Evaluating an Innovative Tobacco Treatment Approach for Veterans in Substance Use Treatment (Co-STOP)

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. We 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cigarette Smoking; Veterans
• Intervention / Treatment: Drug: Healthy Changes Nicotine Replacement Therapy (NRT); Drug: Cessation Treatment Nicotine Replacement Therapy (NRT); Behavioral: Cessation Treatment Counseling; Behavioral: Healthy Changes Counseling

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. We 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 Type: Interventional
• Enrollment (Estimated): 112
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jessica M Cook, PhD; Phone Number: (608) 256-1901; Email: Jessica.Cook2@va.gov
• Study Contact Backup: Name: Jennifer M Betts, PhD; Phone Number: (608) 280-7084; Email: jennifer.betts@va.gov

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705-2254
      • William S. Middleton Memorial Veterans Hospital, Madison, WI
      • Contact: Elana G Brubaker, MSW BS; Phone Number: 17854 (608) 256-1901; Email: elana.brubaker@va.gov
      • Principal Investigator: Jennifer M. Betts, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Unable to give informed, voluntary consent to participate
• Incarceration

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Co-STOP; 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.	Drug: Healthy Changes Nicotine Replacement Therapy (NRT); 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).; Other Names: Nicorette; Drug: Cessation Treatment Nicotine Replacement Therapy (NRT); 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.; Other Names: Nicortte, Nicoderm; Behavioral: Cessation Treatment Counseling; 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.; Behavioral: Healthy Changes Counseling; 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.
Active Comparator: Standard Care; 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.	Drug: Cessation Treatment Nicotine Replacement Therapy (NRT); 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.; Other Names: Nicortte, Nicoderm; Behavioral: Cessation Treatment Counseling; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Engagement	Self-reported use of nicotine replacement therapy and attending at least one counseling session	At the end of 4 month treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24h Quit Attempt	Self-reported quit attempt lasting at least 24 hours during the study	At the end of 4 month treatment

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: University of Wisconsin, Madison
• Investigators: Principal Investigator: Jennifer M. Betts, PhD, William S. Middleton Memorial Veterans Hospital, Madison, WI

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2027
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): September 30, 2031

Study Registration Dates

• First Submitted: September 3, 2026
• First Submitted That Met QC Criteria: September 3, 2026
• First Posted (Actual): September 9, 2026

Study Record Updates

• Last Update Posted (Actual): September 9, 2026
• Last Update Submitted That Met QC Criteria: September 3, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Veterans; Clinical Trial; Substance-Related Disorders; Cigarette Smoking
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Behavior; Smoking; Tobacco Smoking; Tobacco Use; Substance-Related Disorders; Cigarette Smoking; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Carbohydrates; Alkaloids; Polymers; Macromolecular Substances; Polysaccharides; Biopolymers; Plant Gums; Candy; Solanaceous Alkaloids; Chewing Gum; Tobacco Use Cessation Devices; Nicotine; Nicotine Chewing Gum
• Other Study ID Numbers: NURA-001-25F; 1IK2RD001577 (Other Grant/Funding Number: Department of Veterans Affairs)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Deidentified dataset will be shared upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No