MDACC Study Summary ID01-234

Study Summary
No. ID01-234:.......Psychosocial......David Wetter......Health Disparities Research

Study Summary Title



Study Summary Number:	ID01-234

Study Title:	Treatment of Nicotine Dependence Among African Americans

Physician

New Patient Referral



Name:	David Wetter	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Health Disparities Research	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-2682 Contact us about clinical trials

General Information



Disease Group:	Psychosocial	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Participants will have 7 visits: a screening/orientation visit and 6 study visits (2 pre-cessation; 3 post-cessation, 1 follow-up 26 weeks after quit date).

Treatment Agents:	Nicotine Psychosocial	Home Care:	All participants will receive 6 weeks of nicotine patch therapy and self-help materials. Staff will instruct on patch use. MD will evaluate/consult on any patch problems. Telephone contact with staff is available.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this behavioral research study is to study a computer-delivered smoking cessation treatment for African-Americans.

Study Objectives / Outcomes

The purpose of this project is to develop and evaluate a culturally appropriate, computer-delivered smoking cessation treatment for African American (AA) smokers. Participants (N=500; including approximately 20 participants enrolled in the pilot phase of the study) will be randomly assigned to receive standard care (SC) consisting of nicotine patch therapy, culturally sensitive self-help material, and individual counseling; or standard care plus interactive, real time palmtop computer-delivered treatment (CDT). Traditional behavioral interventions lack effectiveness in responding to high-risk situations/lapses because they are physically and temporally removed from these episodes. Unlike conventional treatments, CDT can deliver an appropriate intervention precisely when needed because it is carried with the smoker and is available on demand in natural settings.
Interactive computer-delivered interventions have the potential to produce significant advances in the individualization, accessibility, and acceptability of behavioral treatments for nicotine dependence, and if effective, would have broad clinical and public health applications. It is critically important that minority populations (particularly those at high risk for adverse health consequences) have access to new health behavior technologies.
The objectives of this project are to:

1. Develop/evaluate the efficacy of an interactive, culturally sensitive, individualized, palmtop computer-delivered smoking cessation intervention for AAs

2. Examine how hypothesized treatment mechanisms mediate the effects of CDT on abstinence.

Study Status Information



Study Activation / Registration Date:	04/08/2002

IRB Review and Approval Date:	12/15/2004

Study Type:	Therapeutic

Recruitment Status:	Closed

Projected Accrual:	500

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) African American

2) Age 21 to 65 years

3) Current Smoker (history of at least 5 cigarettes/day for the last year)

4) Motivated to quit within the next 14 days

5) Participants must provide a viable home address and functioning home telephone number

6) Can speak, read, write in English at a sixth-grade literacy level

7) Provide viable collateral contact information

8) Register "8" or more on a carbon monoxide breath test

Exclusion Criteria:

1) Contraindication for nicotine patch use

2) Active substance dependence (exclusive of nicotine dependence)

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

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

5) Pregnancy or lactation

6) Any active illness that precludes full participation in the study protocol

7) Another household member enrolled in the study

Links

Registration Number: NCT00310141
Study Information on Clinical Trials Registry (clinicaltrials.gov)