Tobacco CessationPhase 2/3Stepped CareNCT04501016
A Stepped Care Approach to Treating Tobacco Use in Rural Veterans
A Phase 2/3 study testing Tailored behavioral counseling and Tobacco cessation pharmacotherapy in people with Tobacco Cessation, run by Iowa City Veterans Affairs Medical Center at 1 site in United States.
Trial summary
Tobacco use remains prevalent among Veterans. Although effective smoking cessation interventions exist, long-term term quit rates remain sub-optimal. The project will investigate the feasibility of a stepped care approach to treating tobacco use that includes enhancements based on initial response to treatment to… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Cessation
- What is being tested?
- Tailored behavioral counseling and Tobacco cessation pharmacotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2020to Sep 2023
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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
- Use tobacco (cigarettes, smokeless tobacco, pipes, cigars, hookah) on a daily basis
- Be willing to make a quit attempt in the next 30 days
- Able to provide informed consent
- Have access to a telephone
- Have a stable residence,
Who cannot join
- Planning to move within the next 6 months
- Terminal illness
- Unstable psychiatric disorder (e.g., acute psychosis)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Iowa City VA Healthcare System
Iowa City, Iowa, 52246
About this study
Tobacco use remains prevalent among Veterans. Although effective smoking cessation interventions exist, long-term term quit rates remain sub-optimal. The project will investigate the feasibility of a stepped care approach to treating tobacco use that includes enhancements based on initial response to treatment to augment the investigators' existing tailored tobacco treatment intervention.
Read the detailed description
Rural tobacco users (cigarette smokers, smokeless tobacco users, and users of other forms of tobacco) from the Iowa City VA Health Care System will be proactively recruited using information obtained from the electronic medical record. All participants will receive the investigators' tailored, six session smoking cessation intervention developed over a series of projects funded by ORH. This includes a counseling protocol tailored to tobacco users' individual needs and associated risk factors as well as pharmacotherapy selected using shared decision making. Participants who are unable to quit initially will be provided with enhanced counseling based on self-monitoring and scheduled reduced smoking. Those who are able to quit using tobacco during the initial treatment phase will be given an extended, four-session counseling protocol that incorporates new content based on established interventions from positive psychology in an effort to reduce relapse.
- Conditions
- Tobacco Cessation
- Being tested
- Tailored behavioral counseling, Tobacco cessation pharmacotherapy
- Medical subject headings
- Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored behavioral counselingBehavioural
Participants will initially receive a six-session telephone intervention. Standard cognitive behavioral treatment strategies will be included. Participants will be screened for elevated depressive symptoms, risky alcohol use, and concerns about weight and and offered supplemental behavioral counseling related to these issues as appropriate. Those that are unable to quit tobacco initially will receive an enhanced, four-session counseling module focused on reduced scheduled smoking. Those who do quit tobacco use initially will receive four sessions of extended counseling based on positive psychology intervention strategies.
Tobacco cessation pharmacotherapyDrug
Pharmacotherapy will be selected based on medical and psychiatric history and potential interactions with other current medications combined with shared decision making. Options will include nicotine gum (2 and 4 mg), nicotine lozenge (2 and 4 mg), nicotine patch (7, 14, and 21 mg), bupropion (150 mg twice daily) and varenicline (1 mg twice daily). Monotherapy and combination therapy options will be provided.
| Study group | Role | What they receive |
|---|---|---|
| Tailored Intervention | Experimental | Tailored behavioral counseling combined with tobacco cessation pharmacotherapy. Receives: Behavioral: Tailored behavioral counseling; Drug: Tobacco cessation pharmacotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tobacco cessation
7-day point prevalence tobacco cessation
Measured: 6 months
Secondary outcomes (2)
Tobacco cessation
7-day point prevalence tobacco cessation
Measured: 3 months
Salivary cotinine levels (in ng/ml)
Salivary cotinine
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study startSep 2020 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco CessationStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All tobacco users will receive a tailored pharmacological and behavioral intervention. The specific counseling protocol will vary depending upon their response to treatment and initial success with quitting.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
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 Vander Weg, PhD, Principal investigator, Iowa City VA Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04501016
- Sponsor's protocol ID
- IowacityVAMC
- Acronym
- Stepped Care
- Status last verified
- Aug 2020
- First submitted
- 29 Jul 2020
- Last updated
- 6 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Stepped Care Approach to Treating Tobacco Use in Rural Veterans
- ClinicalTrials.gov ID
- NCT04501016
- Acronym / sponsor ID
- Stepped Care / IowacityVAMC
- Conditions
- Tobacco Cessation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Iowa City Veterans Affairs Medical CenterUS federal agency
- Collaborators
- US Department of Veterans Affairs
- Study start
- Sep 2020 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 6 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tobacco use remains prevalent among Veterans. Although effective smoking cessation interventions exist, long-term term quit rates remain sub-optimal. The project will investigate the feasibility of a stepped care approach to treating tobacco use that includes enhancements based on initial response to treatment to augment the investigators' existing tailored tobacco treatment intervention.
Detailed description
Rural tobacco users (cigarette smokers, smokeless tobacco users, and users of other forms of tobacco) from the Iowa City VA Health Care System will be proactively recruited using information obtained from the electronic medical record. All participants will receive the investigators' tailored, six session smoking cessation intervention developed over a series of projects funded by ORH. This includes a counseling protocol tailored to tobacco users' individual needs and associated risk factors as well as pharmacotherapy selected using shared decision making. Participants who are unable to quit initially will be provided with enhanced counseling based on self-monitoring and scheduled reduced smoking. Those who are able to quit using tobacco during the initial treatment phase will be given an extended, four-session counseling protocol that incorporates new content based on established interventions from positive psychology in an effort to reduce relapse.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All tobacco users will receive a tailored pharmacological and behavioral intervention. The specific counseling protocol will vary depending upon their response to treatment and initial success with quitting.
| Arm | Type | Receives |
|---|---|---|
| Tailored Intervention | Experimental | Behavioral: Tailored behavioral counseling, Drug: Tobacco cessation pharmacotherapyTailored behavioral counseling combined with tobacco cessation pharmacotherapy. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Use tobacco (cigarettes, smokeless tobacco, pipes, cigars, hookah) on a daily basis
- Be willing to make a quit attempt in the next 30 days
- Able to provide informed consent
- Have access to a telephone
- Have a stable residence,
Key exclusion criteria (3 listed)
- Planning to move within the next 6 months
- Terminal illness
- Unstable psychiatric disorder (e.g., acute psychosis)
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 |
|---|---|---|
| Tailored behavioral counselingParticipants will initially receive a six-session telephone intervention. Standard cognitive behavioral treatment strategies will be included. Participants will be screened for elevated depressive symptoms, risky alcohol use, and concerns about weight and and offered supplemental behavioral counseling related to these issues as appropriate. Those that are unable to quit tobacco initially will receive an enhanced, four-session counseling module focused on reduced scheduled smoking. Those who do quit tobacco use initially will receive four sessions of extended counseling based on positive psychology intervention strategies. | Behavioural | Tailored Intervention |
| Tobacco cessation pharmacotherapyPharmacotherapy will be selected based on medical and psychiatric history and potential interactions with other current medications combined with shared decision making. Options will include nicotine gum (2 and 4 mg), nicotine lozenge (2 and 4 mg), nicotine patch (7, 14, and 21 mg), bupropion (150 mg twice daily) and varenicline (1 mg twice daily). Monotherapy and combination therapy options will be provided. | Drug | Tailored Intervention |
Primary outcome
Tobacco cessation
Time frame: 6 months
7-day point prevalence tobacco cessation
2 secondary outcomes
Tobacco cessation
Time frame: 3 months
Salivary cotinine levels (in ng/ml)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Individual participant dataSharing planned: No
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Impacto 2.0: Mobile Smoking Cessation Across Texas
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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.
Mark Vander Weg, PhD principal investigator
Iowa City VA Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tailored behavioral counseling and Tobacco cessation pharmacotherapy in people with Tobacco Cessation, 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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 6 Aug 2020. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Theresa Morano, MS (319-338-0581 ext. 63-7663, theresa.morano@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tobacco cessation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2020.