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Enhancing the Efficacy of Smoking Quit Line in the Military (AFIII Renewal) (Freedom)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02201810
Recruitment Status : Unknown
Verified September 2016 by University of Tennessee.
Recruitment status was:  Recruiting
First Posted : July 28, 2014
Last Update Posted : September 16, 2016
Information provided by (Responsible Party):
University of Tennessee

Brief Summary:
This study is a randomized clinical trial designed to measure the effectiveness of three QL interventions for smokers who failed to quit an initial smoking cessation intervention, but remain motivated to quit smoking.

Condition or disease Intervention/treatment Phase
Initial Efficacy of Quit Line Efficacy of Secondary Reengagement Intervention Behavioral: Rate reduction intervention Behavioral: Recycling Group Behavioral: Choice Group Behavioral: Proactive QL Phase 3

Detailed Description:

In the investigators' previous QL protocol, FWH20080093H, the investigators documented that a military-tailored QL was associated with high rates of sustained smoking cessation. The proactive QL produced superior cessation rates at a one year follow-up compared to a reactive QL. Unfortunately, even with high rates of cessation, a large number of participants (the majority of participants) fail to remain quit at follow-up. Civilian QLs have observed the same marked decay of sustained cessation rates from the end of treatment to the one year follow-up.

An opportunity exists to reengage these smokers who relapse or fail to quit by the end of QL treatment. Civilian QLs use one of two treatments, Recycling (repeat the smoking cessation counseling) or Rate Reduction (cut down over time), as the primary methods for treatment reengagement. Unfortunately, these methods of reengaging the relapsed/failed to quit smoker have not been systematically evaluated. As such, we propose to randomize participants who relapse or fail to quit by the end of the intervention to either (1) repeating the proactive QL (Recycle); (2) smoking reduction with the goal of eventual cessation (Rate Reduction); or (3) the choice of Recycle or Rate Reduction (Choice). Efficacy will be established by assessing both point prevalence and continuous abstinence at a 12 month follow-up.

All participants (approximately 1900) are consented to follow-up treatment reengagement since we do not know a priori who will quit and who will not quit/relapse. The investigators anticipate, based on the investigators' QL study that about 30% will quit and remain quit based on the eight-week proactive QL and about 70% will either not quit or relapse (n≈1300). Those that are smoking at the three-month follow-up are stratified (based on whether they quit and relapsed vs. not quitting at all in the Proactive QL based upon self-report) and randomized to the three treatment reengagement strategies (Recycle, Rate Reduction, or Choice), each one lasting 8 weeks. Then, at one year follow-up, the investigators will assess both point prevalence and continuous abstinence. Since we are intervening on those that initially failed to quit or relapsed, continuous abstinence will be defined from the point of the last treatment reengagement intervention (one year from that point).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1900 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Enhancing the Efficacy of Smoking Quit Line in the Military
Study Start Date : May 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Experimental: 2nd level intervention: Rate Reduction
Rate reduction intervention
Behavioral: Rate reduction intervention
Behavioral: Proactive QL
Experimental: 2nd level intervention: Recycling
Recycling Group
Behavioral: Recycling Group
Behavioral: Proactive QL
Experimental: 2nd level intervention: Choice
Choice Group
Behavioral: Choice Group
Behavioral: Proactive QL

Primary Outcome Measures :
  1. Effectiveness of randomized reengagement interventions [ Time Frame: From 3 months follow up to 1 year follow up ]
    We will assess tobacco status (both 7-day point prevalence and continuous abstinence) at the follow-up period (one year after reengagement interventions are completed) to assess outcome.

Secondary Outcome Measures :
  1. One-year outcome from the initially successful group that quit smoking [ Time Frame: 1-yr after intial randomization ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria: To be included, individuals will be

  • Active Duty, Retired, or Dependent with Tricare benefits
  • Participants must be at least 18 years old
  • Smoked five or more cigarettes a day for at least one year
  • Live in the 48 contiguous states, Alaska or Hawaii
  • Participants must have the ability to understand consent procedures, and have access to a telephone for participation
  • Seriously thinking of quitting smoking cigarettes in the next 30 days

Exclusion Criteria:

  • Persons who have a known or unknown knowledge of an allergy or hypersensitivity to Nicotine Replacement Therapy (NRT)
  • Women who are pregnant, breastfeeding or planning to become pregnant during the next 12 months
  • Persons diagnosed with an unstable heart condition will be excluded as NRT is contraindicated in these groups

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 identifier (NCT number): NCT02201810

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Contact: Wayne Talcott, PhD 210-292-3504
Contact: Karen LeRoy, RN 210-292-3504

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United States, Texas
Wilford Hall Ambulatory Surgical Center Recruiting
Lackland AFB, Texas, United States, 78236
Contact: Karen LeRoy, RN    210-292-3504   
Principal Investigator: Wayne Talcott, PhD         
Sponsors and Collaborators
University of Tennessee
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Principal Investigator: Robert Klesges, PhD UTHSC
Principal Investigator: Wayne Talcott, PhD UTHSC
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Responsible Party: University of Tennessee Identifier: NCT02201810    
Other Study ID Numbers: FWH20140076H
First Posted: July 28, 2014    Key Record Dates
Last Update Posted: September 16, 2016
Last Verified: September 2016
Keywords provided by University of Tennessee:
smoking cessation
quit line
nicotine replacement therapy
tobacco intervention