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.|
|ClinicalTrials.gov 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
|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|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1900 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: 2nd level intervention: Rate Reduction
Rate reduction intervention
Behavioral: Rate reduction intervention
Behavioral: Proactive QL
Experimental: 2nd level intervention: Recycling
Behavioral: Recycling Group
Behavioral: Proactive QL
Experimental: 2nd level intervention: Choice
Behavioral: Choice Group
Behavioral: Proactive QL
- 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.
- One-year outcome from the initially successful group that quit smoking [ Time Frame: 1-yr after intial randomization ]
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): NCT02201810
|Contact: Wayne Talcott, PhDfirstname.lastname@example.org|
|Contact: Karen LeRoy, RNemail@example.com|
|United States, Texas|
|Wilford Hall Ambulatory Surgical Center||Recruiting|
|Lackland AFB, Texas, United States, 78236|
|Contact: Karen LeRoy, RN 210-292-3504 firstname.lastname@example.org|
|Principal Investigator: Wayne Talcott, PhD|
|Principal Investigator:||Robert Klesges, PhD||UTHSC|
|Principal Investigator:||Wayne Talcott, PhD||UTHSC|