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

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00158158
First received: September 8, 2005
Last updated: June 27, 2008
Last verified: June 2008
History of Changes
  Purpose

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 Intervention Phase
Smoking Cessation
Tobacco Use Disorder
 Drug: Usual Care
Other: Smoking Reduction
 Phase 2
Phase 3

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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Quit Rate; measured throughout study [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Extent of reduction in smoking; measured at Week 6 [ Time Frame: 6, 12 and 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Degree of motivation to quit; measured at Week 6 [ Time Frame: 6, 12 and 26 weeks ] [ Designated as safety issue: No ]
  • Extent of exposure to cigarette toxicity; measured throughout study [ Time Frame: 6, 12 and 26 weeks ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: September 2005
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   13 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00158158

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

No publications provided

Responsible Party: Dorothy Hatsukami, University of Minnesota
ClinicalTrials.gov Identifier: NCT00158158     History of Changes
Other Study ID Numbers: NIDA-14538-2, R01-14538-2, DPMC
Study First Received: September 8, 2005
Last Updated: June 27, 2008
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Additional relevant MeSH terms:
Smoking
Tobacco Use Disorder
Habits
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 18, 2013