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Personalized Dosing of Nicotine Replacement (NRT to Effect)

NCT03000387 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 211

Last updated 2024-01-29

No results posted yet for this study

Summary

Medications for smoking cessation are currently only effective in helping a minority of smokers quit. Drug development is slow and expensive, so there is much interest in optimizing the effectiveness of existing treatments and medications. Current standard doses of nicotine replacement therapy (NRT) are not effective for many smokers and in many cases provide less nicotine compared to when a smoker is smoking their usual number of cigarettes. The proposed study will test if a personalized dose of nicotine patch (up to 84mg) will improve quitting success in those who do not respond to a standard dose of NRT (21mg).

Conditions

  • Tobacco Use Disorder
  • Nicotine Dependence

Interventions

DRUG

Nicotine Patch

Active nicotine patch of 21 mg, 14 mg and 7 mg

DRUG

Placebos

Matching placebo patches of 21 mg, 14 mg and 7 mg

Sponsors & Collaborators

  • Canadian Cancer Society (CCS)

    collaborator OTHER

  • Ottawa Heart Institute Research Corporation

    collaborator OTHER

  • Centre for Addiction and Mental Health

    lead OTHER

Principal Investigators

  • Laurie Zawertailo, PhD · Centre for Addiction and Mental Health

  • Peter Selby, MBBS · Centre for Addiction and Mental Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-23
Primary Completion
2023-02-27
Completion
2023-12-11

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03000387 on ClinicalTrials.gov