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

Interventions for Tobacco Dependent Adolescents

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 Overview

• Status: Completed
• Conditions: Smoking Cessation; Tobacco Use Disorder
• Intervention / Treatment: Drug: Usual Care; Other: Smoking Reduction

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 1; Usual care	Drug: Usual Care; If unable to quit at quit date, offered usual care to set another quit date.; Other Names: Nicoderm used for initial quit attempt.
Experimental: 2; Reduction in smoking	Other: Smoking Reduction; If unable to quit smoking, reduce smoking rate prior to quit date.; Other Names: Nicotine patch used for initial cessation and smoking reduction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Quit Rate; measured throughout study	26 weeks
Extent of reduction in smoking; measured at Week 6	6, 12 and 26 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Degree of motivation to quit; measured at Week 6	6, 12 and 26 weeks
Extent of exposure to cigarette toxicity; measured throughout study	6, 12 and 26 weeks

Collaborators and Investigators

• Sponsor: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Actual): September 1, 2007
• Study Completion (Actual): September 1, 2007

Study Registration Dates

• First Submitted: September 8, 2005
• First Submitted That Met QC Criteria: September 8, 2005
• First Posted (Estimate): September 12, 2005

Study Record Updates

• Last Update Posted (Estimate): January 10, 2017
• Last Update Submitted That Met QC Criteria: January 9, 2017
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: smoking addiction
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: NIDA-14538-2; DPMC (Other Identifier: NIDA); R01-14538-2