Personalized Dosing of Nicotine Replacement (NRT to Effect)

NCT03000387 | Completed Phase 4

• 1 other identifier: 039/2015
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Nicotine Replacement Therapy; Smoking Cessation; Randomized Clinical Trial; Nicotine Patch; Abstinence; Placebo; Double blind

Outcome Measures

Primary Outcomes (1)

• Short term continuous abstinence

  YES, If self-reported 4 weeks of abstinence without a single puff of a cigarette or any other tobacco product. Else, NO.

  weeks 9 to 12

Secondary Outcomes (2)

• Long term continuous abstinence

  weeks 9-26

• Long term continuous abstinence

  weeks 9-52

Study Arms (3)

Experimental Condition

EXPERIMENTAL

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

Drug: Nicotine Patch

Placebo Condition

PLACEBO COMPARATOR

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.

Drug: Nicotine Patch; Drug: Placebos

Quit condition

ACTIVE COMPARATOR

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.

Drug: Nicotine Patch

Interventions

Nicotine Patch DRUG

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

Also known as: Nicoderm

Experimental Condition; Placebo Condition; Quit condition

Placebos DRUG

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

Also known as: Placebo patch

Placebo Condition

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Daily tobacco smoker of ≥10 cigarettes per day
• Aged 18 to 75 years old
• Interested in using tNRT as the only smoking cessation aid
• Intending to quit smoking within the next 30 days

You may not qualify if:

• At least weekly use of tobacco products other than cigarettes and not willing to stop for the duration of the study
• Breast feeding, pregnancy or not using a reliable form of birth control
• Any generalized skin disorders precluding the use of the patch
• Any life threatening arrhythmias or severe/worsening angina pectoris or within two weeks of experiencing a myocardial infarction or cerebral vascular accident
• Currently using or has used NRT or other smoking cessation pharmacotherapy within the past two weeks
• Any known hypersensitivity or allergies to any of the components comprising the nicotine patch
• Current active substance dependence (excluding caffeine) which would compromise study compliance
• Current unstable psychiatric condition which would compromise study compliance
• Diagnosis of terminal illness
• Current regular use of e-cigarettes or other vaping devices containing nicotine and not willing to stop for the duration of the study

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• Canadian Cancer Society (CCS): collaborator
• Ottawa Heart Institute Research Corporation: collaborator

Study Sites (2)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

Location

Related Publications (2)

• Theodoulou A, Chepkin SC, Ye W, Fanshawe TR, Bullen C, Hartmann-Boyce J, Livingstone-Banks J, Hajizadeh A, Lindson N. Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2023 Jun 19;6(6):CD013308. doi: 10.1002/14651858.CD013308.pub2.

  PMID: 37335995 DERIVED

• Zawertailo L, Hendershot CS, Tyndale RF, Le Foll B, Samokhvalov AV, Thorpe KE, Pipe A, Reid RD, Selby P. Personalized dosing of nicotine replacement therapy versus standard dosing for the treatment of individuals with tobacco dependence: study protocol for a randomized placebo-controlled trial. Trials. 2020 Jun 29;21(1):592. doi: 10.1186/s13063-020-04532-7.

  PMID: 32600406 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking Cessation

Interventions

Tobacco Use Cessation Devices; Nicotine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Laurie Zawertailo, PhD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

• Peter Selby, MBBS

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: December 22, 2016
• Study Start: January 23, 2018
• Primary Completion: February 27, 2023
• Study Completion: December 11, 2023
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)