Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R18HL053478-07A2 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Reactive group | Experimental | Participant will contact the research study staff to initiate the program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine Patch | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Continuous Abstinence | No cigarette smoking since two weeks after the target quit date. | Measured at Year 1 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert C. Klesges, PhD | University of Tennessee Health Science Center and St. Jude Childrens' Research Hospital | Principal Investigator |
| Harry Lando, PhD | University of Minnesota | Principal Investigator |
| Gerald W. Talcott, Ph.D. Colonel (Ret.) | Wilford Hall Medical Center; University of Tennessee Health Science Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Tennessee Health Science Center | Memphis | Tennessee | 38105 | United States | ||
| Wilford Hall Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12002168 | Background | 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. | |
| 15010446 | Background | Mokdad 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Proactive Group | Study staff will initiate contact to conduct 6 individual counseling sessions. Participants will receive 8 weeks of Nicotine Replacement Therapy in the form of a patch. |
| FG001 | Reactive Group | Participant will initiate contact with participant to conduct 6 individual counseling sessions. Participants will receive 2 weeks of Nicotine Replacement Therapy in the form of a patch. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Proactive Group | Research study staff will contact participant to initiate sessions. 8 weeks of Nicotine Replacement Therapy in the form of patch will be distributed this group. Six sessions will be proactively delivered to the participant. 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Continuous Abstinence | No cigarette smoking since two weeks after the target quit date. | Participants | Posted | Count of Participants | Participants | Measured at Year 1 |
|
1 year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Proactive Group | Study staff will initiate contact to conduct 6 individual counseling sessions. Participants will receive 8 weeks of Nicotine Replacement Therapy in the form of a patch. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | MedDRA (10.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Klesges | University of Tennessee Health Science Center | 901-448-3174 | lcolvin1@uthsc.edu |
Not provided
| ID | Term |
|---|---|
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Tobacco Quit Line Program | Behavioral | 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. |
|
| Lackland Air Force Base |
| Texas |
| 78236 |
| United States |
| Background | Bray 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 |
| Background | 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 |
| 15163928 | Background | 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. |
| Background | Department of Defense: Tobacco use prevention strategic plan., in, Washington, D.C., Department of Defense, 1999 |
| Background | Department of Defense: Smoking in DoD occupied buildings and facilities., in, Washington, DC, Department of Defense, 1977, p Instruction No. 6015.6018 |
| Background | 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) |
| Background | 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 |
| 15080246 | Background | 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. |
| 2503780 | Background | Cronan TA, Conway TL, Hervig LK. Evaluation of smoking interventions in recruit training. Mil Med. 1989 Jul;154(7):371-5. |
| 26226536 | Derived | Klesges 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. |
| BG001 | Reactive Group | Participant will contact the research study staff to initiate sessions. 2 weeks of Nicotine Replacement Therapy in the form of patch will be distributed this group. Six sessions will be delivered to the participant as long as the participant calls to initiate the sessions. 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. 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 16 |
| 649 |
| 307 |
| 649 |
| EG001 | Reactive Group | Participant will initiate contact with participant to conduct 6 individual counseling sessions. Participants will receive 2 weeks of Nicotine Replacement Therapy in the form of a patch. | 6 | 649 | 98 | 649 |
| Skin Rash | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Sleep Disturbance | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Respiratory illness/ Sinus/ Sore throat/ Cold/Flu/Seasonal allergies | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Stomach illness/Nausea/Diarrhea | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Pain/Joint Pain/Muscle Aches/ Back Pain | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Anxiety/Irritability | Psychiatric disorders | Non-systematic Assessment |
|
| Fatigue/Lethargy | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Increased Heart Rate/Heart Palpitations | Cardiac disorders | Non-systematic Assessment |
|
| Injury: knee/foot | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Hernia | Renal and urinary disorders | Non-systematic Assessment |
|
| Gall bladder surgery | Surgical and medical procedures | Non-systematic Assessment |
|
| Urinary Tract Infection, Bladder problems | Renal and urinary disorders | Non-systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | Non-systematic Assessment |
|
| Elevated Blood Pressure | Cardiac disorders | Non-systematic Assessment |
|
| Ringing in Ears | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Ear Infection | Infections and infestations | Non-systematic Assessment |
|
| Skin biopsy | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
Not provided
Not provided