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
  Purpose

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.


Condition Intervention Phase
Smoking Cessation
Tobacco Use Disorder
Drug: Nicotine Replacement Therapies
Drug: Nicotine patch
Dietary Supplement: Folic Acid
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Interventions for Tobacco Dependent Adolescents

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Reduction in tobacco toxicant exposure [ Time Frame: Weeks 2, 5 and 17 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 128
Study Start Date: April 2002
Study Completion Date: May 2004
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Nicotine patch
Drug: Nicotine Replacement Therapies
Nicotine gum 2 & 4 mg dependent on baseline smoking rate
Other Name: Nicorette
Experimental: 2
Nicotine gum
Drug: Nicotine patch
21, 14 or 7 mg patch dependent on baseline smoking rate
Other Name: Nicoderm
Placebo Comparator: 3
Folic acid
Dietary Supplement: Folic Acid
400 mg

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.

  Eligibility

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00158171

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Investigators
Principal Investigator: Dorothy Hatsukami, Ph.D. University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: Dorothy Hatsukami, UMN
ClinicalTrials.gov Identifier: NCT00158171     History of Changes
Other Study ID Numbers: NIDA-14538-1, R01-14538-1, DPMC
Study First Received: September 8, 2005
Last Updated: June 27, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Folic Acid
Vitamin B Complex
Nicotine
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 27, 2014