Evaluating a Telephone-Based Smoking Cessation Program Among People in the Military (The AFIII Study)

• Sponsor: University of Tennessee (Other)
• Overall Status: Completed
• CT.gov ID: NCT00632411
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 1,298
• Locations: 2
• Arms: 2
• Duration (Months): 75
• Patients Per Site: 649
• Patients Per Site Per Month: 8.7

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Smoking; Smoking Cessation	Drug: Nicotine Patch; Behavioral: Tobacco Quit Line Program	N/A

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

• Study Type: Interventional
• Actual Enrollment: 1298 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy of a Smoking Quit Line in the Military
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Proactive group 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.	Drug: Nicotine Patch; 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.; Behavioral: Tobacco Quit Line Program; 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.
Experimental: Reactive group Participant will contact the research study staff to initiate the program.	Drug: Nicotine Patch; 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.; Behavioral: Tobacco Quit Line Program; 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.

Outcome Measures

Primary Outcome Measures

1. Continuous Abstinence [Measured at Year 1]

   No cigarette smoking since two weeks after the target quit date.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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

Exclusion Criteria:

• Known allergy or sensitivity to nicotine replacement therapy

• No telephone

• Inability to understand consent procedures

• Basic Military Trainee

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Tennessee Health Science Center	Memphis	Tennessee	United States	38105
2	Wilford Hall Medical Center	Lackland Air Force Base	Texas	United States	78236

Sponsors and Collaborators

• University of Tennessee
• National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: 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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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
• 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.
• 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.
• 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.
• Cronan TA, Conway TL, Hervig LK. Evaluation of smoking interventions in recruit training. Mil Med. 1989 Jul;154(7):371-5.
• 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
• 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: Smoking in DoD occupied buildings and facilities., in, Washington, DC, Department of Defense, 1977, p Instruction No. 6015.6018
• Department of Defense: Tobacco use prevention strategic plan., in, Washington, D.C., Department of Defense, 1999
• 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. Review. Erratum in: JAMA. 2005 Jan 19;293(3):298. Erratum in: JAMA. 2005 Jan 19;293(3):293-4.
• 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

• Responsible Party: University of Tennessee
• ClinicalTrials.gov Identifier: NCT00632411
• Other Study ID Numbers: 524; R18HL053478-07A2
• First Posted: Mar 10, 2008
• Last Update Posted: Mar 14, 2018
• Last Verified: Sep 1, 2016

• Additional relevant MeSH terms: Nicotine

Study Results

Participant Flow

Arm/Group Title	Proactive Group	Reactive Group
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	649	649
COMPLETED	489	473
NOT COMPLETED	160	176

Baseline Characteristics

Arm/Group Title	Proactive Group	Reactive Group	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	649	649	1298
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	649 100%	649 100%	1298 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.59 (13.65)	39.42 (13.82)	39.50 (13.73)
Sex: Female, Male (Count of Participants)
Female	291 44.8%	271 41.8%	562 43.3%
Male	358 55.2%	378 58.2%	736 56.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	63 9.7%	61 9.4%	124 9.6%
Not Hispanic or Latino	585 90.1%	588 90.6%	1173 90.4%
Unknown or Not Reported	1 0.2%	0 0%	1 0.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	6 0.9%	8 1.2%	14 1.1%
Asian	7 1.1%	10 1.5%	17 1.3%
Native Hawaiian or Other Pacific Islander	13 2%	5 0.8%	18 1.4%
Black or African American	85 13.1%	75 11.6%	160 12.3%
White	493 76%	509 78.4%	1002 77.2%
More than one race	24 3.7%	24 3.7%	48 3.7%
Unknown or Not Reported	21 3.2%	18 2.8%	39 3%
Region of Enrollment (participants) [Number]
United States	649 100%	649 100%	1298 100%

Outcome Measures

1. Primary Outcome

Title	Continuous Abstinence
Description	No cigarette smoking since two weeks after the target quit date.
Time Frame	Measured at Year 1

Outcome Measure Data

Analysis Population Description

Participants

Arm/Group Title	Proactive Group	Reactive Group
Arm/Group Description	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.	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.
Measure Participants	521	529
Count of Participants [Participants]	173 26.7%	136 21%

Adverse Events

Time Frame	1 year
Arm/Group Title	Proactive Group		Reactive Group
Arm/Group Description	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.		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.
All Cause Mortality
	Proactive Group		Reactive Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Proactive Group		Reactive Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/649 (2.5%)		6/649 (0.9%)
Surgical and medical procedures
Hospitalization	16/649 (2.5%)	16	6/649 (0.9%)	6
Other (Not Including Serious) Adverse Events
	Proactive Group		Reactive Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	307/649 (47.3%)		98/649 (15.1%)
Cardiac disorders
Increased Heart Rate/Heart Palpitations	4/649 (0.6%)	4	2/649 (0.3%)	2
Elevated Blood Pressure	1/649 (0.2%)	1	1/649 (0.2%)	1
Ear and labyrinth disorders
Ringing in Ears	1/649 (0.2%)	1	1/649 (0.2%)	1
General disorders
Headache	14/649 (2.2%)	14	4/649 (0.6%)	4
Infections and infestations
Ear Infection	1/649 (0.2%)	1	1/649 (0.2%)	1
Injury, poisoning and procedural complications
Skin Rash	88/649 (13.6%)	88	26/649 (4%)	26
Sleep Disturbance	64/649 (9.9%)	64	19/649 (2.9%)	19
Stomach illness/Nausea/Diarrhea	30/649 (4.6%)	30	14/649 (2.2%)	14
Pain/Joint Pain/Muscle Aches/ Back Pain	23/649 (3.5%)	23	6/649 (0.9%)	6
Injury: knee/foot	4/649 (0.6%)	4	0/649 (0%)	0
Metabolism and nutrition disorders
Fatigue/Lethargy	5/649 (0.8%)	5	5/649 (0.8%)	5
Psychiatric disorders
Anxiety/Irritability	7/649 (1.1%)	7	2/649 (0.3%)	2
Renal and urinary disorders
Hernia	4/649 (0.6%)	4	0/649 (0%)	0
Urinary Tract Infection, Bladder problems	2/649 (0.3%)	2	1/649 (0.2%)	1
Respiratory, thoracic and mediastinal disorders
Respiratory illness/ Sinus/ Sore throat/ Cold/Flu/Seasonal allergies	55/649 (8.5%)	55	13/649 (2%)	13
Skin and subcutaneous tissue disorders
Skin biopsy	2/649 (0.3%)	2	0/649 (0%)	0
Surgical and medical procedures
Gall bladder surgery	1/649 (0.2%)	1	2/649 (0.3%)	2
Tooth extraction	1/649 (0.2%)	1	1/649 (0.2%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.