Cigarette SmokingPhase 4Co-STOPNCT07809854
Evaluating an Innovative Tobacco Treatment Approach for Veterans in Substance Use Treatment
A Phase 4 study testing Healthy Changes Nicotine Replacement Therapy (NRT), Cessation Treatment Nicotine Replacement Therapy (NRT) and Cessation Treatment Counseling in people with Cigarette Smoking and Veterans, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Veterans with substance use disorders smoke at extraordinarily high rates and have high rates of smoking-related death and disease. It is essential to provide tobacco treatment for Veterans with substance use disorders, but there are unfortunately low rates of smoking treatment engagement within the VA for those with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cigarette Smoking, Veterans
- What is being tested?
- Healthy Changes Nicotine Replacement Therapy (NRT), Cessation Treatment Nicotine Replacement Therapy (NRT) and Cessation Treatment Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2027to 30 Sep 2031
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Smoke at least one cigarette per day
- Be engaged in VA outpatient substance use treatment for at least one month
- Be medically eligible to use Nicotine Replacement Therapy (NRT)
- Not currently receiving smoking treatment
- Not currently at high risk for suicide
- Have an email address
Who cannot join
- Unable to give informed, voluntary consent to participate
- Incarceration
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
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, 53705-2254
Elana G Brubaker, MSW BS, (608) 256-1901 ext. 17854, elana.brubaker@va.gov
Jennifer M. Betts, PhD
About this study
Official title: Evaluating an Innovative Tobacco Treatment Approach for Veterans in Substance Use Disorder Treatment
Veterans with substance use disorders smoke at extraordinarily high rates and have high rates of smoking-related death and disease. It is essential to provide tobacco treatment for Veterans with substance use disorders, but there are unfortunately low rates of smoking treatment engagement within the VA for those with substance use disorders. The goal of this project is to generate preliminary evidence for a smoking intervention program called "Concurrent Substance and Tobacco Outpatient Program" or Co-STOP. Co-STOP aims to increase tobacco treatment use and effectiveness for Veterans in outpatient substance use treatment. The investigators hypothesize that Co-STOP, relative to standard tobacco treatment, will increase tobacco treatment use and quit attempts. This research will help the VA develop effective strategies to promote smoking treatment use and abstinence in Veterans with substance use disorders who smoke, thereby improving rates of morbidity and mortality in Veterans with substance use disorders.
Read the detailed description
This project will generate knowledge about strategies to increase smoking treatment engagement in Veterans with substance use disorders, a group that suffers disproportionately from smoking-related disease and death. This project will This project will evaluate the acceptability, feasibility, and preliminary efficacy of the Co-STOP program relative to standard cessation treatment offered at the VA. Co-STOP is an intervention designed to make tobacco treatment part of routine care for Veterans in substance use treatment and thereby enhance tobacco treatment use and quit attempts. Co-STOP offers evidence-based counseling and nicotine replacement therapy for smoking cessation as well as smoking reduction or changes if Veterans are not willing to quit. In Co-STOP, treatment is provided unless the Veteran declines, and makes tobacco treatment the default during substance use treatment. It is expected that Enhanced Chronic Care will increase treatment use and smoking abstinence relative to Standard Care.
This project will randomize N=112 Veterans receiving VA outpatient SUD care who smoke daily in a 1:1 ratio to Co-STOP or SC in a pilot randomized controlled trial (RCT). Co-STOP participants will be informed that they will be provided with evidence-based smoking treatment, which does not require a commitment to quit, as part of their SUD care, unless they opt-out. Co-STOP participants who do not opt out will receive 4 months of nicotine replacement therapy (NRT) and five behavioral counseling calls to support making 'healthy changes' or quitting smoking. SC participants will be offered entry into standard VA cessation treatment. Outcomes will be assessed over 4-months post-study entry. The investigators hypothesize that relative to SC, Co-STOP will increase smoking treatment use (i.e., use of NRT + counseling) and the likelihood of making a quit attempt.
- Conditions
- Cigarette Smoking, Veterans
- Being tested
- Healthy Changes Nicotine Replacement Therapy (NRT), Cessation Treatment Nicotine Replacement Therapy (NRT), Cessation Treatment Counseling, Healthy Changes Counseling
- Keywords
- Cigarette Smoking, Clinical Trial, Substance-Related Disorders, Veterans
- Medical subject headings
- Cigarette Smoking, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Changes Nicotine Replacement Therapy (NRT)Drug
Also called Nicorette
All participants in Co-STOP will receive their choice of nicotine mini-lozenge or gum for 4 months, unless they decline or start Cessation Treatment instead. If <30 min to first cigarette of the day then 4mg mini-lozenges/gum will be prescribed, and if ≥30 min to first cigarette of the day then 2-mg mini-lozenges/gum will be prescribed. Participants will be encouraged to use NRT in place of smoking (5-15 pieces/day).
Cessation Treatment Nicotine Replacement Therapy (NRT)Drug
Also called Nicorette, NicoDerm
If a participant enters Cessation Treatment, they will receive combination NRT (patch with participant choice of mini-lozenge or gum). Nicotine patch dosing, which will begin on the TQD, will be will be consistent with medication labeling; i.e., if smoking >10 cigarettes/day= starting at 21-mg; if smoking ≤10 cigarettes/day = starting at 14-mg nicotine patches. Similarly, dosing for nicotine mini-lozenge/gum: <30 min to 1st cig/day starting at 4mg every 1-2 hours; if ≥30 min to 1st cig/day, then starting at 2mg every 1-2 hours.
Cessation Treatment CounselingBehavioural
All participants who enter cessation treatment will receive five, 15-20 minute counseling calls over 16 weeks. Calls will be scheduled at approximately 1-week pre-target quit day (TQD), 1-day post TQD, and three flexible sessions up to week 16. Prior to quitting, the study counselor will reinforce reasons for quitting, discuss past quit experiences, and develop a quit day plan. Post-quit sessions will include coping with cravings, identifying high-risk situations (e.g., co-use with other substances), developing behavioral plans for high-risk situations, and a plan to manage a lapse/relapse.
Healthy Changes CounselingBehavioural
All participants in Co-STOP will receive counseling calls for Healthy Changes Counseling unless they choose to enter Cessation Treatment or decline. Participants will receive five, 15-20 minute counseling phone calls over 16 weeks. During counseling calls, the study counselor will work with participants to develop smoking change goals, including smoking reduction, changing smoking contexts, and using NRT. Counseling sessions will explore participants' motivations for changing their tobacco use and address pragmatic issues such as co-use with other substances, work contexts, smoking policies, and habits that interfere with desired changes. Counseling will emphasize competence and self-efficacy, both of which will be linked to the practice of smoking change skills.
| Study group | Role | What they receive |
|---|---|---|
| Co-STOP | Experimental | Co-STOP participants will receive evidence-based smoking treatment, that does not require a commitment to quit, as routine part of their SUD care unless they decline treatment. This will include 4 months of counseling and NRT to support the smoking change goal on which they would like to work. All participants in the Co-STOP condition will receive Healthy Changes treatment, which focuses on making manageable changes to smoking, unless they choose to make a quit attempt (or decline treatment). If they choose to make a quit attempt, they will receive Cessation Treatment. Receives: Drug: Healthy Changes Nicotine Replacement Therapy (NRT); Drug: Cessation Treatment Nicotine Replacement Therapy (NRT); Behavioral: Cessation Treatment Counseling; Behavioral: Healthy Changes Counseling |
| Standard Care | Active comparator | Participants in Standard Care will be asked if they are interested in quitting smoking in the next month, and if so, they will be offered Cessation Treatment, which is consistent with existing VA standard care. Receives: Drug: Cessation Treatment Nicotine Replacement Therapy (NRT); Behavioral: Cessation Treatment Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Engagement
Rates of self-reported use of nicotine replacement therapy and attending at least one counseling session
Measured: At the end of 4 month treatment
Secondary outcomes (1)
24h Quit Attempt
Rates of self-reported quit attempt lasting at least 24 hours during the study
Measured: At the end of 4 month treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start1 Apr 2027 (estimated)
- Primary completion1 Apr 2030 (estimated)
- Study completion30 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to one of two treatment groups: (1) Co-STOP or (2) Standard Care
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- University of Wisconsin, Madison
- Responsible party
- Sponsor
- Investigators
- Jennifer M. Betts, PhD, Principal investigator, William S. Middleton Memorial Veterans Hospital, Madison, WI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07809854
- Sponsor's protocol ID
- NURA-001-25F
- Other IDs
- 1IK2RD001577
- Acronym
- Co-STOP
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Deidentified dataset will be shared upon request.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating an Innovative Tobacco Treatment Approach for Veterans in Substance Use Disorder Treatment
- ClinicalTrials.gov ID
- NCT07809854
- Acronym / sponsor ID
- Co-STOP / NURA-001-25F
- Conditions
- Cigarette Smoking, Veterans
- Keywords
- Cigarette Smoking, Clinical Trial, Substance-Related Disorders, Veterans
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- University of Wisconsin, Madison
- Study start
- 1 Apr 2027 (estimated)
- Primary completion
- 1 Apr 2030 (estimated)
- Study completion
- 30 Sep 2031 (estimated)
- First posted
- 9 Sep 2026 (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.
Veterans with substance use disorders smoke at extraordinarily high rates and have high rates of smoking-related death and disease. It is essential to provide tobacco treatment for Veterans with substance use disorders, but there are unfortunately low rates of smoking treatment engagement within the VA for those with substance use disorders. The goal of this project is to generate preliminary evidence for a smoking intervention program called "Concurrent Substance and Tobacco Outpatient Program" or Co-STOP. Co-STOP aims to increase tobacco treatment use and effectiveness for Veterans in outpatient substance use treatment. The investigators hypothesize that Co-STOP, relative to standard tobacco treatment, will increase tobacco treatment use and quit attempts. This research will help the VA develop effective strategies to promote smoking treatment use and abstinence in Veterans with substance use disorders who smoke, thereby improving rates of morbidity and mortality in Veterans with substance use disorders.
Detailed description
This project will generate knowledge about strategies to increase smoking treatment engagement in Veterans with substance use disorders, a group that suffers disproportionately from smoking-related disease and death. This project will This project will evaluate the acceptability, feasibility, and preliminary efficacy of the Co-STOP program relative to standard cessation treatment offered at the VA. Co-STOP is an intervention designed to make tobacco treatment part of routine care for Veterans in substance use treatment and thereby enhance tobacco treatment use and quit attempts. Co-STOP offers evidence-based counseling and nicotine replacement therapy for smoking cessation as well as smoking reduction or changes if Veterans are not willing to quit. In Co-STOP, treatment is provided unless the Veteran declines, and makes tobacco treatment the default during substance use treatment. It is expected that Enhanced Chronic Care will increase treatment use and smoking abstinence relative to Standard Care.
This project will randomize N=112 Veterans receiving VA outpatient SUD care who smoke daily in a 1:1 ratio to Co-STOP or SC in a pilot randomized controlled trial (RCT). Co-STOP participants will be informed that they will be provided with evidence-based smoking treatment, which does not require a commitment to quit, as part of their SUD care, unless they opt-out. Co-STOP participants who do not opt out will receive 4 months of nicotine replacement therapy (NRT) and five behavioral counseling calls to support making 'healthy changes' or quitting smoking. SC participants will be offered entry into standard VA cessation treatment. Outcomes will be assessed over 4-months post-study entry. The investigators hypothesize that relative to SC, Co-STOP will increase smoking treatment use (i.e., use of NRT + counseling) and the likelihood of making a quit attempt.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to one of two treatment groups: (1) Co-STOP or (2) Standard Care
| Arm | Type | Receives |
|---|---|---|
| Co-STOP | Experimental | Drug: Healthy Changes Nicotine Replacement Therapy (NRT), Drug: Cessation Treatment Nicotine Replacement Therapy (NRT), Behavioral: Cessation Treatment Counseling, Behavioral: Healthy Changes CounselingCo-STOP participants will receive evidence-based smoking treatment, that does not require a commitment to quit, as routine part of their SUD care unless they decline treatment. This will include 4 months of counseling and NRT to support the smoking change goal on which they would like to work. All participants in the Co-STOP condition will receive Healthy Changes treatment, which focuses on making manageable changes to smoking, unless they choose to make a quit attempt (or decline treatment). If they choose to make a quit attempt, they will receive Cessation Treatment. |
| Standard Care | Active comparator | Drug: Cessation Treatment Nicotine Replacement Therapy (NRT), Behavioral: Cessation Treatment CounselingParticipants in Standard Care will be asked if they are interested in quitting smoking in the next month, and if so, they will be offered Cessation Treatment, which is consistent with existing VA standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Smoke at least one cigarette per day
- Be engaged in VA outpatient substance use treatment for at least one month
- Be medically eligible to use Nicotine Replacement Therapy (NRT)
- Not currently receiving smoking treatment
- Not currently at high risk for suicide
Key exclusion criteria (2 listed)
- Unable to give informed, voluntary consent to participate
- Incarceration
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 |
|---|---|---|
| Healthy Changes Nicotine Replacement Therapy (NRT)Also: NicoretteAll participants in Co-STOP will receive their choice of nicotine mini-lozenge or gum for 4 months, unless they decline or start Cessation Treatment instead. If <30 min to first cigarette of the day then 4mg mini-lozenges/gum will be prescribed, and if ≥30 min to first cigarette of the day then 2-mg mini-lozenges/gum will be prescribed. Participants will be encouraged to use NRT in place of smoking (5-15 pieces/day). | Drug | Co-STOP |
| Cessation Treatment Nicotine Replacement Therapy (NRT)Also: Nicorette, NicoDermIf a participant enters Cessation Treatment, they will receive combination NRT (patch with participant choice of mini-lozenge or gum). Nicotine patch dosing, which will begin on the TQD, will be will be consistent with medication labeling; i.e., if smoking >10 cigarettes/day= starting at 21-mg; if smoking ≤10 cigarettes/day = starting at 14-mg nicotine patches. Similarly, dosing for nicotine mini-lozenge/gum: <30 min to 1st cig/day starting at 4mg every 1-2 hours; if ≥30 min to 1st cig/day, then starting at 2mg every 1-2 hours. | Drug | Co-STOP, Standard Care |
| Cessation Treatment CounselingAll participants who enter cessation treatment will receive five, 15-20 minute counseling calls over 16 weeks. Calls will be scheduled at approximately 1-week pre-target quit day (TQD), 1-day post TQD, and three flexible sessions up to week 16. Prior to quitting, the study counselor will reinforce reasons for quitting, discuss past quit experiences, and develop a quit day plan. Post-quit sessions will include coping with cravings, identifying high-risk situations (e.g., co-use with other substances), developing behavioral plans for high-risk situations, and a plan to manage a lapse/relapse. | Behavioural | Co-STOP, Standard Care |
| Healthy Changes CounselingAll participants in Co-STOP will receive counseling calls for Healthy Changes Counseling unless they choose to enter Cessation Treatment or decline. Participants will receive five, 15-20 minute counseling phone calls over 16 weeks. During counseling calls, the study counselor will work with participants to develop smoking change goals, including smoking reduction, changing smoking contexts, and using NRT. Counseling sessions will explore participants' motivations for changing their tobacco use and address pragmatic issues such as co-use with other substances, work contexts, smoking policies, and habits that interfere with desired changes. Counseling will emphasize competence and self-efficacy, both of which will be linked to the practice of smoking change skills. | Behavioural | Co-STOP |
Primary outcome
Treatment Engagement
Time frame: At the end of 4 month treatment
Rates of self-reported use of nicotine replacement therapy and attending at least one counseling session
1 secondary outcome
24h Quit Attempt
Time frame: At the end of 4 month treatment
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 14 Sep 2026.
- Individual participant dataSharing planned: No. Deidentified dataset will be shared upon request.
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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.
Jennifer M. Betts, PhD principal investigator
William S. Middleton Memorial Veterans Hospital, Madison, WI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Healthy Changes Nicotine Replacement Therapy (NRT), Cessation Treatment Nicotine Replacement Therapy (NRT) and Cessation Treatment Counseling in people with Cigarette Smoking and Veterans, run by VA Office of Research and Development 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 6 inclusion and 2 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 14 Sep 2026. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Jennifer M Betts, PhD ((608) 280-7084, jennifer.betts@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Engagement (time frame: At the end of 4 month treatment). 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 14 Sep 2026.