Cytisine Versus Varenicline for Smoking Cessation

NCT02957786 | Completed Phase 3 DMC

• 1 other identifier: UTN: U1111-1187-2838
• Study Type: interventional
• Target: 679
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effectiveness, safety, and cost-effectiveness of cytisine plus behavioural support compared to varenicline plus behavioural support for smoking cessation, in indigenous Māori (or family of Māori) who smoke and are motivated to quit.

Conditions

Smoking Cessation

Keywords

cytisine; varenicline; smoking cessation; indigenous

Outcome Measures

Primary Outcomes (1)

• Continuous abstinence from smoking

  Self-report of smoking not more than five cigarettes from the quit date, supported by biochemical validation using a carbon monoxide (CO) expired breath

  Six months post-quit date

Secondary Outcomes (35)

• Continuous abstinence from smoking

  One month post-quit date

• Continuous abstinence from smoking

  Three months post-quit date

• Continuous abstinence from smoking

  12 months post-quit date (in 2/3 of sample)

• 7-day point prevalence abstinence from smoking

  One month post-quit date

• 7-day point prevalence abstinence from smoking

  Three month post-quit date

Study Arms (2)

Cytisine plus behavioural support

EXPERIMENTAL

12-week course of cytisine capsules (1.5mg), with a decreasing dosing regimen (9mg/day for days 1-3, 7.5mg/day for days 4-12, 6mg/day for days 13-16, 4.5mg/day for days 17-20, 3.0mg/day from days 21-week 12). Participants will be asked to reduce their smoking over the first four days of treatment so that they are not smoking at all by the fifth day, which will be their designated Quit date. Participants will also withdrawal-orientated behavioural support (delivered by cessation advisors), in addition to brief cessation advice from the study-specific doctor (at the point that the prescription is provided) and community pharmacist (at the point the participant redeems their prescription).

Drug: Cytisine; Behavioral: Behavioural support

Varenicline plus behavioural support

ACTIVE COMPARATOR

12-week course of Varenicline tablets (0.5mg/1mg), with an increasing dosing regimen (0.5mg/day for days 1-3, 1.0mg/day for days 4-7, 2.0mg/day for day 8-week 12). Participants will be asked to reduce their smoking over the first four days of treatment so that they are not smoking at all by the fifth day, which will be their designated Quit date. Participants will also receive withdrawal-orientated behavioural support (delivered by cessation advisors), in addition to brief cessation advice from the study-specific doctor (at the point that the prescription is provided) and community pharmacist (at the point the participant redeems their prescription).

Behavioral: Behavioural support; Drug: Varenicline

Interventions

Cytisine DRUG

Cytisine tablets

Also known as: Tabex

Cytisine plus behavioural support

Behavioural support BEHAVIORAL

Withdrawal-orientated cessation support

Cytisine plus behavioural support; Varenicline plus behavioural support

Varenicline DRUG

Varenicline tablets

Also known as: Champix

Varenicline plus behavioural support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• daily tobacco smokers
• self-identify as Māori (indigenous New Zealander) or whānau (family) of Māori
• want to stop smoking in the next two weeks
• are at least 18 years of age
• are able to provide verbal consent
• reside in the Lakes District Health Board, Eastern Bay of Plenty or Tokoroa region at the time of enrolment
• have daily access to a mobile phone with text capability and/or email and access to the internet via computer or smartphone
• are eligible for subsidised varenicline under special authority conditions

You may not qualify if:

• are pregnant or breastfeeding
• are current users of other smoking cessation therapies (e.g. nicotine replacement therapy \[NRT\], buproprion \[Zyban\], clonidine, nortriptyline, e-cigarettes)
• are enrolled in another smoking cessation programme or another smoking cessation study
• have a contraindication for cytisine or varenicline
• have used varenicline or cytisine in the past 12 months
• have another person in their household involved in the trial
• have moderate or severe renal impairment,
• are being treated for active or latent TB
• have been treated for a heart attack, stroke, or severe angina within the last two weeks
• have uncontrolled high blood pressure (\> 150 mmHg systolic, \> 100 mmHg diastolic)
• have a history of seizures

Sponsors & Collaborators

• University of Auckland, New Zealand: lead
• Lakes District Health Board: collaborator
• Brunel University: collaborator

Study Sites (1)

National Institute for Health Innovation, University of Auckland

Auckland, North Island, 1072, New Zealand

Location

Related Publications (2)

• Walker N, Smith B, Barnes J, Verbiest M, Kurdziel T, Parag V, Pokhrel S, Bullen C. Cytisine versus varenicline for smoking cessation for Maori (the indigenous people of New Zealand) and their extended family: protocol for a randomized non-inferiority trial. Addiction. 2019 Feb;114(2):344-352. doi: 10.1111/add.14449. Epub 2018 Nov 9.

  PMID: 30276931 BACKGROUND

• Walker N, Smith B, Barnes J, Verbiest M, Parag V, Pokhrel S, Wharakura MK, Lees T, Cubillos Gutierrez H, Jones B, Bullen C. Cytisine versus varenicline for smoking cessation in New Zealand indigenous Maori: a randomized controlled trial. Addiction. 2021 Oct;116(10):2847-2858. doi: 10.1111/add.15489. Epub 2021 May 4.

  PMID: 33761149 RESULT

MeSH Terms

Conditions

Smoking Cessation

Interventions

cytisine; Varenicline

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Study Officials

• Natalie Walker, PhD

  University of Auckland, New Zealand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 27, 2016
• First Posted: November 8, 2016
• Study Start: September 18, 2017
• Primary Completion: October 10, 2019
• Study Completion: October 10, 2019
• Last Updated: August 19, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share

Locations

NZ (1)