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

Conditions

• Cigarette Smoking
• Veterans

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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).
• 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.
• 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.
• 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.

Study Details

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.

Key Dates

First listed

Sep 9, 2026

Start date

Apr 1, 2027

Status verified

Sep 2026

Primary completion

Apr 1, 2030

Completion

Sep 30, 2031

Study Design

Enrollment

112 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.
• 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.

Primary Outcome Measure

Treatment Engagement [ Time Frame: At the end of 4 month treatment ]

Central Contacts

• Jennifer M Betts, PhD
  (608) 280-7084
  [email protected]
• Jessica M Cook, PhD
  (608) 256-1901
  [email protected]

Locations (1)

Find similar trials in Madison, WI

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