Expired Study
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Minneapolis, Minnesota 55455


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


Study summary:

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.


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


Study is Available At:


Original ID:

NIDA-14538-2


NCT ID:

NCT00158158


Secondary ID:

R01-14538-2


Study Acronym:


Brief Title:

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


Official Title:

Interventions for Tobacco Dependent Adolescents


Overall Status:

Completed


Study Phase:

Phase 2/Phase 3


Genders:

Both


Minimum Age:

13 Years


Maximum Age:

19 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute on Drug Abuse (NIDA)


Oversight Authority:

  • United States: Federal Government
  • United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

200


Enrollment Type:

Actual


Overall Contact Information

Official Name:Dorothy Hatsukami, Ph.D.
Principal Investigator
University of Minnesota - Clinical and Translational Science Institute

Study Dates

Start Date:September 2005
Completion Date:September 2007
Completion Type:Actual
Primary Completion Date:September 2007
Primary Completion Type:Actual
Verification Date:October 2016
Last Changed Date:January 9, 2017
First Received Date:September 8, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Extent of exposure to cigarette toxicity; measured throughout study
Time Frame:6, 12 and 26 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Degree of motivation to quit; measured at Week 6
Time Frame:6, 12 and 26 weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Extent of reduction in smoking; measured at Week 6
Time Frame:6, 12 and 26 weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Quit Rate; measured throughout study
Time Frame:26 weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Usual Care
Description:If unable to quit at quit date, offered usual care to set another quit date.
Arm Name:1
Other Name:Nicoderm used for initial quit attempt.
Intervention Type:Other
Name:Smoking Reduction
Description:If unable to quit smoking, reduce smoking rate prior to quit date.
Arm Name:2
Other Name:Nicotine patch used for initial cessation and smok

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:1
Description:Usual care
Study Arm Type:Experimental
Arm Name:2
Description:Reduction in smoking

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute on Drug Abuse (NIDA)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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