Evaluating an Innovative Tobacco Treatment Approach for Veterans in Substance Use Treatment

NCT07809854 | Not Yet Recruiting Phase 4 FDA Drug

• 2 other identifiers: NURA-001-25F1IK2RD001577
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Cigarette Smoking; Veterans

Keywords

Cigarette Smoking; Clinical Trial; Substance-Related Disorders; Veterans

Outcome Measures

Primary Outcomes (1)

• Treatment Engagement

  Rates of self-reported use of nicotine replacement therapy and attending at least one counseling session

  At the end of 4 month treatment

Secondary Outcomes (1)

• 24h Quit Attempt

  At the end of 4 month treatment

Study Arms (2)

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.

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.

Drug: Cessation Treatment Nicotine Replacement Therapy (NRT); Behavioral: Cessation Treatment Counseling

Interventions

Healthy Changes Nicotine Replacement Therapy (NRT) DRUG

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).

Also known as: Nicorette

Co-STOP

Cessation Treatment Counseling BEHAVIORAL

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.

Co-STOP; Standard Care

Healthy Changes Counseling BEHAVIORAL

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.

Co-STOP

Cessation Treatment Nicotine Replacement Therapy (NRT) DRUG

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.

Also known as: Nicorette, NicoDerm

Co-STOP; Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of Wisconsin, Madison: collaborator

Study Sites (1)

William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, 53705-2254, United States

Location

MeSH Terms

Conditions

Cigarette Smoking; Substance-Related Disorders

Interventions

Nicotine Chewing Gum; Nicotine

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Chewing Gum; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Tobacco Use Cessation Devices; Therapeutics; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Jennifer M. Betts, PhD

  William S. Middleton Memorial Veterans Hospital, Madison, WI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer M Betts, PhD

CONTACT

(608) 280-7084; jennifer.betts@va.gov

Jessica M Cook, PhD

CONTACT

(608) 256-1901; Jessica.Cook2@va.gov

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Only the outcome assessors will be blinded to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to one of two treatment groups: (1) Co-STOP or (2) Standard Care

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 9, 2026
• Study Start (Estimated): April 1, 2027
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): September 30, 2031
• Last Updated: September 14, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)