Risk Perception Among Quitting Smokers

NCT00384696 | Unknown FDA Drug

• 2 other identifiers: 2004-08061 K01 CD000193-01
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this behavioral research study is to put together and study a treatment for nicotine dependence that looks at how participant's thoughts and feelings about smoking may be related to how successfully they quit smoking.

Conditions

Smoking

Keywords

Risk Perception; Smoking Cessation; Nicotine Replacement Therapy; Questionnaire; Nicotine

Outcome Measures

Primary Outcomes (1)

• Risk Perceptions Over Time Among Smokers and Non Smokers

  Primary hypothesis is that abstainers will show higher risk perceptions than relapsers.

  4 weeks

Study Arms (1)

Smoking Cessation

Treatment to help quit smoking, including written self-help materials, counseling, and 4 week supply of nicotine patch plus 5 MD Anderson Visits.

Drug: Nicotine Replacement Therapy; Behavioral: Questionnaire

Interventions

Nicotine Replacement Therapy DRUG

4 Weeks of nicotine patch. Patch therapy for participants who smoke \>10 cigarettes/day consists of 2 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day consists of 2 weeks of 14 mg patches and 2 weeks of 7 mg patches.

Smoking Cessation

Questionnaire BEHAVIORAL

Survey taking 1 and 1/2 hours at each study visit.

Smoking Cessation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Current smoker, age 18 to 65 years, with history of 5 cigarettes/day for last year wishing to quit

You may qualify if:

• Age 18 to 65 years.
• Current smoker with a history of at least 5 cigarettes/day for the last year
• Motivated to quit within the next week.
• Home address and a functioning home telephone number.
• Can speak, read, and write in English at a sixth-grade literacy level.

You may not qualify if:

• Contraindication for nicotine patch use.
• Active substance abuse or dependence.
• Regular use of tobacco products other than cigarettes (cigars, pipes, smokeless).
• Use of bupropion or nicotine products other than the nicotine patches supplied by the study.
• Pregnancy or lactation.
• Another household member enrolled in the study.
• Participation in a smoking cessation program or study during the past 90 days.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Smoking; Smoking Cessation

Interventions

Nicotine Replacement Therapy; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Lorna H. McNeill, PHD, MPH

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2006
• First Posted: October 6, 2006
• Study Start: February 10, 2006
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: May 24, 2019

Record last verified: 2019-05

Locations

US (1)