Extended (6-Week) Varenicline Preloading: Does it Facilitate Smoking Reduction and Cessation?

NCT02634281 | Completed Phase 4

• 1 other identifier: 0239-15-SZMC
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

Brief Summary

SUMMARY Rationale: Worldwide, cigarette smoking carries a high mortality. Since the available cessation programs are not effective for all smokers, new strategies are necessary for tobacco control. Primary objective: To investigate whether a 6-week varenicline preloading facilitates smoking reduction and cessation compared with the standard varenicline treatment schedule. Design: Parallel group, double-blind, randomised controlled clinical trial. Participants: Smokers of both sexes from the general population. Methods: Participants will be randomized into two groups of treatment. Subjects in Group A will receive varenicline for six weeks while those in group B will receive placebo for 5 weeks and varenicline for 1 week. During this phase, subjects in both groups will be asked to reduce cigarette smoking by 50 percent. At week 6 all participants will be instructed to stop smoking before receiving 12 weeks of varenicline treatment. Visits will be arranged at randomization, week 4, week 6 (Quit day (QD)) and at week 1, 6, 12, and 24 after QD. Measurements: These will include vital signs, smoking history, spirometry, expired CO, salivary cotinine, nicotine dependence, and withdrawal symptoms. Primary outcome is continuous abstinence at 6 months. Sample size: For an estimated difference of quit rates of 15% at 24 weeks (30% for group A vs. 15% for group B) 121 subjects per group are needed (Total = 242 subjects). Statistical analysis: T tests (rational variables) and x2 test or Fisher's exact test (nominal variables) will be used as appropriate. Expected benefits: This study might contribute to optimize the current use of varenicline.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• Continuous abstinence

  defined as avoidance of tobacco (not a single puff) since the quit date. It will be assessed by self-reported complete abstinence and expired CO \< 10 ppm from week 7 until endpoint. The occurrence of occasional lapses after week 7 will be categorised as a failure in the main evaluation, but will not necessitate withdrawal if the subject is willing to continue and is considered by the investigators as competent to succeed.

  from week 7 until week 24

Secondary Outcomes (5)

• smoking reduction

  from week 7 until week 24

• Decline in pulmonary function

  from week 7 until week 24

• adverse events

  from week 7 until week 24

• Symptoms and physical signs associated with withdrawal: MPSS questionnaire

  from week 7 until week 24

• Use of cigarettes

  from week 7 until week 24

Study Arms (2)

group A

EXPERIMENTAL

Subjects in Group A will receive varenicline for six weeks .During this phase, subjects will be asked to reduce cigarette smoking by 50 percent. At week 6 all participants will be instructed to stop smoking before receiving 12 weeks of varenicline treatment

Drug: Varenicline

group B

ACTIVE COMPARATOR

group B will receive placebo for 5 weeks and varenicline for 1 week. During this phase, subjects will be asked to reduce cigarette smoking by 50 percent. At week 6 all participants will be instructed to stop smoking before receiving 12 weeks of varenicline treatment

Drug: Varenicline; Drug: placebo

Interventions

Varenicline DRUG

Subjects in Group A will receive varenicline for six weeks while those in group B will receive placebo for 5 weeks and varenicline for 1 week. During this phase, subjects in both groups will be asked to reduce cigarette smoking by 50 percent. At week 6 all participants will be instructed to stop smoking before receiving 12 weeks of varenicline treatment

Also known as: champix, chantix

group A; group B

placebo DRUG

Subjects in Group A will receive varenicline for six weeks while those in group B will receive placebo for 5 weeks and varenicline for 1 week. During this phase, subjects in both groups will be asked to reduce cigarette smoking by 50 percent. At week 6 all participants will be instructed to stop smoking before receiving 12 weeks of varenicline treatment

group B

Eligibility Criteria

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

You may qualify if:

• Men or women aged ≥18 years
• Currently smoking 10 cigarettes per day or more
• Having smoked 5 py or more
• Presenting a CO level in expired air ≥ 10 ppm
• Personally motivated to reduce or stop smoking and indicating a willingness to follow through with protocol requirements
• Willing to sign a statement of informed consent

You may not qualify if:

• Myocardial infarction within the last 3 months
• Unstable angina
• Severe cardiac arrhythmia
• Pregnancy or breast feeding
• Use of any form of smokeless tobacco or nicotine substitution
• Having followed any smoking cessation programme during the last 3 months
• Alcohol or other drug addiction
• Use of any form of smokeless tobacco or nicotine substitution
• Participation in any clinical trial within the past 3 months
• Women in childbearing age not willing to use contraception until week 12 after QD

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (1)

Shaare Zedek Medical center

Jerusalem, 9103102, Israel

Location

Related Publications (1)

• Bohadana A, Freier-Dror Y, Peles V, Babai P, Izbicki G. Extending varenicline preloading to 6 weeks facilitates smoking cessation: A single-site, randomised controlled trial. EClinicalMedicine. 2020 Feb 3;19:100228. doi: 10.1016/j.eclinm.2019.11.021. eCollection 2020 Feb.

  PMID: 32055787 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• Abraham BOHADANA, MD

  Shaare zedek medical center, pulmonary institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: December 18, 2015
• Study Start: February 1, 2016
• Primary Completion: June 28, 2018
• Study Completion: June 28, 2018
• Last Updated: October 5, 2021

Record last verified: 2019-04

Locations

IL (1)