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

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00158171
First received: September 8, 2005
Last updated: June 27, 2008
Last verified: June 2008

September 8, 2005
June 27, 2008
April 2002
May 2004   (final data collection date for primary outcome measure)
Reduction in tobacco toxicant exposure [ Time Frame: Weeks 2, 5 and 17 ] [ Designated as safety issue: No ]
Tobacco Use Status; measured at Weeks 5 & 17
Complete list of historical versions of study NCT00158171 on ClinicalTrials.gov Archive Site
  • Motivation and self-efficacy to quit; measured at Weeks 5 and 17 [ Time Frame: Weeks 5 and 17 ] [ Designated as safety issue: No ]
  • Reduction in cigarettes per day [ Time Frame: Weeks 5 and 17 ] [ Designated as safety issue: No ]
  • Smoking cessation [ Time Frame: Weeks 5 and 17 ] [ Designated as safety issue: No ]
  • Motivation and self-efficacy to quit; measured at Weeks 5 and 17
  • Toxic cigarette exposure; measured at Weeks 5 and 17
Not Provided
Not Provided
 
Effectiveness of Various Smoking Cessation Therapies in Reducing Smoking in Adolescents - 1
Interventions for Tobacco Dependent Adolescents

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Smoking Cessation
  • Tobacco Use Disorder
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
128
May 2004
May 2004   (final data collection date for primary outcome measure)

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
Both
13 Years to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00158171
NIDA-14538-1, R01-14538-1, DPMC
Yes
Dorothy Hatsukami, UMN
National Institute on Drug Abuse (NIDA)
Not Provided
Principal Investigator: Dorothy Hatsukami, Ph.D. University of Minnesota - Clinical and Translational Science Institute
National Institute on Drug Abuse (NIDA)
June 2008

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