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Tobacco Cessation Treatments for Tobacco Use (MESH Trial)
Phase 4
Waitlist Available
Led By Sarah M. Wilson, PhD
Research Sponsored by VA Office of Research and Development
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 post-treatment, approximately eight weeks after baseline visit
Awards & highlights
MESH Trial Summary
This trial will study whether a new treatment plan that includes personalized counseling, medications, and text messaging can help people quit smoking.
MESH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post-treatment, approximately eight weeks after baseline visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-treatment, approximately eight weeks after baseline visit
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants who report post-treatment satisfaction
Secondary outcome measures
Proportion of participants who completed treatment in the active treatment group
Therapist-rated treatment acceptability in active treatment group
Treatment attendance
MESH Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: MESHExperimental Treatment3 Interventions
Participants assigned to this group will receive a treatment that includes personalized smoking cessation facilitation meetings with cognitive-behavioral therapy, personalized smoking cessation pharmacotherapy, and personalized text messaging.
Group II: Best Practice Telehealth GroupActive Control3 Interventions
Participants assigned to this group will be referred to Quit Vet (VA's quitline for stopping tobacco) and SmokefreeVET (a free text messaging program to help you quit), and will receive information about getting quit medications.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Personalized Smoking Cessation Facilitation Meetings
2022
Completed Phase 4
~30
Personalized Smoking Cessation Pharmacotherapy
2022
Completed Phase 4
~30
Personalized Text Messaging Support
2022
Completed Phase 4
~30
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,573 Total Patients Enrolled
4 Trials studying Tobacco Use
5,004 Patients Enrolled for Tobacco Use
Sarah M. Wilson, PhDPrincipal InvestigatorDurham VA Medical Center, Durham, NC
1 Previous Clinical Trials
12 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are not currently using regular cigarettes or smokeless tobacco, but vaping is allowed.You smoke cigarettes, cigars, or use smokeless tobacco at least once a week.You smoke or use smokeless tobacco at least once a day.
Research Study Groups:
This trial has the following groups:- Group 1: MESH
- Group 2: Best Practice Telehealth Group
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Tobacco Use Patient Testimony for trial: Trial Name: NCT05277207 — Phase 4
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there currently an opportunity for participants to join this scientific experiment?
"Affirmative. According to the information on clinicaltrials.gov, this trial is currently recruiting individuals for participation; it was first published online on May 2nd 2022 and updated most recently on May 5th 2022. The study seeks 30 participants from one medical location."
Answered by AI
What is the highest possible number of participants in this research project?
"Affirmative. The information posted on clinicaltrials.gov reveals that this investigation is currently seeking participants, having first been advertised on May 2nd 2022 with an update made to the listing on May 5th 2022. 30 individuals are being recruited from a single site for enrolment in the trial."
Answered by AI
What potential detriments may occur from utilizing Personalized Smoking Cessation Pharmacotherapy?
"Our experts at Power have scored Personalized Smoking cessation Pharmacotherapy a 3, as it is in its fourth phase of clinical trials and has thus been approved for use."
Answered by AI
Who else is applying?
What state do they live in?
New York
Georgia
Florida
Other
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Durham VA Medical Center, Durham, NC
How many prior treatments have patients received?
2
0
Why did patients apply to this trial?
Always wanted to try paid clinical trails. I have not tried any drugs to quit smoking but not able to. I quit for few months and it urge starts again.
PatientReceived 1 prior treatment
I tried to quit smoking over 30 years and will be 50 years old just year and I need a change of thinking by reducing unhealthy habits and I need your help.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
how long is the screening?
PatientReceived no prior treatments
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