SmokingPhase 2/3NCT01347112

Varenicline Treatment for Active Alcoholic Smokers

A Phase 2/3 study testing Varenicline in people with Smoking and Tobacco Dependence, run by Mayo Clinic at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Smoking, Tobacco Dependence, Alcohol Dependence
What is being tested?: Varenicline
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 33 participants
Where: 2 sitesUnited States
Study dates: Jun 2011to Mar 2014
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 smokers 18-years-of-age or older and reporting smoking at least an average of 10 cigarettes per day for the past year;
Subject is alcohol dependence based on DSM IV criteria as assessed by the Mini-International Neuropsychiatric Interview (MINI) and the physician investigator;3
Subject is currently drinking alcoholic beverages as assessed by the physician investigator;
Subject is a female subject of non-childbearing potential or a female subject of childbearing potential - who is using contraceptives and has a negative pregnancy test result;
Subject must be able to complete all the study visits;
Subject has the ability to participate fully in all aspects of the study and keep scheduled appointments;
Subject must be in good general 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

Subject is a female who is 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);
Subject has another household member in study;
Known allergy to varenicline;
Subject is currently (in previous 30 days) using other behavioral or pharmacologic tobacco cessation program (i.e., behavioral therapy, nicotine replacement therapy, clonidine, varenicline, bupropion SR, nortriptyline or doxepin) and unwilling or unable to discontinue use;
Subject has an unstable medical condition as determined by the physician investigator;
Subject describes having a medical history of: a) unstable angina; b) myocardial infarction within the past 3 months; c) coronary angioplasty or d) an untreated cardiac dysrhythmia;

Show all 15Show fewer

Subject has a personal history of renal failure or is on renal dialysis;
Subject has a current moderate or severe depression as assessed by the Center for Epidemiologic Studies-Depression survey (CES-D) and physician investigator;
Subject has, as defined by the Columbia Suicide Severity Rating Scale (C-SSRS) current non-specific suicidal thoughts, or have a lifetime history of a suicidal attempt (defined as "potentially self-injurious act committed with at least some wish to die, as a result of act");
Subject has current (past 30 days) major depressive disorder or has a history of another psychiatric disorder such as psychosis or bipolar disorder;
Subject currently uses of other tobacco products (i.e. pipe, cigar, smokeless tobacco) within the past 30 days;
Subject currently has cancer [excluding non melanoma skin cancer] not in remission (cancer free for 5 years or more);
Subject currently has Type 1 diabetes;
Subject has untreated hypertension or baseline systolic blood pressure > 180 or diastolic > 100;
Subject is currently on treatment with another investigational drug (within 30 days of study entry);

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Franciscan Skemp Hospital
La Crosse, Wisconsin, 54601
Mayo Clinic in Rochester
Rochester, Minnesota, 55905

Other trials in United States

About this study

Alcohol dependence is a significant and prevalent public health problem affecting approximately 4% of the U.S. adult population. Individuals with alcohol dependence actively seek treatment annually, and long-term alcohol abstinence varies from 40-60%. Because of the high smoking prevalence and trends toward heavier smoking, alcoholic smokers are at high risk for both morbidity and mortality related to alcohol consumption and tobacco dependence. Although several studies have evaluated pharmacotherapy for tobacco dependence in recovering alcoholic smokers, few have evaluated pharmacotherapy for tobacco dependence among currently drinking alcoholic smokers.

Varenicline is the most effective medication currently available for treating tobacco dependence. While some randomized trials have included recovering alcoholics, active alcoholism has been an exclusion criteria for these trials. Thus, this proposal would be the first such clinical trial in currently drinking alcoholic smokers. In addition to helping smokers to stop smoking, varenicline has also been shown to reduce alcohol consumption in rats. The goal of this proposal is to explore the potential efficacy of varenicline for treating tobacco dependence and reducing drinking among alcohol dependent smokers.

The investigators hypothesize that 12 weeks of treatment with varenicline, a partial nicotinic acetylcholine receptor agonist will be more effective than placebo in treating tobacco dependence and reducing nicotine withdrawal symptoms in currently drinking alcoholic smokers. The investigators will also explore whether varenicline has an effect on drinking behavior among currently drinking alcoholics. The investigators propose the following specific aims to test these hypotheses in 70 currently drinking alcoholic smokers recruited at the Mayo Clinic in Rochester, Minnesota.

Read the detailed description

Seventy smokers who are currently alcohol dependent will be enrolled to this study. If found to be study eligible they will be randomized to either active varenicline or placebo for 12 weeks. During these two weeks, they will be seen either weekly or biweekly. At the end of treatment, they will be followed up for an addition 12 weeks. Their last study visit will be 6 months after randomization.

Conditions: Smoking, Tobacco Dependence, Alcohol Dependence
Being tested: Varenicline, placebo
Keywords: smoking, tobacco dependence, alcohol dependence
Medical subject headings: Smoking, Tobacco Use Disorder, Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VareniclineDrug
Also called chantix, champix, varenicline tartrate
varenicline 1.0 mg dose, twice daily for 12 weeks
placeboDrug
Also called sugar pill
sugar pill twice daily for 12 weeks

Study groups in NCT01347112
Study group	Role	What they receive
Varenicline	Active comparator	varenicline 1.0 mg twice daily for 12 weeks Receives: Drug: Varenicline
Sugar Pil	Placebo comparator	Varenicline look alike sugar pill twice daily for 12 weeks Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Prolonged Smoking Abstinence at End of 12 Weeks of Varenicline Treatment
Prolonged smoking abstinence will be identified by a negative response to the question, "Since 2 weeks after your TQD, have you smoked any tobacco, even a puff, for 7 consecutive days or at least once each week on 2 consecutive weeks?"
Measured: 12 weeks

Secondary outcomes (2)

Prolonged Abstinence at 24 Weeks
Prolonged abstinence is identified by a negative response to the question, "Since 2 weeks after your TQD, have you smoked any tobacco, even a puff, for 7 consecutive days or at least once each week on 2 consecutive weeks?"
Measured: week 24
Heavy Drinking Days at End of Treatment
Heavy drinking is defined as 5 standard alcohol drinks or greater for men and 4 standard alcohol drinks or greater for women. The number of heavy drinking days per month was determined using the timeline follow-back method.
Measured: week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2011Mar 2014

First posted4 May 2011 (estimated)
Study startJun 2011
Primary completionJan 2014
Study completionMar 2014

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 (2)Papers the sponsor has linked to this study.
Other trials for SmokingStudies 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: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01347112
Sponsor's protocol ID: 10-008559
Other IDs: 10-008309
Status last verified: Jan 2018
First submitted: 2 May 2011
Last updated: 5 Feb 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Hurt RT, Ebbert JO, Croghan IT, Schroeder DR, Hurt RD, Hays JT. Varenicline for tobacco-dependence treatment in alcohol-dependent smokers: A randomized controlled trial. Drug Alcohol Depend. 2018 Mar 1;184:12-17. doi: 10.1016/j.drugalcdep.2017.11.017. Epub 2018 Jan 2.
PubMed 29324248
Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
PubMed 37142273

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Varenicline Treatment for Active Alcoholic Smokers
ClinicalTrials.gov ID: NCT01347112
Acronym / sponsor ID: 10-008559
Conditions: Smoking, Tobacco Dependence, Alcohol Dependence
Keywords: smoking, tobacco dependence, alcohol dependence
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Study start: Jun 2011
Primary completion: Jan 2014 (actual)
Study completion: Mar 2014 (actual)
First posted: 4 May 2011 (estimated)
Results: Posted 30 May 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Varenicline	Active comparator	Drug: Vareniclinevarenicline 1.0 mg twice daily for 12 weeks
Sugar Pil	Placebo comparator	Drug: placeboVarenicline look alike sugar pill twice 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 (8 listed)

Male or non-pregnant female cigarette smokers 18-years-of-age or older and reporting smoking at least an average of 10 cigarettes per day for the past year;
Subject is alcohol dependence based on DSM IV criteria as assessed by the Mini-International Neuropsychiatric Interview (MINI) and the physician investigator;3
Subject is currently drinking alcoholic beverages as assessed by the physician investigator;
Subject is a female subject of non-childbearing potential or a female subject of childbearing potential - who is using contraceptives and has a negative pregnancy test result;
Subject must be able to complete all the study visits;

Key exclusion criteria (15 listed)

Subject is a female who is 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);
Subject has another household member in study;
Known allergy to varenicline;
Subject is currently (in previous 30 days) using other behavioral or pharmacologic tobacco cessation program (i.e., behavioral therapy, nicotine replacement therapy, clonidine, varenicline, bupropion SR, nortriptyline or doxepin) and unwilling or unable to discontinue use;
Subject has an unstable medical condition as determined by the physician investigator;

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: chantix, champix, varenicline tartratevarenicline 1.0 mg dose, twice daily for 12 weeks	Drug	Varenicline
placeboAlso: sugar pillsugar pill twice daily for 12 weeks	Drug	Sugar Pil

Primary outcome

Prolonged Smoking Abstinence at End of 12 Weeks of Varenicline Treatment
Time frame: 12 weeks
Prolonged smoking abstinence will be identified by a negative response to the question, "Since 2 weeks after your TQD, have you smoked any tobacco, even a puff, for 7 consecutive days or at least once each week on 2 consecutive weeks?"

2 secondary outcomes

Prolonged Abstinence at 24 Weeks
Time frame: week 24
Heavy Drinking Days at End of Treatment
Time frame: week 12

Results and safety

Results posted to the registry on 30 May 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Varenicline	16	12
Sugar Pill	17	5

Primary outcome: Prolonged Smoking Abstinence at End of 12 Weeks of Varenicline Treatment

Time frame: 12 weeks. Number. Unit: participants

Measure	Varenicline n = 16	Sugar Pil n = 17
Value	6	1

Varenicline vs Sugar Pil: p = 0.034, Fisher Exact

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Varenicline	0 of 16 (0%)	5 of 16 (31.3%)	Not reported
Sugar Pill	0 of 17 (0%)	2 of 17 (11.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 29324248Hurt RT, Ebbert JO, Croghan IT, Schroeder DR, Hurt RD, Hays JT. Varenicline for tobacco-dependence treatment in alcohol-dependent smokers: A randomized controlled trial. Drug Alcohol Depend. 2018 Mar 1;184:12-17. doi: 10.1016/j.drugalcdep.2017.11.017. Epub 2018 Jan 2.
Derived from this study: PubMed 37142273Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
Varenicline for tobacco-dependence treatment in alcohol-dependentLink provided by the sponsor.

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Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
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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.

Richard D. Hurt, MD principal investigator

Mayo Clinic

2 sites 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 Smoking and Tobacco Dependence, run by Mayo Clinic at 2 sites 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 8 inclusion and 15 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 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 May 2014). 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?

Prolonged Smoking Abstinence at End of 12 Weeks of Varenicline Treatment (time frame: 12 weeks). 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 NCT01347112, which also lists 2 linked publications.

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 5 Feb 2018.