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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


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
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