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

NCT ID: NCT00158158

Last Updated: 2017-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2007-09-30

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.

Conditions

Smoking Cessation; Tobacco Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Usual care

Group Type: PLACEBO_COMPARATOR

Usual Care

Intervention Type: DRUG

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

2

Reduction in smoking

Group Type: EXPERIMENTAL

Smoking Reduction

Intervention Type: OTHER

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

Interventions

Usual Care

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

Intervention Type: DRUG

Smoking Reduction

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

Intervention Type: OTHER

Other Intervention Names

Nicoderm used for initial quit attempt.; Nicotine patch used for initial cessation and smoking reduction.

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: lead

Responsible Party

University of Minnesota

Principal Investigators

Dorothy Hatsukami, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

R01-14538-2

Identifier Type: -

Identifier Source: secondary_id

DPMC

Identifier Type: -

Identifier Source: secondary_id

NIDA-14538-2

Identifier Type: -

Identifier Source: org_study_id