Nicotine Replacement + Counseling for Smoking in Veterans
(Co-STOP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new program designed to assist Veterans struggling with both substance use and smoking. The program, called Co-STOP, combines nicotine replacement therapy (such as patches or gum) with counseling to determine if it encourages more people to attempt quitting smoking compared to the usual treatment. Participants may qualify if they smoke at least one cigarette daily, are in VA outpatient substance use treatment, and haven't recently tried smoking treatments. The research seeks to discover better ways to support Veterans in quitting smoking, potentially improving their overall health. As a Phase 4 trial, this study involves an FDA-approved treatment and aims to understand how it can benefit more patients.
What is the safety track record for these treatments?
Previous studies have shown that nicotine replacement therapy (NRT) is safe for those trying to quit smoking. The FDA has approved it, and doctors often recommend it as the first treatment option. Most people experience only mild side effects, such as skin irritation, headaches, or nausea. Importantly, NRT does not carry the harmful health effects associated with smoking cigarettes.
Research shows that combining NRT with counseling can improve the chances of quitting. Counseling provides support and strategies to manage cravings and withdrawal symptoms. Health experts often recommend this combination for effectively quitting smoking.
In summary, NRT, especially when combined with counseling, is well-tolerated and considered safe. It offers a promising way to help Veterans quit smoking while reducing health risks.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about this trial because it explores a flexible approach to smoking cessation for veterans, incorporating Nicotine Replacement Therapy (NRT) with counseling without requiring an immediate commitment to quit. Unlike standard care, which primarily focuses on immediate cessation, this method allows participants to set manageable goals and use NRT to gradually reduce smoking, creating a more personalized and potentially less intimidating path to quitting. This approach not only targets the physical addiction but also addresses the behavioral aspects of smoking, offering a comprehensive support system that might increase the chances of long-term success.
What evidence suggests that this trial's treatments could be effective for smoking in Veterans with substance use disorders?
Research has shown that nicotine replacement therapy (NRT) combined with counseling can significantly aid smokers in quitting. In this trial, participants in the Co-STOP arm will receive Healthy Changes treatment, which includes NRT and counseling to support their smoking cessation goals. Studies indicate that NRT can increase the chances of quitting by 50 to 70%. Veterans who received proactive support reported higher success rates in remaining smoke-free for a year. Additionally, using multiple types of NRT yields better results than using just one. Overall, NRT, particularly when paired with counseling, offers a strong opportunity for smokers to quit successfully.678910
Who Is on the Research Team?
Jennifer M. Betts, PhD
Principal Investigator
William S. Middleton Memorial Veterans Hospital, Madison, WI
Are You a Good Fit for This Trial?
This trial is for veterans who are currently in outpatient treatment for substance use disorders and also smoke cigarettes. Participants should be willing to try quitting smoking as part of their ongoing care.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 4 months of nicotine replacement therapy and behavioral counseling as part of the Co-STOP program or standard care
Follow-up
Participants are monitored for treatment engagement and quit attempts after the treatment phase
What Are the Treatments Tested in This Trial?
Interventions
- Cessation Treatment Counseling
- Cessation Treatment Nicotine Replacement Therapy (NRT)
- Healthy Changes Counseling
- Healthy Changes Nicotine Replacement Therapy (NRT)
Trial Overview
The study compares a new program called Co-STOP, which combines counseling and nicotine replacement therapy (NRT), with standard tobacco treatment methods to see which helps veterans quit smoking more effectively.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor
University of Wisconsin, Madison
Collaborator
Citations
Nicotine replacement therapy for smoking cessation
NRTs increase the rate of quitting by 50 to 70%, regardless of setting. The effectiveness of NRT appears to be largely independent of the ...
2.
tobaccopreventioncessation.com
tobaccopreventioncessation.com/The-effectiveness-of-nicotine-replacement-therapy-on-oral-smokeless-tobacco-cessation,208023,0,2.htmlThe effectiveness of nicotine replacement therapy on oral ...
Several studies have been conducted to test the effectiveness of NRTs, with mixed results. A previous systematic review found that nicotine ...
3.
tobaccoinduceddiseases.org
tobaccoinduceddiseases.org/Comparative-assessment-of-outcomes-of-smoking-cessation-ntherapies-and-role-of-free,136422,0,2.htmlComparative assessment of outcomes of smoking ...
About 9% of the patients failed to quit smoking initially but succeeded for a while after the first intervention at the cessation clinic. The relapse rate after ...
Proactive Outreach Helps Veterans with PTSD Overcome ...
For the primary abstinence outcome, Veterans randomized to proactive outreach reported higher rates of 7-day point prevalence abstinence at 12 months in both ...
Nicotine replacement therapy for smoking cessation (Review)
The main outcome measure was abstinence from smoking after at least six months of follow up. ... The effectiveness of NRT appears to be largely independent of the ...
Quit Tobacco With Counseling & Medication. Veteran Support
How To Quit. The research is clear—you have your best chance at quitting tobacco when you get behavioral counseling and use cessation medication.
Social support intervention for enhancing smoking treatment ...
Veteran follow-up survey response rates were 81.5 %. Intervention participants reported a higher rate of cessation medication use (57.1 % vs.
New approach to smoking cessation boosts quit rates for ...
Smoking cessation treatment that is made part of mental health care for veterans with post traumatic stress disorder improves quit rates, ...
Tobacco cessation strategies in military personnel: A meta- ...
Behavioural counseling and nicotine replacement therapy are most effective. • Veterans show lower quit success than active-duty military personnel.
Military Service Members and Veterans | For Specific Groups
Smoking cessation counseling is available at all VA medical centers, At least two quit attempts per year, and at least four tobacco cessation counseling ...
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