Varenicline For Smokers In Recovery From Alcohol Dependence

NCT01092702 | Completed Phase 2 Results

• 1 other identifier: 08-00672
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Abstinence

Keywords

Tobacco Dependence; Smoking; Tobacco Cessation

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks from start of medication

Study Arms (1)

Varenicline

OTHER

Everyone on study will receive Varenicline daily for 12 weeks

Drug: Varenicline

Interventions

Varenicline DRUG

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.

Also known as: Varenicline Tartrate, Chantix (in the USA), Champix (in Europe)

Varenicline

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Nicotine Research Program

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  PMID: 20947286 RESULT

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking; Tobacco Use Cessation

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: J Taylor Hays. MD
• Organization: Mayo Clinic

nicotineresearch@mayo.edu

507-266-1944

Study Officials

• James T Hays, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 19, 2010
• First Posted: March 25, 2010
• Study Start: April 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2009
• Last Updated: September 25, 2023
• Results First Posted: November 30, 2010

Record last verified: 2023-09

Locations

US (1)