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

January 9, 2017 updated by: National Institute on Drug Abuse (NIDA)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

128

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Nicotine patch
Drug: Nicotine Replacement Therapies
Nicotine gum 2 & 4 mg dependent on baseline smoking rate
Other Names:
  • Nicorette
Experimental: 2
Nicotine gum
Drug: Nicotine patch
21, 14 or 7 mg patch dependent on baseline smoking rate
Other Names:
  • Nicoderm
Placebo Comparator: 3
Folic acid
Dietary supplement: Folic Acid
400 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in tobacco toxicant exposure
Time Frame: Weeks 2, 5 and 17
Weeks 2, 5 and 17

Secondary Outcome Measures

Outcome Measure
Time Frame
Motivation and self-efficacy to quit; measured at Weeks 5 and 17
Time Frame: Weeks 5 and 17
Weeks 5 and 17
Reduction in cigarettes per day
Time Frame: Weeks 5 and 17
Weeks 5 and 17
Smoking cessation
Time Frame: Weeks 5 and 17
Weeks 5 and 17

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Drug Abuse (NIDA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Primary Completion (Actual)

May 1, 2004

Study Completion (Actual)

May 1, 2004

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

January 10, 2017

Last Update Submitted That Met QC Criteria

January 9, 2017

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-14538-1
  • R01-14538-1
  • DPMC (Other Identifier: NIDA)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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