Varenicline for "Gradual" vs. "Abrupt" Smoking Cessation in Low-motivated COPD Smokers

NCT02894957 | Unknown Phase 4 DMC

• 1 other identifier: 0231-15-SZMC
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

Rationale: No studies have examined the effect of varenicline for "gradual" smoking cessation in COPD smokers currently not interested in quitting. Objective: To compare the efficiency of varenicline-assisted "gradual" vs. "abrupt" smoking cessation in low-motivated COPD smokers Setting: Pulmonary outpatient clinic Design: Open, randomized pilot smoking cessation trial Participants: COPD smokers with low motivation to quit. Such low motivation will be defined as a score of ≤ 3 points observed in a 10 cm visual analog scale (0=non motivated; 10=highly motivated). Interventions/procedures: Patients will be randomized either to receive varenicline (uptitrated to 1 mg twice daily) for smoking reduction or smoke as usual for 4-6 weeks before quitting. After quit-day, the two groups will receive standard 12-week varenicline treatment. Non-treatment follow-up will continue to 6 months. Measurements: The main outcome measure is carbon monoxide-verified complete abstinence rate (CAR) 6 months after quit-day. Other measures are: CAR at 3 months; point prevalence at 3 and 6 months; change in motivation; cigarettes/day; differential dropout rate; decline in pulmonary function; COPD symptoms, episodes of exacerbation and medication; and adverse events. Sample size: One hundred twenty-one subjects per group will be necessary to detect CAR differences between the two groups of 15% at 6 months. Potential study limitations: The main potential limitation is the lack of 1-yr follow-up. Relevance: This study may provide useful preliminary information on the safety and efficiency of varenicline for "gradual" smoking cessation in low-motivated COPD smokers and it may assist in the preparation of a larger, more comprehensive trial.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• Continuous abstinence from week 10 to week 30: This will be defined as self-reported non-smoking combined with an expired CO level ≤ 5 ppm from week 10 through week 30.

  week 10 to week 30

Secondary Outcomes (10)

• Continuous abstinence from week 10 to week 18: This will be defined as self-reported non-smoking combined with an expired CO level ≤ 5 ppm from week 10 through week 18.

  week 10 to week 18

• Point-prevalence after 3 months and 6 months: This will be defined as abstinence at these time points verified by an exhaled CO level ≤ 5 ppm.

  3 month and 6 month

• Motivation to quit: This will be assessed from baseline through quit day. An improvement in motivation in the pre-quitting phase will be defined as an increase in the VAS value from ≤ 3 points at baseline to ≥ 5 points thereafter.

  from baseline to week 6

• Number of subjects quitting smoking before week 6: The number of subjects quitting smoking at week 4 will be computed for the two groups.

  week 4

• Differential dropout rate: In order to assess motivational bias this will be calculated at baseline

  at baseline

Study Arms (2)

Gradual smoking cessation

EXPERIMENTAL

Gradual cessation Patients randomized to the "gradual" cessation group will receive varenicline (0,5 mg once daily for 3 days, 0,5 mg twice daily for 4 days, and 1,0 mg bid thereafter) as an aid for smoking reduction. This pre-treatment phase will last 6 weeks at the end of which all participants must stop smoking altogether. After quitting, they will continue to receive varenicline 1,0 mg bid for a further 12 weeks. Smoking reduction: Participants will be recommended to reduce their smoking by 25% in the first two weeks, 50% in weeks 3-4, and 75% in weeks 5-6; however, this will be given only as an indication and every subject will be allowed to chose his/her own goal and rate of progress.

Drug: Varenicline

Abrupt smoking cessation

ACTIVE COMPARATOR

Patients in this group will be asked to smoke as usual for 6 weeks after enrolment then stop altogether. However, those feeling ready will be allowed to quit as of week 4. Thereafter, they will receive the standard 12-week varenicline treatment, starting with a 1 week titration period as described above.

Drug: Varenicline

Interventions

Varenicline DRUG

: Patients will be randomized either to receive varenicline (uptitrated to 1 mg twice daily) for smoking reduction or smoke as usual for 4-6 weeks before quitting. After quit-day, the two groups will receive standard 12-week varenicline treatment. Non-treatment follow-up will continue to 6 months.

Also known as: champix

Abrupt smoking cessation; Gradual smoking cessation

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women aged ≥35 years
• Currently smoking 10 cigarettes per day or more
• Having smoked 15 py or more
• Presenting a CO level in expired air ≥ 10 ppm
• With low motivation to quit as defined below.
• Willing to sign a statement of informed consent
• Willing to sign a written commitment to quit at a target quit date
• Women of child bearing potential should agree to use acceptable contraception methods.

You may not qualify if:

• History of treatment with systemic corticosteroids or hospitalization for a COPD exacerbation in the 4-wk period prior to enrolment.
• Diagnosis of depression or current treatment with antidepressants.
• History of serious psychiatric disorder.
• Myocardial infarction within the last 3 months
• Unstable angina
• Severe cardiac arrhythmia
• Use of any form of smokeless tobacco or nicotine substitution or having followed any cessation program in the past 3 months
• Alcohol or other drug addiction
• Pregnant or lactating women

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Related Publications (1)

• Bohadana A, Rokach A, Wild P, Peker B, Dror YF, Babai P, Arish N, Izbicki G. Varenicline for Gradual Versus Abrupt Smoking Cessation in Poorly Motivated Smokers With COPD: A Prematurely Terminated Randomized Controlled Trial. Chronic Obstr Pulm Dis. 2022 Oct 26;9(4):486-499. doi: 10.15326/jcopdf.2022.0305.

  PMID: 35877930 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abraham Bohadana, MD

CONTACT

97226545141; abohadana@szmc.org.il

Gabriel IZBICKI, MD

CONTACT

97226666278; izbicki@szmc.org.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2016
• First Posted: September 9, 2016
• Study Start: October 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: September 24, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share