SmokingAFIIINCT00632411
Evaluating a Telephone-Based Smoking Cessation Program Among People in the Military (The AFIII Study)
A study testing Nicotine Patch and Tobacco Quit Line Program in people with Smoking and Smoking Cessation, run by University of Tennessee at 2 sites in United States.
Trial summary
Rates of cigarette smoking in the military are high. Tobacco telephone quit lines are telephone-based services that provide information and guidance to people who want 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
- Smoking, Smoking Cessation
- What is being tested?
- Nicotine Patch and Tobacco Quit Line Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,298 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2008to Jul 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Department of Defense healthcare beneficiary
- Has smoked five or more cigarettes per day for at least 1 year before study entry
- Must be at least eighteen years old
Who cannot join
- Known allergy or sensitivity to nicotine replacement therapy
- No telephone
- Inability to understand consent procedures
- Basic Military Trainee
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Wilford Hall Medical Center
Lackland Air Force Base, Texas, 78236
University of Tennessee Health Science Center
Memphis, Tennessee, 38105
About this study
Official title: Efficacy of a Smoking Quit Line in the Military
Rates of cigarette smoking in the military are high. Tobacco telephone quit lines are telephone-based services that provide information and guidance to people who want to quit smoking. This study will evaluate the effectiveness of a tobacco quit line program, in addition to nicotine replacement patches, at helping people in the military quit smoking cigarettes.
Read the detailed description
Active duty military personnel are at high risk of cigarette smoking. Despite strong efforts by the Department of Defense to reduce tobacco use, rates of smoking among people in the military remain high. The military lifestyle presents unique challenges to implementing smoking cessation programs, including the high mobility of troops, remote locations, and limited access to healthcare services. Because of these challenges, many smoking cessation programs that are effective in the non-military population are often ineffective in the military population. Tobacco telephone quit lines are telephone-based tobacco cessation services that provide easy access to educational materials, referrals to local programs, and individualized telephone counseling. Because tobacco quit lines are remotely based and can fit into varying schedules at convenient times, they may be effective among people in the military. Nicotine replacement patches are another effective smoking cessation tool and can be used in addition to telephone quit lines. The purpose of this study is to evaluate the effectiveness of tobacco quit lines, in addition to nicotine replacement patches, at improving smoking cessation rates among members of the Air Force.
This study will enroll military healthcare beneficiaries who have smoked at least five cigarettes a day in the year before study entry. Participants will be randomly assigned to either a proactive group, in which study researchers will initiate contact with the participants, or a reactive group, in which participants will initiate contact with the researchers. In this six-session program, phone calls will occur at 1- to 2-week intervals over an 8-week period. The phone sessions will focus on cutting down on cigarette smoking, setting a quit date, and relapse prevention. All participants will receive nicotine replacement patches after the second session is completed. The reactive group will receive two weeks of nicotine replacement patches and the proactive group will receive 8 weeks of nicotine replacement patches. At the end of session four and 1 year later, study staff will call participants to collect information on tobacco abstinence, nicotine replacement patch use adherence, and other smoking cessation medication use.
- Conditions
- Smoking, Smoking Cessation
- Being tested
- Nicotine Patch, Tobacco Quit Line Program
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine PatchDrug
Participants who smoke more than 20 cigarettes per day will use a 21-mg patch for 4 weeks, a 14-mg patch for the next 2 weeks, a 7-mg patch for the next 2 weeks, and then no patch.
Participants who smoke between 10 to 19 cigarettes per day will use a 14-mg patch for 4 weeks, a 7-mg patch for the next 4 weeks, and then no patch.
Participants who smoke between 5 to 9 cigarettes per day will use a 7-mg patch for 8 weeks and then no patch.
The proactive group will be given 8 weeks of patch treatment and the reactive group will be given 2 weeks of patch treatment.
Tobacco Quit Line ProgramBehavioural
Phone session 1 will focus on smoking reduction.
Phone session 2 will focus on preparing to quit and surviving the first days as a non-smoker. A quit date will be set in 7 to 10 days. Nicotine patches will be sent to participant with detailed instructions for patch use.
Phone session 3 will focus on the first days after the quit date.
Phone session 4 will focus on a review of progress and challenges of quitting. Plans to manage high-risk situations will be discussed.
Phone session 5 will focus on short-term relapse prevention.
Phone session 6 will focus on long-term relapse prevention.
| Study group | Role | What they receive |
|---|---|---|
| Proactive group | Experimental | Research study staff will contact participant to initiate the program. Half of participants will be randomized to the proactive condition and the other half to the reactive conditions. Receives: Drug: Nicotine Patch; Behavioral: Tobacco Quit Line Program |
| Reactive group | Experimental | Participant will contact the research study staff to initiate the program. Receives: Drug: Nicotine Patch; Behavioral: Tobacco Quit Line Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous Abstinence
No cigarette smoking since two weeks after the target quit date.
Measured: Measured at Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2008 (estimated)
- Study startApr 2008
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 1,298 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Robert C. Klesges, PhD, Principal investigator, University of Tennessee Health Science Center and St. Jude Childrens' Research HospitalHarry Lando, PhD, Principal investigator, University of MinnesotaGerald W. Talcott, Ph.D. Colonel (Ret.), Principal investigator, Wilford Hall Medical Center; University of Tennessee Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00632411
- Sponsor's protocol ID
- 524
- Other IDs
- R18HL053478-07A2
- Acronym
- AFIII
- Status last verified
- Sep 2016
- First submitted
- 6 Mar 2008
- Last updated
- 14 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Centers for Disease Control and Prevention (CDC). Annual smoking-attributable mortality, years of potential life lost, and economic costs--United States, 1995-1999. MMWR Morb Mortal Wkly Rep. 2002 Apr 12;51(14):300-3.
PubMed 12002168Mokdad AH, Marks JS, Stroup DF, Gerberding JL. Actual causes of death in the United States, 2000. JAMA. 2004 Mar 10;291(10):1238-45. doi: 10.1001/jama.291.10.1238.
PubMed 15010446Bray RM, Hourani LL, Rae KL, al. e: Department of Defense Survey of Health Related Behaviors Among Military Personnel, in Report No. RTI/7841/006-FR, Research Triangle Park, NC, RTI International, 2003
U.S. Department of Health and Human Services: The health consequences of smoking; a report of the surgeon general., in, Atlanta, GA, USDHHS, Centers for Disease Control and Prevention, National Center for Chronic Disease and Prevention and Health Promotion, Office on Smoking and Health, 2004
Centers for Disease Control and Prevention (CDC). Cigarette smoking among adults--United States, 2002. MMWR Morb Mortal Wkly Rep. 2004 May 28;53(20):427-31.
PubMed 15163928Department of Defense: Tobacco use prevention strategic plan., in, Washington, D.C., Department of Defense, 1999
Department of Defense: Smoking in DoD occupied buildings and facilities., in, Washington, DC, Department of Defense, 1977, p Instruction No. 6015.6018
Department of Defense: Health promotion., in, Washington, D.C., Department of Defense, 1994b, pp Directive No. 1010.1010 (1010.1010 supersedes and cancels March 1011, 1986, version of Directive No. 1010.1010)
Department of Defense: DoD food and nutrition research, development, testing, evaluation, and engineering program., in, Washington, D.C., Department of Defense, 1983, p Instruction No. 3235.3232
Conway TL, Woodruff SI, Edwards CC, Elder JP, Hurtado SL, Hervig LK. Operation Stay Quit: evaluation of two smoking relapse prevention strategies for women after involuntary cessation during US Navy recruit training. Mil Med. 2004 Mar;169(3):236-42. doi: 10.7205/milmed.169.3.236.
PubMed 15080246Cronan TA, Conway TL, Hervig LK. Evaluation of smoking interventions in recruit training. Mil Med. 1989 Jul;154(7):371-5.
PubMed 2503780Klesges RC, Ebbert JO, Talcott GW, Thomas F, Richey PA, Womack C, Hryshko-Mullen A, Oh J. Efficacy of a Tobacco Quitline in Active Duty Military and TRICARE Beneficiaries: A Randomized Trial. Mil Med. 2015 Aug;180(8):917-25. doi: 10.7205/MILMED-D-14-00513.
PubMed 26226536
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Smoking Quit Line in the Military
- ClinicalTrials.gov ID
- NCT00632411
- Acronym / sponsor ID
- AFIII / 524
- Conditions
- Smoking, Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,298 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Apr 2008
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 10 Mar 2008 (estimated)
- Results
- Posted 24 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rates of cigarette smoking in the military are high. Tobacco telephone quit lines are telephone-based services that provide information and guidance to people who want to quit smoking. This study will evaluate the effectiveness of a tobacco quit line program, in addition to nicotine replacement patches, at helping people in the military quit smoking cigarettes.
Detailed description
Active duty military personnel are at high risk of cigarette smoking. Despite strong efforts by the Department of Defense to reduce tobacco use, rates of smoking among people in the military remain high. The military lifestyle presents unique challenges to implementing smoking cessation programs, including the high mobility of troops, remote locations, and limited access to healthcare services. Because of these challenges, many smoking cessation programs that are effective in the non-military population are often ineffective in the military population. Tobacco telephone quit lines are telephone-based tobacco cessation services that provide easy access to educational materials, referrals to local programs, and individualized telephone counseling. Because tobacco quit lines are remotely based and can fit into varying schedules at convenient times, they may be effective among people in the military. Nicotine replacement patches are another effective smoking cessation tool and can be used in addition to telephone quit lines. The purpose of this study is to evaluate the effectiveness of tobacco quit lines, in addition to nicotine replacement patches, at improving smoking cessation rates among members of the Air Force.
This study will enroll military healthcare beneficiaries who have smoked at least five cigarettes a day in the year before study entry. Participants will be randomly assigned to either a proactive group, in which study researchers will initiate contact with the participants, or a reactive group, in which participants will initiate contact with the researchers. In this six-session program, phone calls will occur at 1- to 2-week intervals over an 8-week period. The phone sessions will focus on cutting down on cigarette smoking, setting a quit date, and relapse prevention. All participants will receive nicotine replacement patches after the second session is completed. The reactive group will receive two weeks of nicotine replacement patches and the proactive group will receive 8 weeks of nicotine replacement patches. At the end of session four and 1 year later, study staff will call participants to collect information on tobacco abstinence, nicotine replacement patch use adherence, and other smoking cessation medication use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proactive group | Experimental | Drug: Nicotine Patch, Behavioral: Tobacco Quit Line ProgramResearch study staff will contact participant to initiate the program. Half of participants will be randomized to the proactive condition and the other half to the reactive conditions. |
| Reactive group | Experimental | Drug: Nicotine Patch, Behavioral: Tobacco Quit Line ProgramParticipant will contact the research study staff to initiate the program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Department of Defense healthcare beneficiary
- Has smoked five or more cigarettes per day for at least 1 year before study entry
- Must be at least eighteen years old
Key exclusion criteria (4 listed)
- Known allergy or sensitivity to nicotine replacement therapy
- No telephone
- Inability to understand consent procedures
- Basic Military Trainee
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 |
|---|---|---|
| Nicotine PatchParticipants who smoke more than 20 cigarettes per day will use a 21-mg patch for 4 weeks, a 14-mg patch for the next 2 weeks, a 7-mg patch for the next 2 weeks, and then no patch. Participants who smoke between 10 to 19 cigarettes per day will use a 14-mg patch for 4 weeks, a 7-mg patch for the next 4 weeks, and then no patch. Participants who smoke between 5 to 9 cigarettes per day will use a 7-mg patch for 8 weeks and then no patch. The proactive group will be given 8 weeks of patch treatment and the reactive group will be given 2 weeks of patch treatment. | Drug | Proactive group, Reactive group |
| Tobacco Quit Line ProgramPhone session 1 will focus on smoking reduction. Phone session 2 will focus on preparing to quit and surviving the first days as a non-smoker. A quit date will be set in 7 to 10 days. Nicotine patches will be sent to participant with detailed instructions for patch use. Phone session 3 will focus on the first days after the quit date. Phone session 4 will focus on a review of progress and challenges of quitting. Plans to manage high-risk situations will be discussed. Phone session 5 will focus on short-term relapse prevention. Phone session 6 will focus on long-term relapse prevention. | Behavioural | Proactive group, Reactive group |
Primary outcome
Continuous Abstinence
Time frame: Measured at Year 1
No cigarette smoking since two weeks after the target quit date.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12002168Centers for Disease Control and Prevention (CDC). Annual smoking-attributable mortality, years of potential life lost, and economic costs--United States, 1995-1999. MMWR Morb Mortal Wkly Rep. 2002 Apr 12;51(14):300-3.
- Background: PubMed 15010446Mokdad AH, Marks JS, Stroup DF, Gerberding JL. Actual causes of death in the United States, 2000. JAMA. 2004 Mar 10;291(10):1238-45. doi: 10.1001/jama.291.10.1238.
- BackgroundBray RM, Hourani LL, Rae KL, al. e: Department of Defense Survey of Health Related Behaviors Among Military Personnel, in Report No. RTI/7841/006-FR, Research Triangle Park, NC, RTI International, 2003
- BackgroundU.S. Department of Health and Human Services: The health consequences of smoking; a report of the surgeon general., in, Atlanta, GA, USDHHS, Centers for Disease Control and Prevention, National Center for Chronic Disease and Prevention and Health Promotion, Office on Smoking and Health, 2004
- Background: PubMed 15163928Centers for Disease Control and Prevention (CDC). Cigarette smoking among adults--United States, 2002. MMWR Morb Mortal Wkly Rep. 2004 May 28;53(20):427-31.
- BackgroundDepartment of Defense: Tobacco use prevention strategic plan., in, Washington, D.C., Department of Defense, 1999
- BackgroundDepartment of Defense: Smoking in DoD occupied buildings and facilities., in, Washington, DC, Department of Defense, 1977, p Instruction No. 6015.6018
- BackgroundDepartment of Defense: Health promotion., in, Washington, D.C., Department of Defense, 1994b, pp Directive No. 1010.1010 (1010.1010 supersedes and cancels March 1011, 1986, version of Directive No. 1010.1010)
- BackgroundDepartment of Defense: DoD food and nutrition research, development, testing, evaluation, and engineering program., in, Washington, D.C., Department of Defense, 1983, p Instruction No. 3235.3232
- Background: PubMed 15080246Conway TL, Woodruff SI, Edwards CC, Elder JP, Hurtado SL, Hervig LK. Operation Stay Quit: evaluation of two smoking relapse prevention strategies for women after involuntary cessation during US Navy recruit training. Mil Med. 2004 Mar;169(3):236-42. doi: 10.7205/milmed.169.3.236.
- Background: PubMed 2503780Cronan TA, Conway TL, Hervig LK. Evaluation of smoking interventions in recruit training. Mil Med. 1989 Jul;154(7):371-5.
- Derived from this study: PubMed 26226536Klesges RC, Ebbert JO, Talcott GW, Thomas F, Richey PA, Womack C, Hryshko-Mullen A, Oh J. Efficacy of a Tobacco Quitline in Active Duty Military and TRICARE Beneficiaries: A Randomized Trial. Mil Med. 2015 Aug;180(8):917-25. doi: 10.7205/MILMED-D-14-00513.
Related trials for Smoking
Active, not recruiting
An Interactive Smartphone Application to Motivate Smokers to Quit
Smoking Cessation, Smoking Behaviors
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruiting
Comparing the Efficacy of a Conversational Agent (QuitBot) Versus Standard Health Education on Smoking Cessation Among Medical Students; A Randomized Controlled Trial.
Conversational Agent, Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Active, not recruitingPhase 3
Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
Tobacco Dependence
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 C. Klesges, PhD principal investigator
University of Tennessee Health Science Center and St. Jude Childrens' Research Hospital
Harry Lando, PhD principal investigator
University of Minnesota
Gerald W. Talcott, Ph.D. Colonel (Ret.) principal investigator
Wilford Hall Medical Center; University of Tennessee Health Science Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine Patch and Tobacco Quit Line Program in people with Smoking and Smoking Cessation, run by University of Tennessee at 2 sites 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 3 inclusion and 4 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 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 24 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Continuous Abstinence (time frame: Measured at Year 1). 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 NCT00632411, which also lists 12 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 14 Mar 2018.