Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00384696
Other study ID # 2004-0806
Secondary ID 1 K01 CD000193-0
Status Active, not recruiting
Phase
First received
Last updated
Start date February 10, 2006
Est. completion date December 31, 2020

Study information

Verified date May 2019
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

If patient agrees to participate, they will receive free treatment to help them quit smoking, including written self-help materials, counseling, and a supply of the nicotine patch for 4 weeks. Participant will visit M. D. Anderson 5 times during this study; once for an orientation/intake visit, and then for 4 more study visits.

At the first (orientation) visit, participant will be asked about their feelings and moods, as well as their smoking status. Participant will fill out questionnaires on a computer and complete a breath test. The questionnaires will be about mood, stress, and smoking-related issues, and should take about 1 hour and 30 minutes to complete. To complete the breath test, participant will blow into a tube that's attached to a machine about the size of a pocket computer. The breath test is used to estimate the amount of tobacco smoke that participant inhales. Participant will also complete two computer-based tasks. Women who are pregnant should not take part in this study.

In addition, participant will receive a palmtop personal computer and be trained in how to use it. Participant will carry this small computer with them from the time of their first visit until their last study visit. Participant will use the computer to answer questions about their mood, stress, and smoking-related issues. Participant will be asked to fill out some questions on the computer each time they have an urge to smoke or they actually smoke. Also, the computer will "beep" at random and set times and request that participant answers some questions.

Participant will return for 4 visits after the orientation session. During these visits, participant will receive brief individual counseling where they will discuss techniques to help them quit smoking. Participant will also be asked to fill out questionnaires on a computer about their moods and feelings, as well as their smoking status. The questionnaires should take about 30 minutes to complete. The breath test will be given at every clinic visit.

Participant may be contacted by mail, telephone, and/or e-mail throughout the study and follow-up period, to provide reminders of clinic visits. Participant may also be asked for information about their smoking status during the usual reminder calls and/or calls to reschedule missed appointments.

A supply of the nicotine patch will be provided to participant at each counseling session. The final supply of the patch is provided at the final counseling session.

This is an investigational study. The nicotine patch used in this study is approved by the Food and Drug Administration (FDA). About 20 people will take part in a pilot phase of this study; then, another 200 participants will take part in the main study. All will be enrolled at M. D. Anderson.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 220
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

1. Age 18 to 65 years.

2. Current smoker with a history of at least 5 cigarettes/day for the last year

3. Motivated to quit within the next week.

4. Home address and a functioning home telephone number.

5. Can speak, read, and write in English at a sixth-grade literacy level.

Exclusion Criteria:

1. Contraindication for nicotine patch use.

2. Active substance abuse or dependence.

3. Regular use of tobacco products other than cigarettes (cigars, pipes, smokeless).

4. Use of bupropion or nicotine products other than the nicotine patches supplied by the study.

5. Pregnancy or lactation.

6. Another household member enrolled in the study.

7. Participation in a smoking cessation program or study during the past 90 days.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Nicotine Replacement Therapy
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.
Behavioral:
Questionnaire
Survey taking 1 and 1/2 hours at each study visit.

Locations

Country Name City State
United States University of Texas MD Anderson Cancer Center Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Risk Perceptions Over Time Among Smokers and Non Smokers Primary hypothesis is that abstainers will show higher risk perceptions than relapsers. 4 weeks
See also
  Status Clinical Trial Phase
Completed NCT03999411 - Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients Phase 4
Completed NCT03931772 - Online Automated Self-Hypnosis Program N/A
Completed NCT02649556 - A 26-week Extension of the ZRHR-ERS-09-US Study Evaluating Biological and Functional Changes in Healthy Smokers After Switching to THS 2.2 N/A
Completed NCT03901066 - Smoking Dependence and Periodontitis
Recruiting NCT05846841 - Personalized Tobacco Treatment in Primary Care (MOTIVATE) N/A
Completed NCT03170752 - Implementing and Testing a Cardiovascular Assessment Screening Program (CASP) N/A
Completed NCT03305978 - Pulmonary Nodule Detection: Comparison of an Ultra Low Dose vs Standard Scan. N/A
Completed NCT00000437 - Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone) Phase 4
Completed NCT06105424 - BRP1602: Evaluation of Technical and Logistical Feasibility to Measure Lung Permeability N/A
Active, not recruiting NCT02752022 - Monitoring the Transition From Smoking to E-cigarettes
Completed NCT04340830 - The Effect of Smoking on Dimensional Changes of Free Gingival Graft Around Dental Implants N/A
Completed NCT03206619 - A Health Recommeder System to Tailor Message Preferences in a Smoking Cessation Programme
Completed NCT02901171 - The Contribution of a Smartphone Application to Acceptance and Commitment Therapy Group Treatment for Smoking Cessation N/A
Completed NCT02912000 - TEACH: Technology Evaluation to Address Child Health N/A
Completed NCT02949648 - Electronic Cigarette Use and Quitting in Youth N/A
Completed NCT02945371 - Tailored Inhibitory Control Training to Reverse EA-linked Deficits in Mid-life N/A
Completed NCT02246114 - Self-Monitoring of Carbon Monoxide to Enhance Reproductive Outcomes in Women N/A
Completed NCT01954407 - Young Adults' Responses to Anti-smoking Messages N/A
Completed NCT02008292 - Acetylcholine, Tobacco Smoking, Genes and Nicotinic Receptors N/A
Completed NCT01898507 - Nicotine Metabolism and Low Nicotine Cigarettes N/A