Pharmacological Aids for Interactive Smoking Cessation

NCT ID: NCT02329249

Last Updated: 2015-01-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-02-28
• Study Completion Date: 2006-01-31

Brief Summary

There is an important need for effective smoking cessation programs that both (a) promote the effective use of pharmacological aids, such as nicotine replacement products and bupropion, and (b) provide cognitive-behavioral support for stopping smoking.The Internet is an increasingly attractive intervention medium for delivering behavior change interventions, including smoking cessation.This study examined smoking cessation rates among adults participating in a randomized controlled trial of the Smokefree Partners: 21 Days to Freedom ™ program, a theoretically based, online smoking cessation program that included message tailoring and interactivity combined with the live personal support of a smoking cessation coach. Coaching support was provided almost entirely asynchronously via prescripted but individually tailored emails.

Detailed Description

The Smokefree Partners: 21 Days to Freedom combined online video, text, and interactive tools to promote the effective use of pharmacological aids (PA) - nicotine replacement products and bupropion (Zyban®) - and provide cognitive-behavioral support for users as they attempted to stop smoking. Smoking cessation content was based on the U.S. Surgeon General's Clinical Guidelines, Treating Tobacco Use and Dependence, 2008 update. Presentation of some of the content (e.g., gender of the narrator, PA recommendations) was tailored to the user on demographic and smoking history information provided during registration and within the introductory session.

Two critical features provided social support and accountability. First, each user was assigned a "live" smoking cessation coach to provide support via individually tailored phone or email contacts (contact preference specified by the user). Users also received automated email reminders and prompts from the program. Second, a bulletin board/forum feature was added to promote social support among users.

The Smokefree Partners intervention was a multi-session intervention in which users experienced a controlled and scheduled exposure to 21 discrete web site sessions. The program required users to wait at least 10 hours between sessions (i.e., login was "locked" until 10 hours had passed after a user's previous Web site session). Carefully timed and tailored coaching messages provided cessation tips and prompted users to return to the web site to view the next session.

The program was evaluated online in a randomized clinical trial of smokers recruited through major worksites across the United States. The aim of the evaluation was to determine if a theoretically based, online smoking cessation program that included message tailoring and interactivity combined with the live personal support of a coach would result in improved quit rates when compared to a wait-list control condition.

Conditions

Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Smokefree Partners: 21 Days to Freedom

Smoking cessation website program with live personal coach

Group Type: EXPERIMENTAL

Smokefree Partners: 21 Days to Freedom

Intervention Type: BEHAVIORAL

Treatment subjects, who chose a quit date, were given 21 sessions to be viewed one session (i..e, one day) at a time, and an in-person smoking cessation coach to support them through their quit process via tailored email or phone coaching messages. Treatment users were encouraged to use pharmacological aids in their quit attempt, but smoking cessation aids were not provided.

Wait-list control

120-day wait-list and then provided access to the smoking cessation website

Group Type: OTHER

Wait-List Control

Intervention Type: OTHER

Subjects randomized to the control condition were placed on a wait-list and given access to the smoking cessation program after 120 days and completion of the 120-day follow-up assessment.

Interventions

Smokefree Partners: 21 Days to Freedom

Treatment subjects, who chose a quit date, were given 21 sessions to be viewed one session (i..e, one day) at a time, and an in-person smoking cessation coach to support them through their quit process via tailored email or phone coaching messages. Treatment users were encouraged to use pharmacological aids in their quit attempt, but smoking cessation aids were not provided.

Intervention Type: BEHAVIORAL

Wait-List Control

Subjects randomized to the control condition were placed on a wait-list and given access to the smoking cessation program after 120 days and completion of the 120-day follow-up assessment.

Intervention Type: OTHER

Other Intervention Names

Pharmacological Aids for Interactive Smoking Cessation

Eligibility Criteria

Inclusion Criteria

• large worksites with internet connection
• thinking of quitting smoking
• 18 years of age or older

Exclusion Criteria

• not thinking of quitting smoking
• 17 years of age or younger

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oregon Center for Applied Science, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Susan Schroeder

Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan Schroeder, MPH, MCHES

Role: PRINCIPAL_INVESTIGATOR

Oregon Center for Applied Science

Other Identifiers

R44CA077986

Identifier Type: NIH

Identifier Source: secondary_id

View Link

SBIR37R-2

Identifier Type: -

Identifier Source: org_study_id