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Nicotine Replacement Therapy
Free Nicotine Replacement Therapy for Smoking (FreSH Trial)
Phase 2
Waitlist Available
Led By Sandra Japuntich
Research Sponsored by Hennepin Healthcare Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Smokes at least 1 combustible cigarette per day on at least 25 days of the month
≥ 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post baseline
Awards & highlights
FreSH Trial Summary
This trial tests if giving free nicotine replacement therapy at dental visits helps more people quit smoking than giving a gift of same value.
Who is the study for?
This trial is for adults over 18 who smoke at least one cigarette daily on most days of the month. Participants must own a smartphone with internet and cannot join if they are pregnant, breastfeeding, had a recent heart attack or stroke, or used tobacco cessation meds recently.Check my eligibility
What is being tested?
The study compares the effectiveness of free nicotine replacement therapy (like lozenges and patches) given during dental visits versus receiving an electric toothbrush to see which helps more people quit smoking.See study design
What are the potential side effects?
Nicotine replacement products may cause mouth irritation, sleep disturbances, digestive discomfort, headache, dizziness, and skin irritation where the patch is applied.
FreSH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I smoke at least one cigarette daily for most of the month.
Select...
I am 18 years old or older.
FreSH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months post baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
7-day biochemically confirmed point prevalence abstinence
Secondary outcome measures
24-hour intentional quit attempts
7-day self-reported point prevalence abstinence
Nicotine replacement therapy utilization
+3 moreFreSH Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Nicotine Replacement TherapyExperimental Treatment3 Interventions
Participants will receive the Ask-Advise-Refer intervention which includes an oral health practitioner asking about their tobacco use, advising them to quit smoking, and referring them to the state quitline. They will also receive a sample bag including information about smoking and oral health, the state quitline, and a two week supply of 14mg nicotine patches and 4mg lozenges.
Group II: Electric ToothbrushActive Control1 Intervention
Participants will receive the Ask-Advise-Refer intervention which includes an oral health practitioner asking about their tobacco use, advising them to quit smoking, and referring them to the state quitline. They will also receive a sample bag including information about smoking and oral health, the state quitline, and an electric toothbrush.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ask-Advise-Refer
2016
N/A
~80
Nicotine lozenge
2019
Completed Phase 4
~1940
Find a Location
Who is running the clinical trial?
National Institute of Dental and Craniofacial Research (NIDCR)NIH
300 Previous Clinical Trials
847,412 Total Patients Enrolled
Northwestern UniversityOTHER
1,585 Previous Clinical Trials
916,031 Total Patients Enrolled
HealthPartners InstituteOTHER
184 Previous Clinical Trials
3,714,959 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a heart attack or stroke in the last 3 months.I smoke at least one cigarette daily for most of the month.I am 18 years old or older.I have used tobacco cessation medication in the last week.
Research Study Groups:
This trial has the following groups:- Group 1: Electric Toothbrush
- Group 2: Nicotine Replacement Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What risks have been identified with employing Nicotine Replacement Therapy?
"Our team at Power rated Nicotine Replacement Therapy's safety with a 2, since there is existing clinical evidence of its security but no available data on efficacy."
Answered by AI
Is enrollment into this research project open currently?
"According to information on clinicaltrials.gov, the discussed trial is not currently accepting applicants. This study was initially posted in February of 2023 and experienced a recent update in November 2022; however there are over forty other medical trials actively enrolling participants at this time."
Answered by AI
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