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Pharmacological Aids for Interactive Smoking Cessation (NRT_2)

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ClinicalTrials.gov Identifier: NCT02329249
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : January 1, 2015
Sponsor:
Information provided by (Responsible Party):
Susan Schroeder, Oregon Center for Applied Science, Inc.

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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Smokefree Partners: 21 Days to Freedom Other: Wait-List Control Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacological Aids for Interactive Smoking Cessation
Study Start Date : February 2001
Actual Primary Completion Date : January 2005
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Smokefree Partners: 21 Days to Freedom
Smoking cessation website program with live personal coach
Behavioral: 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.
Other Name: Pharmacological Aids for Interactive Smoking Cessation

Wait-list control
120-day wait-list and then provided access to the smoking cessation website
Other: 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.




Primary Outcome Measures :
  1. Smoking cessation [ Time Frame: 120 days ]
    Current smoking status was determined with two items: (a) a stage of change measure indicating smoking status and (b) a measure indicating the number of cigarettes smoked in the past 7 days. Abstinence at 30-day posttest and 120-day follow-up was confirmed by the participant choosing both (a) the response of "I do not currently smoke; I quit in the last 6 months" to the stage of change measure and (b) a response of "0" to the question "During the past 7 days, how many cigarettes did you smoke each day?"


Secondary Outcome Measures :
  1. Intentions to quit smoking [ Time Frame: 30 days and 120 days after baseline ]
    1 item assessing the user's likelihood of quitting smoking within the next 30 days; 1-5 response scale (1=extremely likely, 5=not at all likely)

  2. intentions to quit and remain smokefree [ Time Frame: 30 days and 120 days after baseline ]
    1 item assessing the likelihood of quitting and remaining smokefree; 1-5 response scale (1=extremely likely, 5=not at all likely)

  3. self-efficacy for quitting [ Time Frame: 30 days and 120 days after baseline ]
    2 items assessing the user's confidence to (a) quit smoking and (b) quit and remain smokefree; 1-5 response scale (1=extremely confident, 5=not at all confident)

  4. intentions to use a pharmacological smoking cessation aid (PA) [ Time Frame: 30 days and 120 days after baseline ]
    2 items assessing the user's intention to use (a) a nicotine replacement product or (b) Zyban during this quit attempt; 1-5 response scale (1=extremely likely, 5=not at all likely)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02329249


Sponsors and Collaborators
Oregon Center for Applied Science, Inc.
Investigators
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Principal Investigator: Susan Schroeder, MPH, MCHES Oregon Center for Applied Science

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Responsible Party: Susan Schroeder, Research Scientist, Oregon Center for Applied Science, Inc.
ClinicalTrials.gov Identifier: NCT02329249     History of Changes
Other Study ID Numbers: SBIR37R-2
R44CA077986 ( U.S. NIH Grant/Contract )
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: January 1, 2015
Last Verified: December 2014

Keywords provided by Susan Schroeder, Oregon Center for Applied Science, Inc.:
smoking cessation
coach-supported
tobacco use cessation
online
internet-based
tailored