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OpenTrials
Completed

NCT Number: NCT00158158

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

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

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Key information

Age range

13 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Usual Care

Drug

If unable to quit at quit date, offered usual care to set another quit date.

Other names: Nicoderm used for initial quit attempt.

Smoking Reduction

Other

If unable to quit smoking, reduce smoking rate prior to quit date.

Other names: Nicotine patch used for initial cessation and smoking reduction.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Registry information

Official study title

Interventions for Tobacco Dependent Adolescents

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Sep 12, 2005
Registry last updated
Jan 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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