Tobacco AbstinencePhase 2/3NCT01092702
Varenicline For Smokers In Recovery From Alcohol Dependence
A Phase 2/3 study testing Varenicline in people with Tobacco Abstinence, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Abstinence
- What is being tested?
- Varenicline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Sep 2009
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic Nicotine Research Program
Rochester, Minnesota, 55905
About this study
Official title: A Pilot Study of Varenicline for Tobacco Dependence Treatment in Recovering Alcoholic Smokers: the Clinical Trial
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.
Read the 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.
- Conditions
- Tobacco Abstinence
- Being tested
- Varenicline
- Keywords
- Tobacco Dependence, Smoking, Tobacco Cessation
- Medical subject headings
- Tobacco Use Disorder, Smoking, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Also called Varenicline Tartrate, Chantix (in the USA), Champix (in Europe)
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.
| Study group | Role | What they receive |
|---|---|---|
| Varenicline | Other | Everyone on study will receive Varenicline daily for 12 weeks Receives: Drug: Varenicline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks from start of medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2010 (estimated)
- Study startApr 2008
- Primary completionSep 2008
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco AbstinenceStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- James T Hays, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01092702
- Sponsor's protocol ID
- 08-00672
- Status last verified
- Sep 2023
- First submitted
- 19 Mar 2010
- Last updated
- 25 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 20947286
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Varenicline for Tobacco Dependence Treatment in Recovering Alcoholic Smokers: the Clinical Trial
- ClinicalTrials.gov ID
- NCT01092702
- Acronym / sponsor ID
- 08-00672
- Conditions
- Tobacco Abstinence
- Keywords
- Tobacco Dependence, Smoking, Tobacco Cessation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 25 Mar 2010 (estimated)
- Results
- Posted 30 Nov 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Varenicline | Other | Drug: VareniclineEveryone on study will receive Varenicline daily for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VareniclineAlso: Varenicline Tartrate, Chantix (in the USA), Champix (in Europe)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. | Drug | Varenicline |
Primary outcome
Biochemically Confirmed Abstinence From Smoking
Time frame: 12 weeks from start of medication
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20947286Hays 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James T Hays, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Varenicline in people with Tobacco Abstinence, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Nov 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemically Confirmed Abstinence From Smoking (time frame: 12 weeks from start of medication). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01092702, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023.