search
Back to results

Bupropion Treatment for Youth Smoking Cessation

Primary Purpose

Nicotine Dependence

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
bupropion SR
Sponsored by
University of Arizona
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nicotine Dependence

Eligibility Criteria

14 Years - 17 Years (Child)All SexesAccepts 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.

Sites / Locations

  • University of Arizona

Outcomes

Primary Outcome Measures

Biochemically verified 7 day point prevalence abstinence from smoking.

Secondary Outcome Measures

Full Information

First Posted
June 23, 2006
Last Updated
June 23, 2006
Sponsor
University of Arizona
search

1. Study Identification

Unique Protocol Identification Number
NCT00344695
Brief Title
Bupropion Treatment for Youth Smoking Cessation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2006
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Arizona

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
bupropion SR
Primary Outcome Measure Information:
Title
Biochemically verified 7 day point prevalence abstinence from smoking.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myra L. Muramoto, MD MPH
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17984409
Citation
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.
Results Reference
derived

Learn more about this trial

Bupropion Treatment for Youth Smoking Cessation

We'll reach out to this number within 24 hrs