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Varenicline For Smokers In Recovery From Alcohol Dependence

Primary Purpose

Tobacco Abstinence

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Varenicline

About this trial

This is an interventional treatment trial for Tobacco Abstinence focused on measuring Tobacco Dependence, Smoking, Tobacco Cessation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Male or non-pregnant female cigarette smoker; 18-years-of-age or older and reporting smoking at least an average of 10 cigarettes per day for the past year.
A history of alcohol dependence based on DSM IV criteria as assessed by the Alcohol Dependence Scale and the physician investigator
A minimum of 6 months of abstinence from alcohol use as assessed by the physician investigator
Subject must be able to complete all the study visits
Subject must be in general good health as determined by medical history, physical exam and physician investigator
Subject must provide written informed consent to participate in the study.

Exclusion Criteria:

Current treatment with another investigational drug.
Current use (within past 30 days) of nicotine replacement therapy, bupropion, rimonabant, varenicline, nortriptyline, clonidine, or other medications known to be effective for treating tobacco dependence.
Subject has current (past 30 days) major depressive disorder or has a history of another psychiatric disorder such as psychosis or bipolar disorder.
Current (past 6 months) drug abuse corroborated by the Drug Abuse Screening Test (DAST-20) and physician interview.
Regular use of other tobacco products (i.e. pipe, cigar, smokeless tobacco) within the past 30 days.
Females who are pregnant, lactating or likely to become pregnant during the trial and not willing to use an acceptable form of contraception during the medication phase. For women of child-bearing potential, a pregnancy test will be performed prior to entry into the study and at the end of the medication phase.
A history of a major cardio-vascular event in the past 3 months including unstable angina, acute MI or coronary angioplasty.
Known allergy to varenicline.

Sites / Locations

Mayo Clinic Nicotine Research Program

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Varenicline

Arm Description

Everyone on study will receive Varenicline daily for 12 weeks

Outcomes

Primary Outcome Measures

Biochemically Confirmed Abstinence From Smoking

The primary endpoint of this trial is biochemically confirmed 7-day point prevalence smoking abstinence at the end of the medication phase (week 12). Self-reported abstinence from smoking (not even a puff) over the last 7-days will be considered biochemically confirmed by an expired air CO of <8 ppm. Subjects who discontinue the study or have a missed visit for any reason will be classified as smoking for that visit.

Secondary Outcome Measures

Full Information

NCT ID

NCT01092702

First Posted

March 19, 2010

Last Updated

September 5, 2023

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT01092702

Brief Title

Varenicline For Smokers In Recovery From Alcohol Dependence

Official Title

A Pilot Study of Varenicline for Tobacco Dependence Treatment in Recovering Alcoholic Smokers: the Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

April 2008 (undefined)

Primary Completion Date

September 2008 (Actual)

Study Completion Date

September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Mayo Clinic

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The goal of this proposal is to explore the potential effectiveness of varenicline to treat tobacco dependence among recovering alcoholic smokers who, as a group, are at high risk for tobacco-caused morbidity and mortality. In this open-label phase II clinical trial, we are proposing to enroll 32 recovering alcoholic smokers who are motivated to stop smoking. After the initial up titration of varenicline in week 1, all 32 subjects will receive a total of 2 mg/day of varenicline for 12 weeks. In addition to receiving varenicline, all subjects will receive brief behavioral counseling and our standard intervention at each visit during participation in the study.

Detailed Description

This is an open-label, phase II clinical trial. All subjects will be screened for study eligibility after providing informed consent. During the clinic screen visit the subjects are informed of the study, the study informed consent is signed by the subject and staff member, a series of screening tests are conducted and screening criteria are reviewed. Once enrolled in study, the subject will return for a face to face clinic visit weekly for the first 4 weeks (visits 3-6) and then biweekly for the last 8 weeks(visits 7-10). Target quit day is the day after visit 3 (week 1 visit). During the first week varenicline will be started at a dose of 0.5 mg once daily for days 1-3; then 0.5 mg twice daily for days 4-7. Target quit date is set at day 8. Varenicline is then continued for weeks 2-12 at a dose of 1 mg twice daily. Subjects will return weekly for 4 weeks then bi-weekly for the remaining 8 weeks. The study end-date will be Week 12, which is also the end-of-treatment date.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tobacco Abstinence

Keywords

Tobacco Dependence, Smoking, Tobacco Cessation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Varenicline

Arm Type

Other

Arm Description

Everyone on study will receive Varenicline daily for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Varenicline

Other Intervention Name(s)

Varenicline Tartrate, Chantix (in the USA), Champix (in Europe)

Intervention Description

During the first week varenicline will be started at a dose of 0.5 mg once daily for days 1-3; then 0.5 mg twice daily for days 4-7. Target quit date is set at day 8. Varenicline is then continued for weeks 2-12 at a dose of 1 mg twice daily.

Primary Outcome Measure Information:

Title

Biochemically Confirmed Abstinence From Smoking

Description

Time Frame

12 weeks from start of medication

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or non-pregnant female cigarette smoker; 18-years-of-age or older and reporting smoking at least an average of 10 cigarettes per day for the past year. A history of alcohol dependence based on DSM IV criteria as assessed by the Alcohol Dependence Scale and the physician investigator A minimum of 6 months of abstinence from alcohol use as assessed by the physician investigator Subject must be able to complete all the study visits Subject must be in general good health as determined by medical history, physical exam and physician investigator Subject must provide written informed consent to participate in the study. Exclusion Criteria: Current treatment with another investigational drug. Current use (within past 30 days) of nicotine replacement therapy, bupropion, rimonabant, varenicline, nortriptyline, clonidine, or other medications known to be effective for treating tobacco dependence. Subject has current (past 30 days) major depressive disorder or has a history of another psychiatric disorder such as psychosis or bipolar disorder. Current (past 6 months) drug abuse corroborated by the Drug Abuse Screening Test (DAST-20) and physician interview. Regular use of other tobacco products (i.e. pipe, cigar, smokeless tobacco) within the past 30 days. Females who are pregnant, lactating or likely to become pregnant during the trial and not willing to use an acceptable form of contraception during the medication phase. For women of child-bearing potential, a pregnancy test will be performed prior to entry into the study and at the end of the medication phase. A history of a major cardio-vascular event in the past 3 months including unstable angina, acute MI or coronary angioplasty. Known allergy to varenicline.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James T Hays, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic Nicotine Research Program

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

20947286

Citation

Hays JT, Croghan IT, Schroeder DR, Ebbert JO, Hurt RD. Varenicline for tobacco dependence treatment in recovering alcohol-dependent smokers: an open-label pilot study. J Subst Abuse Treat. 2011 Jan;40(1):102-7. doi: 10.1016/j.jsat.2010.08.009. Epub 2010 Oct 13.

Results Reference

result

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Varenicline For Smokers In Recovery From Alcohol Dependence

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