Effectiveness of Various Smoking Cessation Therapies in Reducing Smoking in Adolescents - 1

Smoking Cessation Clinical Trial

Official title:

Interventions for Tobacco Dependent Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00158171
• Other study ID #: NIDA-14538-1
• Secondary ID: R01-14538-1DPMC
• Status: Completed
• Phase: Phase 2
• First received: September 8, 2005
• Last updated: January 9, 2017
• Start date: April 2002
• Est. completion date: May 2004

Study information

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

Clinical Trial Summary

Currently one in five high school students smokes. Smoking can harm adolescents well before they reach adulthood by causing a number of immediate, sometimes irreversible, health risks and problems. This study will compare the effectiveness of treatment with bupropion, a nicotine patch, or nicotine gum in supporting the reduction of smoking in adolescent smokers.

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 because most young people who smoke regularly continue to smoke throughout adulthood. This study will compare the effectiveness of treatment with bupropion, a nicotine patch, or nicotine gum in supporting the reduction of smoking in adolescent smokers. The study will also assess whether reduction of smoking leads to continued involvement in treatment, less toxic cigarette exposure, and improved motivation to quit.

This open-label study will last a total of 6 weeks. Baseline measurements will be taken twice a week at study visits for the first two weeks to assess vital signs and smoking behavior. Participants will aslo use a computerized device outside of study visits to monitor their own smoking habits. At Week 3, participants will be randomly assigned to receive bupropion, a nicotine patch, nicotine gum, or placebo. Participants will be asked to limit the frequency of their smoking to 75% of what it was during baseline. During Weeks 4, 5, and 6, participants will be expected to reduce smoking behavior to 50% of what it was at baseline. Customized doses of nicotine patches and nicotine gum, relative to the amount of cigarettes a participant smoked during baseline, will be dispensed weekly. Participants receiving bupropion or placebo will receive medication at each study visit and will take one pill daily. During treatment, study visits will occur once weekly. At each study visit, all participants will receive a 10- to 15-minute standardized behavioral therapy session aimed at supporting smoking reduction. Smoking habits and vital signs will be assessed and the effects of the treatments will be determined. There will be one follow-up visit 3 months post-intervention, at which time smoking status will be assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: May 2004
• Est. primary completion date: May 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

Inclusion Criteria:

• At least 6 months of daily cigarette smoking

• No use of other tobacco products

• Motivated to reduce or quit smoking

• Not currently using medications to quit smoking

• Agree to use an effective form of contraception throughout the study

Exclusion Criteria:

• People for whom use of nicotine replacement therapy or bupropion is medically inadvisable

• History of alcohol or drug abuse within 6 months of enrollment

• History of emotional problems (as assessed by the Adolescent Symptoms Inventory) within 6 months prior to enrollment

• Currently on an unstable dose of psychoactive medications

• Currently taking medications that may react with one of the treatment medications

• 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:
• Nicotine Replacement Therapies
Nicotine gum 2 & 4 mg dependent on baseline smoking rate
• Nicotine patch
21, 14 or 7 mg patch dependent on baseline smoking rate

Dietary Supplement:
• Folic Acid
400 mg

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	Reduction in tobacco toxicant exposure		Weeks 2, 5 and 17	No
Secondary	Motivation and self-efficacy to quit; measured at Weeks 5 and 17		Weeks 5 and 17	No
Secondary	Reduction in cigarettes per day		Weeks 5 and 17	No
Secondary	Smoking cessation		Weeks 5 and 17	No