← Back to Search

Nicotine Replacement Therapy

Smoking Cessation Outreach Methods for Quitting Smoking

N/A
Waitlist Available
Led By Danielle E McCarthy, PhD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 and 18 months after study enrollment
Awards & highlights

Study Summary

This trial will compare two methods of helping patients quit smoking: one with more frequent and tailored outreach, and one with standard outreach. 10 primary care clinics will take part. Patients will be in the study for 18 months.

Who is the study for?
The BREATHE 2 study is for adults over 18 who smoke and have visited participating primary care clinics in the last 1-3 years. They must be on a smoking registry, speak English, and have a valid address. Those with invalid addresses or who opted out of the study are excluded.Check my eligibility
What is being tested?
This trial tests if more frequent outreach, varied outreach methods (like texts), and multiple treatment options help smokers quit better than standard approaches. Participants will experience this at certain clinics for up to 18 months.See study design
What are the potential side effects?
Possible side effects from treatments like nicotine replacement may include skin irritation from patches, sleep disturbances, headache, nausea, heart palpitations or dizziness.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 and 18 months after study enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 and 18 months after study enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Smoking treatment initiation within 12 months of enrollment
Secondary outcome measures
Conversion from current smoking to former smoking
Cost per quit
Cost per quit attempt
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Enhanced outreachExperimental Treatment6 Interventions
Quarterly outreach via letter and applicable patient-preferred modalities, including e-mail and/or text messaging, offering both standard person-to-person treatment options (quitline referral, primary care provider referral, cessation counseling and treatment in a randomized clinical trial) and self-guided, remote treatment options (mailed nicotine replacement therapy samples and/or facilitated enrollment in a Smokefree.gov texting program). Patients in clinics assigned to this arm will also have the option to initiate treatment by phone or online. Patients may also receive outreach calls from Tobacco Care Managers offering the person-to-person treatments at their health systems 1-30 days following a visit to a participating clinic.
Group II: Standard outreachActive Control3 Interventions
One mailed letter at study initiation outlining available person-to-person treatment options (quitline referral, primary care provider referral, cessation counseling and treatment in a randomized clinical trial) and how to initiate treatment by phone. Patients may also receive outreach calls from Tobacco Care Managers offering the person-to-person treatments at their health systems 1-30 days following a visit to a participating clinic.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotine replacement therapy sampling
2018
N/A
~1060

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,182 Previous Clinical Trials
3,154,387 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,920,667 Total Patients Enrolled
Danielle E McCarthy, PhDPrincipal InvestigatorUniversity of Wisconsin, Madison
1 Previous Clinical Trials
50 Total Patients Enrolled

Media Library

Nicotine replacement therapy sampling (Nicotine Replacement Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05683821 — N/A
Smoking Cessation Research Study Groups: Standard outreach, Enhanced outreach
Smoking Cessation Clinical Trial 2023: Nicotine replacement therapy sampling Highlights & Side Effects. Trial Name: NCT05683821 — N/A
Nicotine replacement therapy sampling (Nicotine Replacement Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05683821 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for recruitment into this trial currently?

"As the data on clinicaltrials.gov attests, this trial is not recruiting at present. Initially posted in July of 2023 and recently updated in late July that same year, it has yet to begin accepting patients. However, 185 other medical studies are currently enrolling participants."

Answered by AI

Who else is applying?

What site did they apply to?
University of Wisconsin Center for Tobacco Research and Intervention
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
BREATHE 2 Clinic Stop-Smoking Treatment Outreach Study
2023. "BREATHE 2 Clinic Stop-Smoking Treatment Outreach Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05683821.
~4643 spots leftby Oct 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top