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Nicotine Replacement Therapy

Personalized Dosing of Nicotine Patches for Nicotine Addiction

Phase 4
Waitlist Available
Led By Laurie Zawertailo, PhD
Research Sponsored by Centre for Addiction and Mental Health
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 weeks 9-52
Awards & highlights

Study Summary

This trial will test if a higher dose of nicotine in patch form helps smokers quit when the standard dose fails.

Eligible Conditions
  • Tobacco Use Disorder
  • Nicotine Addiction

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 9-52
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 9-52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Short term continuous abstinence
Secondary outcome measures
Long term continuous abstinence

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Experimental ConditionExperimental Treatment1 Intervention
Participants unable to quit smoking after 2 weeks of treatment with 21mg nicotine patch will get 21mg nicotine patches plus additional active nicotine patches until achieving 7 consecutive days of abstinence over the next 5 weeks; maximum daily patch dose, 84mg/day
Group II: Quit conditionActive Control1 Intervention
Participants able to quit for 7 consecutive days during the first 2 weeks of treatment with 21mg nicotine patch will continue open label 21mg active nicotine patches for the remaining 10 weeks.
Group III: Placebo ConditionPlacebo Group2 Interventions
Participant unable to quit smoking after 2 weeks of treatment with 21mg nicotine patch will get 21mg nicotine patches plus placebo patches until 7 consecutive days of abstinence over the next 5 weeks; Maximum daily patch dose, 21mg active nicotine patch plus 3 placebo 21mg patches.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotine
FDA approved

Find a Location

Who is running the clinical trial?

Centre for Addiction and Mental HealthLead Sponsor
354 Previous Clinical Trials
80,909 Total Patients Enrolled
25 Trials studying Tobacco Use Disorder
4,143 Patients Enrolled for Tobacco Use Disorder
Ottawa Heart Institute Research CorporationOTHER
188 Previous Clinical Trials
92,225 Total Patients Enrolled
1 Trials studying Tobacco Use Disorder
1,208 Patients Enrolled for Tobacco Use Disorder
Canadian Cancer Society (CCS)OTHER
78 Previous Clinical Trials
37,534 Total Patients Enrolled
1 Trials studying Tobacco Use Disorder
1,200 Patients Enrolled for Tobacco Use Disorder

Media Library

Nicotine Patch (Nicotine Replacement Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03000387 — Phase 4
Tobacco Use Disorder Research Study Groups: Placebo Condition, Experimental Condition, Quit condition
Tobacco Use Disorder Clinical Trial 2023: Nicotine Patch Highlights & Side Effects. Trial Name: NCT03000387 — Phase 4
Nicotine Patch (Nicotine Replacement Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03000387 — Phase 4

Frequently Asked Questions

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

How many participants are being admitted to this clinical trial?

"Correct. Clinicaltrials.gov confirms that this study is actively recruiting, with 500 participants needing to be enrolled from 1 medical centre. This trial was first posted on January 23rd 2018 and the most recent update occurred on August 23rd 2022."

Answered by AI

Are there any openings for participation within this clinical experiment?

"Affirmative. Clinicaltrials.gov data suggests that recruitment for this trial is still ongoing, having first been posted on January 23rd 2018 and last updated on August 23rd 2022. The research team are seeking out 500 participants from 1 study site."

Answered by AI

Has the FDA endorsed nicotine patch as a viable means of cessation?

"Due to the fact that this is a Phase 4 trial with an approved treatment, we at Power rate nicotine patch's safety as 3 on our scale."

Answered by AI

Is it feasible for me to sign up for this clinical trial?

"This clinical trial is recruiting 500 people with tobacco addiction between the ages of 18 and 75. To be eligible, applicants must have a daily habit of 10 cigarettes or more, express an interest in tNRT as their primary smoking cessation aid, meet the age criteria listed above, and plan to quit within 30 days."

Answered by AI

Has there been any previous research regarding the utilization of Nicotine Patch?

"As of the present moment, 71 clinical trials concerning Nicotine Patches are underway and 5 have progressed to Phase 3. Most studies are located in Green Bay, Wisconsin but 204 medical centres across the US offer this trial."

Answered by AI

Is this trial accessible to adults aged eighteen and above?

"This medical trial is accepting applicants aged between 18 years and 75 years."

Answered by AI
~29 spots leftby Apr 2025