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Tailored Tobacco Quitline for Rural Veterans

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01592695
First Posted: May 7, 2012
Last Update Posted: July 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
VA Office of Research and Development
Information provided by (Responsible Party):
Mark Vander Weg, University of Iowa
Results First Submitted: April 14, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Cigarette Smoking
Interventions: Drug: Nicotine replacement therapy - transdermal nicotine patch
Behavioral: Tailored behavioral intervention
Behavioral: Tobacco quit line referral
Drug: Nicotine replacement therapy - nicotine gum
Drug: Nicotine replacement therapy - nicotine lozenge
Drug: Bupropion Sustained Release
Drug: Varenicline
Drug: Combination pharmacotherapy - transdermal nicotine patch + nicotine gum
Drug: Combination pharmacotherapy - transdermal nicotine patch + nicotine lozenge
Drug: Combination pharmacotherapy - transdermal nicotine patch + bupropion
Behavioral: Alcohol use risk reduction
Behavioral: Behavioral activation for the treatment of depression
Behavioral: Behavioral management of post-cessation weight gain

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Tailored Intervention Group

Participants will receive a combined behavioral and pharmacological intervention.

Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.

Tailored behavioral intervention: Participants will receive a standard six session cognitive behavioral intervention for smoking cessation combined with supplemental treatment modules treatment modules to address common issues associated with cigarette smoking based on individual need and preference. Individual treatment models address alcohol risk reduction, elevated depressive symptoms, and concerns about weight gain.

Enhanced Standard of Care Group

Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quit line along with pharmacotherapy to assist with smoking cessation.

Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.

Tobacco quit line referral: Participants assigned to this condition will receive a referral to their state tobacco quit line. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence.


Participant Flow:   Overall Study
    Tailored Intervention Group   Enhanced Standard of Care Group
STARTED   31   32 
COMPLETED   23   28 
NOT COMPLETED   8   4 
Lost to Follow-up                8                4 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Tailored Intervention Group

Participants will receive a combined behavioral and pharmacological intervention.

Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.

Enhanced Standard of Care Group

Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quit line along with pharmacotherapy to assist with smoking cessation.

Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.

Tobacco quit line referral: Participants assigned to this condition will receive a referral to their state tobacco quit line. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence.

Total Total of all reporting groups

Baseline Measures
   Tailored Intervention Group   Enhanced Standard of Care Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 31   32   63 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      26  83.9%      29  90.6%      55  87.3% 
>=65 years      5  16.1%      3   9.4%      8  12.7% 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.1  (11.5)   58.5  (8.8)   56.8  (10.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      3   9.7%      5  15.6%      8  12.7% 
Male      28  90.3%      27  84.4%      55  87.3% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   31   32   63 
Nicotine dependence [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 5.6  (2.3)   5.7  (2.1)   5.7  (2.2) 
[1] Possible scores range from 0 to 11. Higher scores indicate greater levels of nicotine dependence.
Cigarettes smoked per day 
[Units: Cigarettes/day]
Mean (Standard Deviation)
 22.3  (10.3)   27.2  (25.7)   24.7  (19.4) 
Prior quit attempts lasting at least 24 hours 
[Units: Quit attempts]
Mean (Standard Deviation)
 6.6  (8.1)   9.4  (19.6)   8.0  (15.0) 
Readiness to quit smoking [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 6.8  (1.1)   6.5  (1.3)   6.6  (1.2) 
[1] Scores range from 1 to 10, with higher scores indicating greater readiness to quit smoking.
Age of smoking initiation 
[Units: Years]
Mean (Standard Deviation)
 16.7  (3.4)   15.8  (2.8)   16.2  (3.1) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Treatment Satisfaction   [ Time Frame: End of treatment (seven weeks after baseline) ]

2.  Secondary:   Number of Participants Abstinent From Tobacco Use   [ Time Frame: Six-month follow-up ]

3.  Secondary:   Alcohol Use   [ Time Frame: Six-month follow-up ]

4.  Secondary:   Depressive Symptoms   [ Time Frame: Six-month follow-up ]

5.  Secondary:   Body Weight   [ Time Frame: Six-month follow-up ]

6.  Secondary:   Enrollment Rate   [ Time Frame: 6 months after study initiation ]

7.  Secondary:   Retention   [ Time Frame: End of treatment (seven weeks after baseline) ]

8.  Secondary:   Treatment Attendance   [ Time Frame: End of treatment (seven weeks after baseline) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.


Results Point of Contact:  
Name/Title: Mark Vander Weg, PhD
Organization: University of Iowa
phone: 319-338-0581 ext 7717
e-mail: mark-vanderweg@uiowa.edu


Publications of Results:

Responsible Party: Mark Vander Weg, University of Iowa
ClinicalTrials.gov Identifier: NCT01592695     History of Changes
Other Study ID Numbers: 201203712
First Submitted: April 11, 2012
First Posted: May 7, 2012
Results First Submitted: April 14, 2017
Results First Posted: July 19, 2017
Last Update Posted: July 19, 2017