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Effectiveness of Various Smoking Cessation Therapies in Reducing Smoking in Adolescents - 1

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ClinicalTrials.gov Identifier: NCT00158171
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : January 10, 2017
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)

Tracking Information
First Submitted Date  ICMJE September 8, 2005
First Posted Date  ICMJE September 12, 2005
Last Update Posted Date January 10, 2017
Study Start Date  ICMJE April 2002
Actual Primary Completion Date May 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2008)
Reduction in tobacco toxicant exposure [ Time Frame: Weeks 2, 5 and 17 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 8, 2005)
Tobacco Use Status; measured at Weeks 5 & 17
Change History Complete list of historical versions of study NCT00158171 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2008)
  • Motivation and self-efficacy to quit; measured at Weeks 5 and 17 [ Time Frame: Weeks 5 and 17 ]
  • Reduction in cigarettes per day [ Time Frame: Weeks 5 and 17 ]
  • Smoking cessation [ Time Frame: Weeks 5 and 17 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2005)
  • Motivation and self-efficacy to quit; measured at Weeks 5 and 17
  • Toxic cigarette exposure; measured at Weeks 5 and 17
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Various Smoking Cessation Therapies in Reducing Smoking in Adolescents - 1
Official Title  ICMJE Interventions for Tobacco Dependent Adolescents
Brief Summary Currently one in five high school students smokes. Smoking can harm adolescents well before they reach adulthood by causing a number of immediate, sometimes irreversible, health risks and problems. This study will compare the effectiveness of treatment with bupropion, a nicotine patch, or nicotine gum in supporting the reduction of smoking in adolescent smokers.
Detailed Description

Among adolescents, the short-term health effects of smoking include damage to the respiratory system, addiction to nicotine, and the associated risk of other drug use. Adolescents are at greater risk for long-term health problems because most young people who smoke regularly continue to smoke throughout adulthood. This study will compare the effectiveness of treatment with bupropion, a nicotine patch, or nicotine gum in supporting the reduction of smoking in adolescent smokers. The study will also assess whether reduction of smoking leads to continued involvement in treatment, less toxic cigarette exposure, and improved motivation to quit.

This open-label study will last a total of 6 weeks. Baseline measurements will be taken twice a week at study visits for the first two weeks to assess vital signs and smoking behavior. Participants will aslo use a computerized device outside of study visits to monitor their own smoking habits. At Week 3, participants will be randomly assigned to receive bupropion, a nicotine patch, nicotine gum, or placebo. Participants will be asked to limit the frequency of their smoking to 75% of what it was during baseline. During Weeks 4, 5, and 6, participants will be expected to reduce smoking behavior to 50% of what it was at baseline. Customized doses of nicotine patches and nicotine gum, relative to the amount of cigarettes a participant smoked during baseline, will be dispensed weekly. Participants receiving bupropion or placebo will receive medication at each study visit and will take one pill daily. During treatment, study visits will occur once weekly. At each study visit, all participants will receive a 10- to 15-minute standardized behavioral therapy session aimed at supporting smoking reduction. Smoking habits and vital signs will be assessed and the effects of the treatments will be determined. There will be one follow-up visit 3 months post-intervention, at which time smoking status will be assessed.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Smoking Cessation
  • Tobacco Use Disorder
Intervention  ICMJE
  • Drug: Nicotine Replacement Therapies
    Nicotine gum 2 & 4 mg dependent on baseline smoking rate
    Other Name: Nicorette
  • Drug: Nicotine patch
    21, 14 or 7 mg patch dependent on baseline smoking rate
    Other Name: Nicoderm
  • Dietary Supplement: Folic Acid
    400 mg
Study Arms  ICMJE
  • Experimental: 1
    Nicotine patch
    Intervention: Drug: Nicotine Replacement Therapies
  • Experimental: 2
    Nicotine gum
    Intervention: Drug: Nicotine patch
  • Placebo Comparator: 3
    Folic acid
    Intervention: Dietary Supplement: Folic Acid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 27, 2008)
128
Original Enrollment  ICMJE
 (submitted: September 8, 2005)
0
Actual Study Completion Date  ICMJE May 2004
Actual Primary Completion Date May 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • At least 6 months of daily cigarette smoking
  • No use of other tobacco products
  • Motivated to reduce or quit smoking
  • Not currently using medications to quit smoking
  • Agree to use an effective form of contraception throughout the study

Exclusion Criteria:

  • People for whom use of nicotine replacement therapy or bupropion is medically inadvisable
  • History of alcohol or drug abuse within 6 months of enrollment
  • History of emotional problems (as assessed by the Adolescent Symptoms Inventory) within 6 months prior to enrollment
  • Currently on an unstable dose of psychoactive medications
  • Currently taking medications that may react with one of the treatment medications
  • Pregnant
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00158171
Other Study ID Numbers  ICMJE NIDA-14538-1
R01-14538-1
DPMC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dorothy Hatsukami, UMN
Study Sponsor  ICMJE National Institute on Drug Abuse (NIDA)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dorothy Hatsukami, Ph.D. University of Minnesota - Clinical and Translational Science Institute
PRS Account National Institute on Drug Abuse (NIDA)
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP