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

NCT ID: NCT00158171

Last Updated: 2017-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-04-30
• Study Completion Date: 2004-05-31

Brief 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.

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 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.

Conditions

Smoking Cessation; Tobacco Use Disorder

Study Design

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

Study Groups

1

Nicotine patch

Group Type: EXPERIMENTAL

Nicotine Replacement Therapies

Intervention Type: DRUG

Nicotine gum 2 \& 4 mg dependent on baseline smoking rate

2

Nicotine gum

Group Type: EXPERIMENTAL

Nicotine patch

Intervention Type: DRUG

21, 14 or 7 mg patch dependent on baseline smoking rate

3

Folic acid

Group Type: PLACEBO_COMPARATOR

Folic Acid

Intervention Type: DIETARY_SUPPLEMENT

400 mg

Interventions

Nicotine Replacement Therapies

Nicotine gum 2 \& 4 mg dependent on baseline smoking rate

Intervention Type: DRUG

Nicotine patch

21, 14 or 7 mg patch dependent on baseline smoking rate

Intervention Type: DRUG

Folic Acid

400 mg

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Nicorette; Nicoderm

Eligibility Criteria

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: lead

Responsible Party

UMN

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

R01-14538-1

Identifier Type: -

Identifier Source: secondary_id

DPMC

Identifier Type: -

Identifier Source: secondary_id

NIDA-14538-1

Identifier Type: -

Identifier Source: org_study_id