Nicotine Replacement + Counseling for Smoking in Veterans

(Co-STOP Trial)

JM
JM
Overseen ByJessica M Cook, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human 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.12345

Why 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?

JM

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

I am medically able to use nicotine replacement therapy.
Not currently receiving smoking treatment
Not currently at high risk for suicide
See 3 more

Exclusion Criteria

Incarceration
I am not able to give informed and voluntary consent to join the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 4 months of nicotine replacement therapy and behavioral counseling as part of the Co-STOP program or standard care

16 weeks
5 counseling calls

Follow-up

Participants are monitored for treatment engagement and quit attempts after the treatment phase

4 weeks

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

Group I: Co-STOPExperimental Treatment4 Interventions
Group II: Standard CareActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

University of Wisconsin, Madison

Collaborator

Trials
1,249
Recruited
3,255,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/23152200/

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