Clinical trial NCT00158158: Effectiveness of Reducing Smoking in Facilitating Smoking Cessation in Adolescents - 2
Official title: Interventions for Tobacco Dependent Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Smoking Cessation
Tobacco Use Disorder
Keywords: smoking addiction
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2005-09-12
Enrollment: 200
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Quit Rate; measured throughout study
timeFrame: 26 weeks
measure: Extent of reduction in smoking; measured at Week 6
timeFrame: 6, 12 and 26 weeks
Secondary outcomes:
measure: Degree of motivation to quit; measured at Week 6
timeFrame: 6, 12 and 26 weeks
measure: Extent of exposure to cigarette toxicity; measured throughout study
timeFrame: 6, 12 and 26 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Dorothy Hatsukami, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: