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

ConditionsCigarette Smoking Veterans

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Unable to give informed, voluntary consent to participate

Incarceration

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

112 Participants

are divided into 2 treatment groups

Group A: Co-STOPExperimental treatment 4 interventions

Group B: Standard CareActive comparator 2 interventions

Trial outcomes

Primary outcomes

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

Secondary outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Office of Research and Development

Lead sponsor

University of Wisconsin, Madison

Collaborator

Source ClinicalTrials.gov

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