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

NCT00158171 | Completed Phase 2 DMC

• 3 other identifiers: NIDA-14538-1R01-14538-1DPMC
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation; Tobacco Use Disorder

Keywords

smoking addiction

Outcome Measures

Primary Outcomes (1)

• Reduction in tobacco toxicant exposure

  Weeks 2, 5 and 17

Secondary Outcomes (3)

• Motivation and self-efficacy to quit; measured at Weeks 5 and 17

  Weeks 5 and 17

• Reduction in cigarettes per day

  Weeks 5 and 17

• Smoking cessation

  Weeks 5 and 17

Study Arms (3)

1

EXPERIMENTAL

Nicotine patch

Drug: Nicotine Replacement Therapies

2

EXPERIMENTAL

Nicotine gum

Drug: Nicotine patch

3

PLACEBO COMPARATOR

Folic acid

Dietary Supplement: Folic Acid

Interventions

Nicotine Replacement Therapies DRUG

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

Also known as: Nicorette

1

Nicotine patch DRUG

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

Also known as: Nicoderm

2

Folic Acid DIETARY_SUPPLEMENT

400 mg

3

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Tobacco Use Disorder

Interventions

Nicotine Replacement Therapy; Nicotine Chewing Gum; Tobacco Use Cessation Devices; Nicotine; Folic Acid

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Chewing Gum; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Dorothy Hatsukami, Ph.D.

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: April 1, 2002
• Primary Completion: May 1, 2004
• Study Completion: May 1, 2004
• Last Updated: January 10, 2017

Record last verified: 2016-10

Locations

US (1)