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

NCT00158158 | Completed Phase 2 DMC

• 3 other identifiers: NIDA-14538-2R01-14538-2DPMC
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Smoking Cessation; Tobacco Use Disorder

Keywords

smoking addiction

Outcome Measures

Primary Outcomes (2)

• Quit Rate; measured throughout study

  26 weeks

• Extent of reduction in smoking; measured at Week 6

  6, 12 and 26 weeks

Secondary Outcomes (2)

• 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

Study Arms (2)

1

PLACEBO COMPARATOR

Usual care

Drug: Usual Care

2

EXPERIMENTAL

Reduction in smoking

Other: Smoking Reduction

Interventions

Usual Care DRUG

If unable to quit at quit date, offered usual care to set another quit date.

Also known as: Nicoderm used for initial quit attempt.

1

Smoking Reduction OTHER

If unable to quit smoking, reduce smoking rate prior to quit date.

Also known as: Nicotine patch used for initial cessation and smoking reduction.

2

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

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

Condition Hierarchy (Ancestors)

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

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: September 1, 2005
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: January 10, 2017

Record last verified: 2016-10

Locations

US (1)