Cigarette SmokingPhase 2NCT01592695
Tailored Tobacco Quitline for Rural Veterans
A Phase 2 study testing Nicotine replacement therapy - transdermal nicotine patch, Tailored behavioral intervention and Tobacco quit line referral in people with Cigarette Smoking, run by Iowa City Veterans Affairs Medical Center at 1 site in United States.
Trial summary
The proposed work is designed to help increase access to tobacco cessation services among rural veterans and to develop more effective treatment services that better address comorbid issues commonly experienced by rural smokers. The objectives are: 1. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- Nicotine replacement therapy - transdermal nicotine patch, Tailored behavioral intervention and Tobacco quit line referral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Jun 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being a veteran
- 18 + years of age
- Smoke cigarettes on at least a daily basis
- Receive primary care from the Iowa City VAMC or Coralville Clinic
- Live in a non-metropolitan area (based on RUCA codes)
- Be willing to make a quit attempt in the next 30 days
Show all 9Show fewer
- Be capable of providing informed consent
- Have access to a telephone (land line or cell phone)
- Have a stable residence
Who cannot join
- Planning to move within the next 12 months
- Presence of a terminal illness
- Pregnancy
- Unstable psychiatric disorder (e.g., acute psychosis)
- Currently pregnant
- Incarcerated
- Institutionalized
Trial locations and contacts
1 site in 1 country.
United States1 site
Iowa City VA Health Care System
Iowa City, Iowa, 52246
About this study
Official title: Tailored Tobacco Cessation Program for Rural Veterans With Comorbid Depression, Alcoholism or Obesity
The proposed work is designed to help increase access to tobacco cessation services among rural veterans and to develop more effective treatment services that better address comorbid issues commonly experienced by rural smokers. The objectives are:
- Study the feasibility of an individually-tailored telephone intervention for rural smokers.
- Examine the impact of the intervention on tobacco use outcomes.
- Evaluate the effect of the intervention on issues commonly experienced by rural smokers including depressive symptoms, alcohol use, and weight gain.
Read the detailed description
Tobacco use remains the leading preventable cause of morbidity and mortality in our society. Results from epidemiologic studies indicate that tobacco use is especially elevated among those living in rural areas. Although interventions exist that are both effective and cost-effective, few rural smokers utilize them during any given quit attempt. A lack of local treatment resources, the travel distance required to obtain treatment, and a reduced tendency to visit primary care on a regular basis all appear to contribute to the lower levels of treatment for nicotine dependence in rural smokers.
Smokers frequently experience conditions and concerns that adversely impact their ability to quit smoking. Depression and risky alcohol use, both of which are prevalent among smokers, reduce the likelihood of successfully quitting smoking. Concern about gaining weight, a common consequence of quitting smoking, is also frequently cited by smokers as an important barrier to quitting. Therefore, in order to be most effective, tobacco cessation interventions will need to address these important issues. Presently, treatment for nicotine dependence, risky alcohol use, depression, and weight management is typically delivered separately and without optimal integration among providers, an approach which only serves to fragment care and increase the number of required visits, further reduce rural smokers' access to care.
In an effort to address these barriers, the current study will evaluate a telephone intervention for tobacco use that also addresses issues related to risky alcohol use, depressed mood, and postcessation weight gain based on each individual smoker's needs. Results will provide valuable information regarding the potential to more widely implement an individually-tailored telephone intervention for rural smokers.
- Conditions
- Cigarette Smoking
- Being tested
- Nicotine replacement therapy - transdermal nicotine patch, Tailored behavioral intervention, Tobacco quit line referral, Nicotine replacement therapy - nicotine gum, Nicotine replacement therapy - nicotine lozenge
- Keywords
- Nicotine dependence, Smoking cessation, Telehealth, Alcohol use, Depression, Body weight
- Medical subject headings
- Cigarette Smoking, Tobacco Use Disorder, Smoking Cessation, Alcohol Drinking, Depression, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine replacement therapy - transdermal nicotine patchDrug
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Tailored behavioral interventionBehavioural
Participants will receive a standard six session cognitive behavioral intervention for smoking cessation combined with supplemental treatment modules based on individual need and preference.
Tobacco quit line referralBehavioural
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.
Nicotine replacement therapy - nicotine gumDrug
Medication selection will be determined based on individual participant preferences, medical history, and contraindications
Nicotine replacement therapy - nicotine lozengeDrug
Medication selection will be determined based on individual participant preferences, medical history, and contraindications
Bupropion Sustained ReleaseDrug
Also called Zyban
Medication selection will be determined based on individual participant preferences, medical history, and contraindications
VareniclineDrug
Also called Chantix
Medication selection will be determined based on individual participant preferences, medical history, and contraindications
Combination pharmacotherapy - transdermal nicotine patch + nicotine gumDrug
Medication selection will be determined based on individual participant preferences, medical history, and contraindications
Combination pharmacotherapy - transdermal nicotine patch + nicotine lozengeDrug
Medication selection will be determined based on individual participant preferences, medical history, and contraindications
Combination pharmacotherapy - transdermal nicotine patch + bupropionDrug
Medication selection will be determined based on individual participant preferences, medical history, and contraindications
Alcohol use risk reductionBehavioural
Also called Risky alcohol use, Harm reduction
Participants engaging in risky alcohol use may receive this six-session telephone-based behavioral intervention for reducing alcohol use.
Behavioral activation for the treatment of depressionBehavioural
Also called Depression
Participants with elevated depressive symptoms may receive this six-session telephone-based behavioral activation intervention.
Behavioral management of post-cessation weight gainBehavioural
Also called Weight management
Participants with concerns about gaining weight after quitting smoking may receive this six-session telephone-based behavioral self-management intervention designed to help attenuate post-cessation weight gain.
| Study group | Role | What they receive |
|---|---|---|
| Tailored Intervention Group | Experimental | Participants will receive a combined behavioral and pharmacological intervention. The behavioral component will consist of a six-session cognitive behavioral telephone intervention combined with supplemental treatment modules to address common issues associated with cigarette smoking. Receives: Drug: Nicotine replacement therapy - transdermal nicotine patch; Behavioral: Tailored behavioral intervention; 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 |
| Enhanced Standard of Care Group | Active comparator | 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. Receives: Drug: Nicotine replacement therapy - transdermal nicotine patch; 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Satisfaction
Participants' impressions of and satisfaction with the intervention will be assessed by interview at the end of treatment.
Measured: End of treatment (seven weeks after baseline)
Secondary outcomes (7)
Number of Participants Abstinent From Tobacco Use
At the six-month follow-up contact, participants will be questioned regarding self-reported tobacco use over the past seven days (point prevalence abstinence).
Measured: Six-month follow-up
Alcohol Use
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.
Measured: Six-month follow-up
Depressive Symptoms
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.
Measured: Six-month follow-up
Body Weight
Self-reported body weight.
Measured: Six-month follow-up
Enrollment Rate
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.
Measured: 6 months after study initiation
Retention
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.
Measured: End of treatment (seven weeks after baseline)
Treatment Attendance
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.
Measured: End of treatment (seven weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iowa City Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Principal investigator, Mark Vander Weg, Iowa City Veterans Affairs Medical Center
- Investigators
- Mark VanderWeg, PhD, Principal investigator, VRHRC-CR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01592695
- Sponsor's protocol ID
- 201203712
- Status last verified
- Jul 2019
- First submitted
- 11 Apr 2012
- Last updated
- 2 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Vander Weg MW, Cozad AJ, Howren MB, Cretzmeyer M, Scherubel M, Turvey C, Grant KM, Abrams TE, Katz DA. An individually-tailored smoking cessation intervention for rural Veterans: a pilot randomized trial. BMC Public Health. 2016 Aug 17;16(1):811. doi: 10.1186/s12889-016-3493-z.
PubMed 27535024Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
PubMed 37142273
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Tobacco Cessation Program for Rural Veterans With Comorbid Depression, Alcoholism or Obesity
- ClinicalTrials.gov ID
- NCT01592695
- Acronym / sponsor ID
- 201203712
- Conditions
- Cigarette Smoking
- Keywords
- Nicotine dependence, Smoking cessation, Telehealth, Alcohol use, Depression, Body weight
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Iowa City Veterans Affairs Medical CenterUS federal agency
- Collaborators
- US Department of Veterans Affairs
- Study start
- Jun 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 7 May 2012 (estimated)
- Results
- Posted 19 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed work is designed to help increase access to tobacco cessation services among rural veterans and to develop more effective treatment services that better address comorbid issues commonly experienced by rural smokers. The objectives are:
- Study the feasibility of an individually-tailored telephone intervention for rural smokers.
- Examine the impact of the intervention on tobacco use outcomes.
- Evaluate the effect of the intervention on issues commonly experienced by rural smokers including depressive symptoms, alcohol use, and weight gain.
Detailed description
Tobacco use remains the leading preventable cause of morbidity and mortality in our society. Results from epidemiologic studies indicate that tobacco use is especially elevated among those living in rural areas. Although interventions exist that are both effective and cost-effective, few rural smokers utilize them during any given quit attempt. A lack of local treatment resources, the travel distance required to obtain treatment, and a reduced tendency to visit primary care on a regular basis all appear to contribute to the lower levels of treatment for nicotine dependence in rural smokers.
Smokers frequently experience conditions and concerns that adversely impact their ability to quit smoking. Depression and risky alcohol use, both of which are prevalent among smokers, reduce the likelihood of successfully quitting smoking. Concern about gaining weight, a common consequence of quitting smoking, is also frequently cited by smokers as an important barrier to quitting. Therefore, in order to be most effective, tobacco cessation interventions will need to address these important issues. Presently, treatment for nicotine dependence, risky alcohol use, depression, and weight management is typically delivered separately and without optimal integration among providers, an approach which only serves to fragment care and increase the number of required visits, further reduce rural smokers' access to care.
In an effort to address these barriers, the current study will evaluate a telephone intervention for tobacco use that also addresses issues related to risky alcohol use, depressed mood, and postcessation weight gain based on each individual smoker's needs. Results will provide valuable information regarding the potential to more widely implement an individually-tailored telephone intervention for rural smokers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tailored Intervention Group | Experimental | Drug: Nicotine replacement therapy - transdermal nicotine patch, Behavioral: Tailored behavioral intervention, 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 gainParticipants will receive a combined behavioral and pharmacological intervention. The behavioral component will consist of a six-session cognitive behavioral telephone intervention combined with supplemental treatment modules to address common issues associated with cigarette smoking. |
| Enhanced Standard of Care Group | Active comparator | Drug: Nicotine replacement therapy - transdermal nicotine patch, 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 + bupropionParticipants 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Being a veteran
- 18 + years of age
- Smoke cigarettes on at least a daily basis
- Receive primary care from the Iowa City VAMC or Coralville Clinic
- Live in a non-metropolitan area (based on RUCA codes)
Key exclusion criteria (7 listed)
- Planning to move within the next 12 months
- Presence of a terminal illness
- Pregnancy
- Unstable psychiatric disorder (e.g., acute psychosis)
- Currently pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine replacement therapy - transdermal nicotine patchMedication selection will be determined based on individual participant preferences, medical history, and contraindications. | Drug | Enhanced Standard of Care Group, Tailored Intervention Group |
| Tailored behavioral interventionParticipants will receive a standard six session cognitive behavioral intervention for smoking cessation combined with supplemental treatment modules based on individual need and preference. | Behavioural | Tailored Intervention Group |
| Tobacco quit line referralParticipants 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. | Behavioural | Enhanced Standard of Care Group |
| Nicotine replacement therapy - nicotine gumMedication selection will be determined based on individual participant preferences, medical history, and contraindications | Drug | Enhanced Standard of Care Group, Tailored Intervention Group |
| Nicotine replacement therapy - nicotine lozengeMedication selection will be determined based on individual participant preferences, medical history, and contraindications | Drug | Enhanced Standard of Care Group, Tailored Intervention Group |
| Bupropion Sustained ReleaseAlso: ZybanMedication selection will be determined based on individual participant preferences, medical history, and contraindications | Drug | Enhanced Standard of Care Group, Tailored Intervention Group |
| VareniclineAlso: ChantixMedication selection will be determined based on individual participant preferences, medical history, and contraindications | Drug | Enhanced Standard of Care Group, Tailored Intervention Group |
| Combination pharmacotherapy - transdermal nicotine patch + nicotine gumMedication selection will be determined based on individual participant preferences, medical history, and contraindications | Drug | Enhanced Standard of Care Group, Tailored Intervention Group |
| Combination pharmacotherapy - transdermal nicotine patch + nicotine lozengeMedication selection will be determined based on individual participant preferences, medical history, and contraindications | Drug | Enhanced Standard of Care Group, Tailored Intervention Group |
| Combination pharmacotherapy - transdermal nicotine patch + bupropionMedication selection will be determined based on individual participant preferences, medical history, and contraindications | Drug | Enhanced Standard of Care Group, Tailored Intervention Group |
| Alcohol use risk reductionAlso: Risky alcohol use, Harm reductionParticipants engaging in risky alcohol use may receive this six-session telephone-based behavioral intervention for reducing alcohol use. | Behavioural | Tailored Intervention Group |
| Behavioral activation for the treatment of depressionAlso: DepressionParticipants with elevated depressive symptoms may receive this six-session telephone-based behavioral activation intervention. | Behavioural | Tailored Intervention Group |
| Behavioral management of post-cessation weight gainAlso: Weight managementParticipants with concerns about gaining weight after quitting smoking may receive this six-session telephone-based behavioral self-management intervention designed to help attenuate post-cessation weight gain. | Behavioural | Tailored Intervention Group |
Primary outcome
Treatment Satisfaction
Time frame: End of treatment (seven weeks after baseline)
Participants' impressions of and satisfaction with the intervention will be assessed by interview at the end of treatment.
7 secondary outcomes
Number of Participants Abstinent From Tobacco Use
Time frame: Six-month follow-up
Alcohol Use
Time frame: Six-month follow-up
Depressive Symptoms
Time frame: Six-month follow-up
Body Weight
Time frame: Six-month follow-up
Enrollment Rate
Time frame: 6 months after study initiation
Retention
Time frame: End of treatment (seven weeks after baseline)
Treatment Attendance
Time frame: End of treatment (seven weeks after baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27535024Vander Weg MW, Cozad AJ, Howren MB, Cretzmeyer M, Scherubel M, Turvey C, Grant KM, Abrams TE, Katz DA. An individually-tailored smoking cessation intervention for rural Veterans: a pilot randomized trial. BMC Public Health. 2016 Aug 17;16(1):811. doi: 10.1186/s12889-016-3493-z.
- Derived from this study: PubMed 37142273Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark VanderWeg, PhD principal investigator
VRHRC-CR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nicotine replacement therapy - transdermal nicotine patch, Tailored behavioral intervention and Tobacco quit line referral in people with Cigarette Smoking, run by Iowa City Veterans Affairs Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Satisfaction (time frame: End of treatment (seven weeks after baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01592695, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2019.