, Matthews E, Strayer LJ. Randomized, double-blind, placebo-controlled trial of 2 dosages of sustained-release bupropion for adolescent smoking cessation. Arch Pediatr Adolesc Med. 2007 Nov;161(11):1068-74. doi: 10.1001/archpedi.161.11.1068.

  PMID: 17984409 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Myra L. Muramoto, MD MPH

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 23, 2006
• First Posted: June 27, 2006
• Study Completion: April 1, 2003
• Last Updated: June 27, 2006

Record last verified: 2006-06

Locations

US (1)