Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 55 of 1594 for:    veterans affairs medical center

Tailored Tobacco Quitline for Rural Veterans

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.
 
ClinicalTrials.gov Identifier: NCT01592695
Recruitment Status : Completed
First Posted : May 7, 2012
Results First Posted : July 19, 2017
Last Update Posted : August 2, 2019
Sponsor:
Collaborator:
US Department of Veterans Affairs
Information provided by (Responsible Party):
Mark Vander Weg, Iowa City Veterans Affairs Medical Center

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
Enrollment 63
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tailored Intervention Group Enhanced Standard of Care Group
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 31 32
Completed 23 28
Not Completed 8 4
Reason Not Completed
Lost to Follow-up             8             4
Arm/Group Title Tailored Intervention Group Enhanced Standard of Care Group Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 31 32 63
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 32 participants 63 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, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants 32 participants 63 participants
55.1  (11.5) 58.5  (8.8) 56.8  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 32 participants 63 participants
Female
3
   9.7%
5
  15.6%
8
  12.7%
Male
28
  90.3%
27
  84.4%
55
  87.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 31 participants 32 participants 63 participants
31
 100.0%
32
 100.0%
63
 100.0%
Nicotine dependence   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 31 participants 32 participants 63 participants
5.6  (2.3) 5.7  (2.1) 5.7  (2.2)
[1]
Measure Description: Possible scores range from 0 to 11. Higher scores indicate greater levels of nicotine dependence.
Cigarettes smoked per day  
Mean (Standard Deviation)
Unit of measure:  Cigarettes/day
Number Analyzed 31 participants 32 participants 63 participants
22.3  (10.3) 27.2  (25.7) 24.7  (19.4)
Prior quit attempts lasting at least 24 hours  
Mean (Standard Deviation)
Unit of measure:  Quit attempts
Number Analyzed 31 participants 32 participants 63 participants
6.6  (8.1) 9.4  (19.6) 8.0  (15.0)
Readiness to quit smoking   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 31 participants 32 participants 63 participants
6.8  (1.1) 6.5  (1.3) 6.6  (1.2)
[1]
Measure Description: Scores range from 1 to 10, with higher scores indicating greater readiness to quit smoking.
Age of smoking initiation  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants 32 participants 63 participants
16.7  (3.4) 15.8  (2.8) 16.2  (3.1)
1.Primary Outcome
Title Treatment Satisfaction
Hide Description Participants' impressions of and satisfaction with the intervention will be assessed by interview at the end of treatment.
Time Frame End of treatment (seven weeks after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed treatment satisfaction items on three-month follow-up
Arm/Group Title Tailored Intervention Group Enhanced Standard of Care Group
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 23 14
Measure Type: Count of Participants
Unit of Measure: Participants
Found treatment very or extremely useful Number Analyzed 23 participants 13 participants
17
  73.9%
6
  46.2%
Found medication to be very or extremely useful Number Analyzed 21 participants 13 participants
16
  76.2%
7
  53.8%
Found treatment to be very or extremely convenient Number Analyzed 22 participants 12 participants
16
  72.7%
9
  75.0%
Found treatment to be very or extremely difficult Number Analyzed 20 participants 11 participants
5
  25.0%
5
  45.5%
Liked that treatment was delivered by phone Number Analyzed 23 participants 14 participants
21
  91.3%
10
  71.4%
2.Secondary Outcome
Title Number of Participants Abstinent From Tobacco Use
Hide Description At the six-month follow-up contact, participants will be questioned regarding self-reported tobacco use over the past seven days (point prevalence abstinence).
Time Frame Six-month follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
7-day point prevalence abstinence at 6 months. Those with missing data treated as smokers (penalized imputation).
Arm/Group Title Tailored Intervention Group Enhanced Standard of Care Group
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 31 32
Measure Type: Count of Participants
Unit of Measure: Participants
9
  29.0%
9
  28.1%
3.Secondary Outcome
Title Alcohol Use
Hide Description Alcohol use during the previous seven days will be assessed among those receiving the risky alcohol use treatment module and those in the quitline referral condition who would have been eligible for the intervention if assigned to the tailored treatment group.
Time Frame Six-month follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the tailored intervention group who received the alcohol intervention and those in the enhanced standard of care group who would have been eligible for the alcohol intervention if they had been assigned to the tailored intervention group.
Arm/Group Title Tailored Intervention Group Enhanced Standard of Care Group
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 2 4
Mean (Standard Deviation)
Unit of Measure: Drinks consumed per day
9.5  (0.7) 2.8  (3.2)
4.Secondary Outcome
Title Depressive Symptoms
Hide Description Depressive symptoms as measured using the Patient Health Questionnaire 9 (PHQ-9). Possible scores range from 0 to 27, with higher scores indicating greater levels of depressive symptoms.
Time Frame Six-month follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the tailored intervention group who receive the mood management module and those in the enhanced standard of care condition who would have been eligible for the mood management module if they had been assigned to the tailored intervention condition.
Arm/Group Title Tailored Intervention Group Enhanced Standard of Care Group
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 13 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.0  (5.4) 3.9  (2.7)
5.Secondary Outcome
Title Body Weight
Hide Description Self-reported body weight.
Time Frame Six-month follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Assessed among participants in the tailored intervention group who received the weight management module and those in the enhanced standard of care condition who would have been eligible for the weight management module if they had been assigned to the tailored intervention condition.
Arm/Group Title Tailored Intervention Group Enhanced Standard of Care Group
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 6 9
Mean (Standard Deviation)
Unit of Measure: Pounds
214.0  (38.1) 228.2  (45.5)
6.Secondary Outcome
Title Enrollment Rate
Hide Description The number of participants enrolled will be tracked as a measure of the feasibility of the intervention approached for the entire six-month recruitment period.
Time Frame 6 months after study initiation
Hide Outcome Measure Data
Hide Analysis Population Description
Total number of participants randomized to each treatment condition.
Arm/Group Title Tailored Intervention Group Enhanced Standard of Care Group
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 31 32
Measure Type: Count of Participants
Unit of Measure: Participants
31
 100.0%
32
 100.0%
7.Secondary Outcome
Title Retention
Hide Description The number of participants who remain in the study throughout the seven-week treatment period will be computed as an indicator of the feasibility of the treatment approach.
Time Frame End of treatment (seven weeks after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants assigned to the tailored intervention condition who completed the intervention calls.
Arm/Group Title Tailored Intervention Group
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 31
Measure Type: Count of Participants
Unit of Measure: Participants
16
  51.6%
8.Secondary Outcome
Title Treatment Attendance
Hide Description The number of treatment calls completed (out of six total) will be calculated for all participants in the Tailored Intervention group as an indicator of the feasibility of the treatment approach.
Time Frame End of treatment (seven weeks after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Attendance rate (number of counseling calls completed out of 6) among those assigned to the tailored intervention condition.
Arm/Group Title Tailored Intervention Group
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 31
Mean (Full Range)
Unit of Measure: Calls
4.0
(0 to 6)
Time Frame Six months
Adverse Event Reporting Description Data regarding adverse events were collected via self-report and information provided in patients' electronic medical record.
 
Arm/Group Title Tailored Intervention Group Enhanced Standard of Care Group
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Tailored Intervention Group Enhanced Standard of Care Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/32 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Tailored Intervention Group Enhanced Standard of Care Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/32 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tailored Intervention Group Enhanced Standard of Care Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/32 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Mark Vander Weg, PhD
Organization: University of Iowa
Phone: 319-338-0581 ext 7717
EMail: mark-vanderweg@uiowa.edu
Layout table for additonal information
Responsible Party: Mark Vander Weg, Iowa City Veterans Affairs Medical Center
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: August 2, 2019