Enhancing the Efficacy of Smoking Quit Line in the Military (AFIII Renewal)
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | May 2015 |
End Date: | December 2017 |
Contact: | Wayne Talcott, PhD |
Email: | gerald.talcott@gmail.com |
Phone: | 210-292-3504 |
Enhancing the Efficacy of Smoking Quit Line in the Military
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.
interventions for smokers who failed to quit an initial smoking cessation intervention, but
remain motivated to quit smoking.
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).
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).
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
We found this trial at
1
site
Lackland AFB, Texas 78236
Principal Investigator: Wayne Talcott, PhD
Phone: 210-292-3504
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