Trial Outcomes & Findings for Tailored Tobacco Quitline for Rural Veterans (NCT NCT01592695)
NCT ID: NCT01592695
Last Updated: 2019-08-02
Results Overview
Participants' impressions of and satisfaction with the intervention will be assessed by interview at the end of treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
63 participants
Primary outcome timeframe
End of treatment (seven weeks after baseline)
Results posted on
2019-08-02
Participant Flow
Participant milestones
| Measure |
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.
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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.
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|---|---|---|
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Overall Study
STARTED
|
31
|
32
|
|
Overall Study
COMPLETED
|
23
|
28
|
|
Overall Study
NOT COMPLETED
|
8
|
4
|
Reasons for withdrawal
| Measure |
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.
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|---|---|---|
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Overall Study
Lost to Follow-up
|
8
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4
|
Baseline Characteristics
Tailored Tobacco Quitline for Rural Veterans
Baseline characteristics by cohort
| Measure |
Tailored Intervention Group
n=31 Participants
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
n=32 Participants
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.
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Total
n=63 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
55.1 years
STANDARD_DEVIATION 11.5 • n=5 Participants
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58.5 years
STANDARD_DEVIATION 8.8 • n=7 Participants
|
56.8 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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31 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
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Nicotine dependence
|
5.6 units on a scale
STANDARD_DEVIATION 2.3 • n=5 Participants
|
5.7 units on a scale
STANDARD_DEVIATION 2.1 • n=7 Participants
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5.7 units on a scale
STANDARD_DEVIATION 2.2 • n=5 Participants
|
|
Cigarettes smoked per day
|
22.3 cigarettes/day
STANDARD_DEVIATION 10.3 • n=5 Participants
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27.2 cigarettes/day
STANDARD_DEVIATION 25.7 • n=7 Participants
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24.7 cigarettes/day
STANDARD_DEVIATION 19.4 • n=5 Participants
|
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Prior quit attempts lasting at least 24 hours
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6.6 quit attempts
STANDARD_DEVIATION 8.1 • n=5 Participants
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9.4 quit attempts
STANDARD_DEVIATION 19.6 • n=7 Participants
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8.0 quit attempts
STANDARD_DEVIATION 15.0 • n=5 Participants
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Readiness to quit smoking
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6.8 units on a scale
STANDARD_DEVIATION 1.1 • n=5 Participants
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6.5 units on a scale
STANDARD_DEVIATION 1.3 • n=7 Participants
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6.6 units on a scale
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
Age of smoking initiation
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16.7 years
STANDARD_DEVIATION 3.4 • n=5 Participants
|
15.8 years
STANDARD_DEVIATION 2.8 • n=7 Participants
|
16.2 years
STANDARD_DEVIATION 3.1 • n=5 Participants
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PRIMARY outcome
Timeframe: End of treatment (seven weeks after baseline)Population: Participants who completed treatment satisfaction items on three-month follow-up
Participants' impressions of and satisfaction with the intervention will be assessed by interview at the end of treatment.
Outcome measures
| Measure |
Tailored Intervention Group
n=23 Participants
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
n=14 Participants
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.
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|---|---|---|
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Treatment Satisfaction
Liked that treatment was delivered by phone
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21 Participants
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10 Participants
|
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Treatment Satisfaction
Found treatment very or extremely useful
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17 Participants
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6 Participants
|
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Treatment Satisfaction
Found medication to be very or extremely useful
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16 Participants
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7 Participants
|
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Treatment Satisfaction
Found treatment to be very or extremely convenient
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16 Participants
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9 Participants
|
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Treatment Satisfaction
Found treatment to be very or extremely difficult
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5 Participants
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5 Participants
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SECONDARY outcome
Timeframe: Six-month follow-upPopulation: 7-day point prevalence abstinence at 6 months. Those with missing data treated as smokers (penalized imputation).
At the six-month follow-up contact, participants will be questioned regarding self-reported tobacco use over the past seven days (point prevalence abstinence).
Outcome measures
| Measure |
Tailored Intervention Group
n=31 Participants
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
n=32 Participants
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.
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|---|---|---|
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Number of Participants Abstinent From Tobacco Use
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9 Participants
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9 Participants
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SECONDARY outcome
Timeframe: Six-month follow-upPopulation: 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.
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.
Outcome measures
| Measure |
Tailored Intervention Group
n=2 Participants
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
n=4 Participants
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.
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|---|---|---|
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Alcohol Use
|
9.5 Drinks consumed per day
Standard Deviation 0.7
|
2.8 Drinks consumed per day
Standard Deviation 3.2
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SECONDARY outcome
Timeframe: Six-month follow-upPopulation: 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.
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.
Outcome measures
| Measure |
Tailored Intervention Group
n=13 Participants
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
n=16 Participants
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.
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|---|---|---|
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Depressive Symptoms
|
7.0 units on a scale
Standard Deviation 5.4
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3.9 units on a scale
Standard Deviation 2.7
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SECONDARY outcome
Timeframe: Six-month follow-upPopulation: 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.
Self-reported body weight.
Outcome measures
| Measure |
Tailored Intervention Group
n=6 Participants
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
n=9 Participants
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.
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|---|---|---|
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Body Weight
|
214.0 Pounds
Standard Deviation 38.1
|
228.2 Pounds
Standard Deviation 45.5
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SECONDARY outcome
Timeframe: 6 months after study initiationPopulation: Total number of participants randomized to each treatment condition.
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.
Outcome measures
| Measure |
Tailored Intervention Group
n=31 Participants
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
n=32 Participants
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.
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|---|---|---|
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Enrollment Rate
|
31 Participants
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32 Participants
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SECONDARY outcome
Timeframe: End of treatment (seven weeks after baseline)Population: Participants assigned to the tailored intervention condition who completed the intervention calls.
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.
Outcome measures
| Measure |
Tailored Intervention Group
n=31 Participants
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.
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|---|---|---|
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Retention
|
16 Participants
|
—
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SECONDARY outcome
Timeframe: End of treatment (seven weeks after baseline)Population: Attendance rate (number of counseling calls completed out of 6) among those assigned to the tailored intervention condition.
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.
Outcome measures
| Measure |
Tailored Intervention Group
n=31 Participants
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.
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|---|---|---|
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Treatment Attendance
|
4.0 Calls
Interval 0.0 to 6.0
|
—
|
Adverse Events
Tailored Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Standard of Care Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place