Effectiveness of Reducing Smoking in Facilitating Smoking Cessation in Adolescents - 2

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. Identifier: NCT00158158
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : January 10, 2017
Information provided by:
National Institute on Drug Abuse (NIDA)

Brief Summary:
Currently one in five high school students smoke. Smoking can harm adolescents well before they reach adulthood by causing a number of immediate, sometimes irreversible, health risks and problems. This study will examine whether reducing smoking will facilitate quitting smoking in adolescents who have unsuccessfully attempted to quit smoking

Condition or disease Intervention/treatment Phase
Smoking Cessation Tobacco Use Disorder Drug: Usual Care Other: Smoking Reduction Phase 2 Phase 3

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, including several types of cancer. This study will examine whether reducing smoking will facilitate smoking cessation in adolescents who have unsuccessfully attempted to quit smoking. The study will also assess whether reduction of smoking leads to continued involvement in treatment, less toxic cigarette exposure, and improved motivation and self-efficacy to quit.

Participants in this open-label study will undergo 2 weeks of baseline measurements, followed by 2 weeks of smoking cessation treatment. Treatment will involve a nicotine patch, for those who are eligible, and a standardized behavioral intervention aimed at supporting smoking cessation. Those who are ineligible to receive a nicotine patch will only receive the standardized behavioral intervention. Participants who quit smoking during the first phase of treatment will continue to receive the nicotine patches and/or the standardized behavioral intervention. Those who are still smoking after the first treatment will be randomly assigned to one of two conditions and will continue to use nicotine patches for 4 weeks. Group 1 will receive standardized behavioral therapy and will set a specific quit date. Group 2 will be encouraged to decrease smoking by 50% the first week and 75% the second week. During Week 3, participants will be encouraged to completely quit smoking. Study visits will occur weekly, at which time nicotine patches will be dispensed, standardized behavioral therapy will be provided, and standard physiological measurements will be taken. A urine sample will also be collected. Follow-up visits will be held 2 weeks, 3 weeks, and 6 months following completion of the study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interventions for Tobacco Dependent Adolescents
Study Start Date : September 2005
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: 1
Usual care
Drug: Usual Care
If unable to quit at quit date, offered usual care to set another quit date.
Other Name: Nicoderm used for initial quit attempt.

Experimental: 2
Reduction in smoking
Other: Smoking Reduction
If unable to quit smoking, reduce smoking rate prior to quit date.
Other Name: Nicotine patch used for initial cessation and smoking reduction.

Primary Outcome Measures :
  1. Quit Rate; measured throughout study [ Time Frame: 26 weeks ]
  2. Extent of reduction in smoking; measured at Week 6 [ Time Frame: 6, 12 and 26 weeks ]

Secondary Outcome Measures :
  1. Degree of motivation to quit; measured at Week 6 [ Time Frame: 6, 12 and 26 weeks ]
  2. Extent of exposure to cigarette toxicity; measured throughout study [ Time Frame: 6, 12 and 26 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Has smoked at least 5 cigarettes a day for at least 6 months
  • Does not regularly use other tobacco products
  • Motivated to quit smoking
  • Not currently using medications to quit smoking
  • Willing to use an effective form of contraception throughout the study

Exclusion Criteria:

  • Informed that nicotine replacement therapy is medically inadvisable
  • Diagnosed with a psychiatric disorder within 3 months prior to enrollment
  • Currently taking an unstable dose of psychoactive medications
  • Currently taking medications that may react with a nicotine patch
  • History of alcohol or drug abuse within 3 months prior to enrollment
  • Pregnant

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 identifier (NCT number): NCT00158158

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

Responsible Party: Dorothy Hatsukami, University of Minnesota Identifier: NCT00158158     History of Changes
Other Study ID Numbers: NIDA-14538-2
First Posted: September 12, 2005    Key Record Dates
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