Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: May 2004

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.

Intervention(s) in this Clinical Trial

• Drug: Nicotine Replacement Therapies
  • Nicotine gum 2 & 4 mg dependent on baseline smoking rate
• Drug: Nicotine patch
  • 21, 14 or 7 mg patch dependent on baseline smoking rate
• Dietary Supplement: Folic Acid
  • 400 mg

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Nicotine patch
• Experimental: 2
  • Nicotine gum
• Placebo Comparator: 3
  • Folic acid

Primary Measures

• Reduction in tobacco toxicant exposure
  • Time Frame: Weeks 2, 5 and 17
    Safety Issue?: No

Secondary Measures

• Motivation and self-efficacy to quit; measured at Weeks 5 and 17
  • Time Frame: Weeks 5 and 17
    Safety Issue?: No
• Reduction in cigarettes per day
  • Time Frame: Weeks 5 and 17
    Safety Issue?: No
• Smoking cessation
  • Time Frame: Weeks 5 and 17
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 13 Years

Maximum Age for this Clinical Trial: 18 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: National Institute on Drug Abuse (NIDA)

Overall Clinical Trial Officials and Contacts

Dorothy Hatsukami, Ph.D. Principal Investigator University of Minnesota  

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00158171

Study ID Number: NIDA-14538-1

ClinicalTrials.gov Identifier: NCT00158171

Health Authority: United States: Food and Drug Administration