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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Robert C. Klesges, University of Tennessee
ClinicalTrials.gov Identifier:
NCT00632411
First received: March 6, 2008
Last updated: July 18, 2014
Last verified: July 2014
  Purpose

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 Intervention
Smoking
Smoking Cessation
Drug: Nicotine Patch
Behavioral: Tobacco Quit Line Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of a Smoking Quit Line in the Military

Resource links provided by NLM:


Further study details as provided by University of Tennessee:

Primary Outcome Measures:
  • Efficacy of tobacco quit line to improve smoking cessation rates [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]

Enrollment: 1298
Study Start Date: April 2008
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00632411

Locations
United States, Tennessee
University of Tennessee Health Science Center
Memphis, Tennessee, United States, 38105
United States, Texas
Wilford Hall Medical Center
Lackland AFB, Texas, United States, 78236
Sponsors and Collaborators
University of Tennessee
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 - Clinical and Translational Science Institute
Principal Investigator: Gerald W. Talcott, Ph.D. Colonel (Ret.) Wilford Hall Medical Center; University of Tennessee Health Science Center
  More Information

Publications:
Responsible Party: Robert C. Klesges, Professor, University of Tennessee
ClinicalTrials.gov Identifier: NCT00632411     History of Changes
Other Study ID Numbers: 524, R18HL053478-07A2
Study First Received: March 6, 2008
Last Updated: July 18, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Smoking
Habits
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014