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

Smoking Cessation Clinical Trial

Official title:

Interventions for Tobacco Dependent Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00158158
• Other study ID #: NIDA-14538-2
• Secondary ID: R01-14538-2DPMC
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 8, 2005
• Last updated: January 9, 2017
• Start date: September 2005
• Est. completion date: September 2007

Study information

• Verified date: October 2016
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 19 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation
• Tobacco Use Disorder

Intervention

Drug:
• Usual Care
If unable to quit at quit date, offered usual care to set another quit date.

Other:
• Smoking Reduction
If unable to quit smoking, reduce smoking rate prior to quit date.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quit Rate; measured throughout study		26 weeks	No
Primary	Extent of reduction in smoking; measured at Week 6		6, 12 and 26 weeks	No
Secondary	Degree of motivation to quit; measured at Week 6		6, 12 and 26 weeks	No
Secondary	Extent of exposure to cigarette toxicity; measured throughout study		6, 12 and 26 weeks	No