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

Primary Purpose

Smoking Cessation, Tobacco Use Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Usual Care
Smoking Reduction
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking Cessation focused on measuring smoking addiction

Eligibility Criteria

13 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

1

2

Arm Description

Usual care

Reduction in smoking

Outcomes

Primary Outcome Measures

Quit Rate; measured throughout study
Extent of reduction in smoking; measured at Week 6

Secondary Outcome Measures

Degree of motivation to quit; measured at Week 6
Extent of exposure to cigarette toxicity; measured throughout study

Full Information

First Posted
September 8, 2005
Last Updated
January 9, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00158158
Brief Title
Effectiveness of Reducing Smoking in Facilitating Smoking Cessation in Adolescents - 2
Official Title
Interventions for Tobacco Dependent Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation, Tobacco Use Disorder
Keywords
smoking addiction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Usual care
Arm Title
2
Arm Type
Experimental
Arm Description
Reduction in smoking
Intervention Type
Drug
Intervention Name(s)
Usual Care
Other Intervention Name(s)
Nicoderm used for initial quit attempt.
Intervention Description
If unable to quit at quit date, offered usual care to set another quit date.
Intervention Type
Other
Intervention Name(s)
Smoking Reduction
Other Intervention Name(s)
Nicotine patch used for initial cessation and smoking reduction.
Intervention Description
If unable to quit smoking, reduce smoking rate prior to quit date.
Primary Outcome Measure Information:
Title
Quit Rate; measured throughout study
Time Frame
26 weeks
Title
Extent of reduction in smoking; measured at Week 6
Time Frame
6, 12 and 26 weeks
Secondary Outcome Measure Information:
Title
Degree of motivation to quit; measured at Week 6
Time Frame
6, 12 and 26 weeks
Title
Extent of exposure to cigarette toxicity; measured throughout study
Time Frame
6, 12 and 26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dorothy Hatsukami, Ph.D.
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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