Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02894957
Recruitment Status : Not yet recruiting
First Posted : September 9, 2016
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Shaare Zedek Medical Center

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.


Condition or disease Intervention/treatment Phase
Smoking Cessation Drug: Varenicline Phase 4

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Varenicline for "Gradual" vs. "Abrupt" Smoking Cessation in Low-motivated COPD Smokers: A Randomized Pilot Study
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Gradual smoking cessation

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
: 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.
Other Name: champix

Active Comparator: Abrupt smoking cessation
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
: 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.
Other Name: champix




Primary Outcome Measures :
  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. [ Time Frame: week 10 to week 30 ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: week 10 to week 18 ]
  2. 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. [ Time Frame: 3 month and 6 month ]
  3. 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. [ Time Frame: from baseline to week 6 ]
  4. Number of subjects quitting smoking before week 6: The number of subjects quitting smoking at week 4 will be computed for the two groups. [ Time Frame: week 4 ]
  5. Differential dropout rate: In order to assess motivational bias this will be calculated at baseline [ Time Frame: at baseline ]
  6. Cigarettes/day: The number of cigarettes smoked per day will be assessed for all participants at all visits. [ Time Frame: week 30 ]
  7. Reported smoking reduction: CO level . [ Time Frame: from baseline until week 30 ]
    smoking reduction will be defined by decrease in expired CO levels

  8. Decline in pulmonary function: The rate of decline of spirometric parameters will be calculated as the difference between the baseline value and the value observed at end-study. [ Time Frame: baseline and week 30 ]
  9. Adverse events: All subjects will be asked about adverse events at each visit by an open-ended question. [ Time Frame: week 30 ]
  10. Reported smoking reduction: number of cigarettes. [ Time Frame: from baseline until week 30 ]
    smoking reduction will be defined by the reported decrease of number of cigarettes .



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02894957


Contacts
Layout table for location contacts
Contact: Abraham Bohadana, MD 97226545141 abohadana@szmc.org.il
Contact: Gabriel IZBICKI, MD 97226666278 izbicki@szmc.org.il

Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Abraham BOHADANA, MD Shaare Zedek Medical Center

Layout table for additonal information
Responsible Party: Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT02894957     History of Changes
Other Study ID Numbers: 0231-15-SZMC
First Posted: September 9, 2016    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs