Initial Efficacy of Quit LineFreedomNCT02201810
Enhancing the Efficacy of Smoking Quit Line in the Military (AFIII Renewal)
A study testing Rate reduction intervention, Recycling Group and Choice Group in people with Initial Efficacy of Quit Line and Efficacy of Secondary Reengagement Intervention, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Initial Efficacy of Quit Line, Efficacy of Secondary Reengagement Intervention
- What is being tested?
- Rate reduction intervention, Recycling Group and Choice Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 614 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to 30 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wilford Hall Ambulatory Surgical Center
Lackland Air Force Base, Texas, 78236
About this study
Official title: 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.
Read the 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).
- Being tested
- Rate reduction intervention, Recycling Group, Choice Group, Proactive QL
- Keywords
- smoking cessation, quit line, nicotine replacement therapy, tobacco intervention
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rate reduction interventionBehavioural
Recycling GroupBehavioural
Choice GroupBehavioural
Proactive QLBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 2nd level intervention: Rate Reduction | Experimental | Rate reduction intervention Receives: Behavioral: Rate reduction intervention; Behavioral: Proactive QL |
| 2nd level intervention: Recycling | Experimental | Recycling Group Receives: Behavioral: Recycling Group; Behavioral: Proactive QL |
| 2nd level intervention: Choice | Experimental | Choice Group Receives: Behavioral: Choice Group; Behavioral: Proactive QL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of randomized reengagement interventions
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.
Measured: From 3 months follow up to 1 year follow up
Secondary outcomes (1)
One-year outcome from the initially successful group that quit smoking
Measured: 1-yr after initial randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2014 (estimated)
- Study startMay 2015
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Initial Efficacy of Quit LineStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 614 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tennessee
- Responsible party
- Principal investigator, Melissa Little, PhD, MPH, University of Virginia
- Investigators
- Robert Klesges, PhD, Principal investigator, UTHSCWayne Talcott, PhD, Principal investigator, UTHSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02201810
- Sponsor's protocol ID
- FWH20140076H
- Acronym
- Freedom
- Status last verified
- May 2022
- First submitted
- 24 Jul 2014
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Little MA, Ebbert JO, Bursac Z, Talcott GW, Talley L, LeRoy KM, Womack CR, Hryshko-Mullen AS, Klesges RC. Enhancing the efficacy of a smoking quit line in the military: Study rationale, design and methods of the Freedom quit line. Contemp Clin Trials. 2017 Aug;59:51-56. doi: 10.1016/j.cct.2017.04.011. Epub 2017 May 4. No abstract available.
PubMed 28479219Cassidy DG, Wang XQ, Mallawaarachchi I, Wiseman KP, Ebbert JO, Blue Star JA, Aycock CA, Estevez Burns R, Jones JR, Krunnfusz AE, Halbert JP, Roy NM, Ellis JM, Williams JB, Klesges RC, Talcott GW. Tobacco quitline performance: Comparing the impacts of early cessation and proactive re-engagement on callers' smoking status at follow-up at 12 months. Tob Induc Dis. 2023 Feb 15;21:24. doi: 10.18332/tid/159125. eCollection 2023.
PubMed 36798676Wiseman KP, Aycock CA, Mallawaarachchi I, Wang XQ, Cassidy DG, Patience MA, Little MA, Talcott GW, Klesges RC. Predictors of Re-Engagement after Relapse in a Tobacco Quit Line Intervention: Secondary Analysis from a Randomized Clinical Trial. Int J Environ Res Public Health. 2023 Jan 10;20(2):1229. doi: 10.3390/ijerph20021229.
PubMed 36673992
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing the Efficacy of Smoking Quit Line in the Military
- ClinicalTrials.gov ID
- NCT02201810
- Acronym / sponsor ID
- Freedom / FWH20140076H
- Keywords
- smoking cessation, quit line, nicotine replacement therapy, tobacco intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 614 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- University of Tennessee
- Study start
- May 2015 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 28 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2nd level intervention: Rate Reduction | Experimental | Behavioral: Rate reduction intervention, Behavioral: Proactive QLRate reduction intervention |
| 2nd level intervention: Recycling | Experimental | Behavioral: Recycling Group, Behavioral: Proactive QLRecycling Group |
| 2nd level intervention: Choice | Experimental | Behavioral: Choice Group, Behavioral: Proactive QLChoice Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rate reduction intervention | Behavioural | 2nd level intervention: Rate Reduction |
| Recycling Group | Behavioural | 2nd level intervention: Recycling |
| Choice Group | Behavioural | 2nd level intervention: Choice |
| Proactive QL | Behavioural | 2nd level intervention: Choice, 2nd level intervention: Rate Reduction, 2nd level intervention: Recycling |
Primary outcome
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.
1 secondary outcome
One-year outcome from the initially successful group that quit smoking
Time frame: 1-yr after initial randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Background: PubMed 28479219Little MA, Ebbert JO, Bursac Z, Talcott GW, Talley L, LeRoy KM, Womack CR, Hryshko-Mullen AS, Klesges RC. Enhancing the efficacy of a smoking quit line in the military: Study rationale, design and methods of the Freedom quit line. Contemp Clin Trials. 2017 Aug;59:51-56. doi: 10.1016/j.cct.2017.04.011. Epub 2017 May 4. No abstract available.
- Derived from this study: PubMed 36798676Cassidy DG, Wang XQ, Mallawaarachchi I, Wiseman KP, Ebbert JO, Blue Star JA, Aycock CA, Estevez Burns R, Jones JR, Krunnfusz AE, Halbert JP, Roy NM, Ellis JM, Williams JB, Klesges RC, Talcott GW. Tobacco quitline performance: Comparing the impacts of early cessation and proactive re-engagement on callers' smoking status at follow-up at 12 months. Tob Induc Dis. 2023 Feb 15;21:24. doi: 10.18332/tid/159125. eCollection 2023.
- Derived from this study: PubMed 36673992Wiseman KP, Aycock CA, Mallawaarachchi I, Wang XQ, Cassidy DG, Patience MA, Little MA, Talcott GW, Klesges RC. Predictors of Re-Engagement after Relapse in a Tobacco Quit Line Intervention: Secondary Analysis from a Randomized Clinical Trial. Int J Environ Res Public Health. 2023 Jan 10;20(2):1229. doi: 10.3390/ijerph20021229.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Klesges, PhD principal investigator
UTHSC
Wayne Talcott, PhD principal investigator
UTHSC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rate reduction intervention, Recycling Group and Choice Group in people with Initial Efficacy of Quit Line and Efficacy of Secondary Reengagement Intervention, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of randomized reengagement interventions (time frame: From 3 months follow up to 1 year follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02201810, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022.