A Phase 4 interventional study of Healthy Changes Nicotine Replacement Therapy (NRT) and Cessation Treatment Nicotine Replacement Therapy (NRT) in Cigarette Smoking and Veterans, sponsored by VA Office of Research and Development. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by VA Office of Research and Development · Phase 4, Interventional, and 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.
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.
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This study's planned enrollment of 112 is above the median of 96 across 406 interventional studies indexed under Cigarette Smoking.
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Exclusion Criteria:
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
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
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
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
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.
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.
Treatment Engagement
Rates of self-reported use of nicotine replacement therapy and attending at least one counseling session
Time frame: At the end of 4 month treatment
24h Quit Attempt
Rates of self-reported quit attempt lasting at least 24 hours during the study
Time frame: At the end of 4 month treatment
Plan to share: No — Deidentified dataset will be shared upon request.
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Studies of the drug tested here: Nicotine Chewing Gum
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