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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00158171
First Posted: September 12, 2005
Last Update Posted: January 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute on Drug Abuse (NIDA)
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00158171


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

Responsible Party: Dorothy Hatsukami, UMN
ClinicalTrials.gov Identifier: NCT00158171     History of Changes
Other Study ID Numbers: NIDA-14538-1
R01-14538-1
DPMC
First Submitted: September 8, 2005
First Posted: September 12, 2005
Last Update Posted: January 10, 2017
Last Verified: October 2016

Keywords provided by National Institute on Drug Abuse (NIDA):
smoking addiction

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