Clinical trial NCT02329249: Pharmacological Aids for Interactive Smoking Cessation
Official title: Pharmacological Aids for Interactive Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: smoking cessation
coach-supported
tobacco use cessation
online
internet-based
tailored
Lead sponsor: Oregon Center for Applied Science, Inc.
Sponsor class: INDUSTRY
First posted: 2014-12-31
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Smoking cessation
timeFrame: 120 days
Secondary outcomes:
measure: Intentions to quit smoking
timeFrame: 30 days and 120 days after baseline
measure: intentions to quit and remain smokefree
timeFrame: 30 days and 120 days after baseline
measure: self-efficacy for quitting
timeFrame: 30 days and 120 days after baseline
measure: intentions to use a pharmacological smoking cessation aid (PA)
timeFrame: 30 days and 120 days after baseline
Other outcomes:
Locations:
Study officials:
affiliation: Oregon Center for Applied Science
name: Susan Schroeder, MPH, MCHES
role: PRINCIPAL_INVESTIGATOR
References: