AlcoholismPhase 2NCT01553136

Varenicline Treatment of Alcohol Dependence in Smokers

A Phase 2 study testing Varenicline in people with Alcoholism and Alcohol Abuse, run by Yale University 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

The purpose of this study is to determine whether varenicline is effective in the treatment of alcohol dependence in smokers. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Alcoholism, Alcohol Abuse, Smoking
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: 131 participants
Where: 2 sitesUnited States
Study dates: Sep 2012to May 2016
Phase: Phase 2
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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

are 18 - 70 years of age and seeking treatment of alcohol drinking;
meet DSM-IV TR Criteria for Alcohol Dependence
report smoking 100 cigarettes or more in their lifetime and currently smoke at least twice weekly on average in the past 90 days and have a urinary cotinine level of > 30ng/mL by semi-quantitative urinalysis or equivalent plasma cotinine level (> 6 ng/mL);
report heavy drinking on at least 2 days on average per week (i.e., ≥ 4 drinks on an occasion for women and ≥ 5 drinks for men) for the past 90 days and no more than 7 consecutive days of abstinence at intake.

Who cannot join

exhibit current, clinically significant physical disease or abnormality based on medical history, physical examination, or routine laboratory evaluation including:
any unexplained elevations in liver enzymes (i.e., transaminases, bilirubin)
clinically significant, unstable cardiovascular disease/uncontrolled hypertension
hepatic or renal impairment
severe obstructive pulmonary disease
diabetes mellitus requiring insulin or certain oral medications (i.e., sulfonylureas) and an A1C hemoglobin test score of > 7 for participants not prescribed these medications

Show all 22Show fewer

baseline systolic blood pressure higher than 150 mm Hg or diastolic blood pressure higher than 95 mm Hg
have a history of cancer (except treated basal cell or squamous cell carcinoma of the skin)
have a history of serious hypersensitivity reactions or skin reactions to varenicline;
exhibit serious psychiatric illness (i.e., schizophrenia, bipolar disorder, severe major depression, panic disorder, borderline personality disorder, organic mood or mental disorders by history or psychological examination
report current suicidal ideation (past 6 months) or lifetime hx of suicidal behavior assessed with the Columbia Suicide Severity Rating Scale 60; or risk for aggression using a cut-off of 15 or more on the Overt Aggression Scale - Modified Aggression Scale or 6 or more on the OAS-M Irritability Subscale 61.
have used any psychotropic drug in the past month, except individuals who are on a stable dose of a Selective Serotonin Reuptake Inhibitor for at least two months or who report occasional use of prescription sleep aids that they are willing to discontinue;
have a current DSM-IV diagnosis of drug dependence other than nicotine or alcohol
are at risk for an alcohol withdrawal syndrome as evidenced by:
a history of seizures, delirium, or hallucinations during alcohol withdrawal
a Clinical Institute Withdrawal Assessment scale 62 score of > 8,
report drinking to avoid withdrawal symptoms
have required medical treatment of alcohol withdrawal within the past 6 months
have used another investigational drug within 30 days or have used medications to treat alcohol (e.g., naltrexone, topiramate, acamprosate, disulfiram) or nicotine use (e.g., clonidine, varenicline, bupropion, nicotine replacement) in the past 3 months or intend to use these medications;prior use of nicotine replacement in situations where smoking is not permitted (e.g., planes) without the intention to quit smoking is not exclusionary;
intend to donate blood or blood products during the treatment phase of the study
have a Body Mass Index (calculated as weight in kilograms divided by the square of height in meters) less than 15 or greater than 39.99 or weight less than 45 kg;
are a female of childbearing potential who is pregnant, nursing, or not practicing effective contraception (oral, injectable, or implantable contraceptives, intrauterine device, or barrier method with spermicide).

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Connecticut Mental Health Center - Substance Abuse Treatment Unit
New Haven, Connecticut, 06511
Parallax Center
New York, New York, 10016

Other trials in United States

About this study

Official title: 1/2-Multi-site Study: Varenicline Treatment of Alcohol Dependent Smokers

The purpose of this study is to determine whether varenicline is effective in the treatment of alcohol dependence in smokers.

Read the detailed description

Building upon knowledge about the role of nicotinic acetylcholine receptors in alcohol drinking and smoking, varenicline, a smoking cessation treatment that targets these receptors, will be tested as a potential treatment for alcohol dependent smokers seeking alcohol treatment.

Conditions: Alcoholism, Alcohol Abuse, Smoking, Alcohol Drinking
Being tested: Varenicline
Keywords: alcohol-related disorders, Cholinergic Drugs, varenicline, Chantix
Medical subject headings: Alcoholism, Smoking, Alcohol Drinking, Alcohol-Related Disorders

What participants receive

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

VareniclineDrug
Also called Chantix
0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day

Study groups in NCT01553136
Study group	Role	What they receive
Sugar pill	Placebo comparator	Not described Receives: Drug: Varenicline
Varenicline	Active comparator	Not described Receives: Drug: Varenicline

What is being measured

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

Percentage of Heavy Drinking Days During the Last 8 Weeks of Treatment
The percentage of days of heavy drinking will be examined over the final 8 weeks of the study averaged by month (weeks 9-12 and weeks 13-16). A heavy drinking day is defined as 5 or more standard drinks for men and 4 or more standard drinks for women. A standard drink contains approximately 0.6 fluid ounces of pure alcohol.
Measured: weeks 9-12
Percentage of Heavy Drinking Days During the Last 8 Weeks of Treatment
The percentage of days of heavy drinking will be examined over the final 8 weeks of the study averaged by month (weeks 9-12 and weeks 13-16). A heavy drinking day is defined as 5 or more standard drinks for men and 4 or more standard drinks for women. A standard drink contains approximately 0.6 fluid ounces of pure alcohol.
Measured: weeks 13-16
Percentage of Heavy Drinking Days During the Last 8 Weeks of Treatment
The percentage of days of heavy drinking will be examined over the final 8 weeks of the study. A heavy drinking day is defined as 5 or more standard drinks for men and 4 or more standard drinks for women. A standard drink contains approximately 0.6 fluid ounces of pure alcohol. Presented here is the average of the 8 weeks (reported as week 17 originally).
Measured: 8 weeks

Secondary outcomes (2)

Smoking Abstinence
Smoking abstinence is defined by self-reported abstinence from smoking for the last four weeks of treatment (weeks 13-16) and a urine cotinine level less than 15ng/mL measured at week 17.
Measured: Weeks 13-16
Drinking Related Consequences
A self-report measure of negative consequences from drinking will be administered and the total score are analyzed. The ImBIBe, a measure of alcohol consequences based on the Drinker Inventory of Consequences (DRINC) was used. The DRINC total score has a range from 0-45, 45 being the highest score (or greatest number of negative consequences).
Measured: End of treatment (Week 17)

Timeline

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

Sep 2012May 2016

First posted13 Mar 2012 (estimated)
Study startSep 2012
Primary completionMay 2016
Study completionMay 2016

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 AlcoholismStudies of the same condition, open and under way.
More trials run by Yale UniversityThe 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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 131 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01553136
Sponsor's protocol ID: 1106008598
Other IDs: 1R01AA020388-01A1
Status last verified: Oct 2018
First submitted: 16 Feb 2012
Last updated: 6 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Bold KW, Zweben A, Fucito LM, Piepmeier ME, Muvvala S, Wu R, Gueorguieva R, O'Malley SS. Longitudinal Findings from a Randomized Clinical Trial of Varenicline for Alcohol Use Disorder with Comorbid Cigarette Smoking. Alcohol Clin Exp Res. 2019 May;43(5):937-944. doi: 10.1111/acer.13994. Epub 2019 Mar 21.
PubMed 30817018
O'Malley SS, Zweben A, Fucito LM, Wu R, Piepmeier ME, Ockert DM, Bold KW, Petrakis I, Muvvala S, Jatlow P, Gueorguieva R. Effect of Varenicline Combined With Medical Management on Alcohol Use Disorder With Comorbid Cigarette Smoking: A Randomized Clinical Trial. JAMA Psychiatry. 2018 Feb 1;75(2):129-138. doi: 10.1001/jamapsychiatry.2017.3544.
PubMed 29261824

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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All Alcoholism trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 1/2-Multi-site Study: Varenicline Treatment of Alcohol Dependent Smokers
ClinicalTrials.gov ID: NCT01553136
Acronym / sponsor ID: 1106008598
Conditions: Alcoholism, Alcohol Abuse, Smoking, Alcohol Drinking
Keywords: alcohol-related disorders, Cholinergic Drugs, varenicline, Chantix
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 131 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: Columbia University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study start: Sep 2012
Primary completion: May 2016 (actual)
Study completion: May 2016 (actual)
First posted: 13 Mar 2012 (estimated)
Results: Posted 12 Feb 2018

Clinical summary

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

The purpose of this study is to determine whether varenicline is effective in the treatment of alcohol dependence in smokers.

Detailed description

Study design

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

Arm	Type	Receives
Sugar pill	Placebo comparator	Drug: Varenicline
Varenicline	Active comparator	Drug: Varenicline

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

are 18 - 70 years of age and seeking treatment of alcohol drinking;
meet DSM-IV TR Criteria for Alcohol Dependence
report smoking 100 cigarettes or more in their lifetime and currently smoke at least twice weekly on average in the past 90 days and have a urinary cotinine level of > 30ng/mL by semi-quantitative urinalysis or equivalent plasma cotinine level (> 6 ng/mL);
report heavy drinking on at least 2 days on average per week (i.e., ≥ 4 drinks on an occasion for women and ≥ 5 drinks for men) for the past 90 days and no more than 7 consecutive days of abstinence at intake.

Key exclusion criteria (22 listed)

exhibit current, clinically significant physical disease or abnormality based on medical history, physical examination, or routine laboratory evaluation including:
have a history of cancer (except treated basal cell or squamous cell carcinoma of the skin)
have a history of serious hypersensitivity reactions or skin reactions to varenicline;
exhibit serious psychiatric illness (i.e., schizophrenia, bipolar disorder, severe major depression, panic disorder, borderline personality disorder, organic mood or mental disorders by history or psychological examination
report current suicidal ideation (past 6 months) or lifetime hx of suicidal behavior assessed with the Columbia Suicide Severity Rating Scale 60; or risk for aggression using a cut-off of 15 or more on the Overt Aggression Scale - Modified Aggression Scale or 6 or more on the OAS-M Irritability Subscale 61.

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: Chantix0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day	Drug	Sugar pill, Varenicline

Primary outcome

Percentage of Heavy Drinking Days During the Last 8 Weeks of Treatment
Time frame: weeks 9-12
The percentage of days of heavy drinking will be examined over the final 8 weeks of the study averaged by month (weeks 9-12 and weeks 13-16). A heavy drinking day is defined as 5 or more standard drinks for men and 4 or more standard drinks for women. A standard drink contains approximately 0.6 fluid ounces of pure alcohol.
Percentage of Heavy Drinking Days During the Last 8 Weeks of Treatment
Time frame: weeks 13-16
The percentage of days of heavy drinking will be examined over the final 8 weeks of the study averaged by month (weeks 9-12 and weeks 13-16). A heavy drinking day is defined as 5 or more standard drinks for men and 4 or more standard drinks for women. A standard drink contains approximately 0.6 fluid ounces of pure alcohol.
Percentage of Heavy Drinking Days During the Last 8 Weeks of Treatment
Time frame: 8 weeks
The percentage of days of heavy drinking will be examined over the final 8 weeks of the study. A heavy drinking day is defined as 5 or more standard drinks for men and 4 or more standard drinks for women. A standard drink contains approximately 0.6 fluid ounces of pure alcohol. Presented here is the average of the 8 weeks (reported as week 17 originally).

2 secondary outcomes

Smoking Abstinence
Time frame: Weeks 13-16
Drinking Related Consequences
Time frame: End of treatment (Week 17)

Results and safety

Results posted to the registry on 12 Feb 2018, 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	64	48
Sugar Pill	67	45

Primary outcome: Percentage of Heavy Drinking Days During the Last 8 Weeks of Treatment

Time frame: weeks 9-12. Mean (Standard Error). Unit: log transformed percentage of days

Measure	Varenicline n = 64	Placebo n = 67
Value	2.07 (0.23)	2.25 (0.20)

Primary outcome: Percentage of Heavy Drinking Days During the Last 8 Weeks of Treatment

Time frame: weeks 13-16. Mean (Standard Error). Unit: log transformed percentage of days

Measure	Varenicline n = 64	Placebo n = 67
Value	1.99 (0.22)	2.09 (0.21)

Primary outcome: Percentage of Heavy Drinking Days During the Last 8 Weeks of Treatment

Time frame: 8 weeks. Least squares mean (Standard Error). Unit: percentage of heavy drinking days

Measure	Varenicline n = 64	Placebo n = 67
Value	2.40 (0.21)	2.28 (0.21)

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Varenicline	2 of 64 (3.1%)	47 of 64 (73.4%)	0 of 64
Sugar Pill	0 of 67 (0%)	46 of 67 (68.7%)	0 of 67

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30817018Bold KW, Zweben A, Fucito LM, Piepmeier ME, Muvvala S, Wu R, Gueorguieva R, O'Malley SS. Longitudinal Findings from a Randomized Clinical Trial of Varenicline for Alcohol Use Disorder with Comorbid Cigarette Smoking. Alcohol Clin Exp Res. 2019 May;43(5):937-944. doi: 10.1111/acer.13994. Epub 2019 Mar 21.
Derived from this study: PubMed 29261824O'Malley SS, Zweben A, Fucito LM, Wu R, Piepmeier ME, Ockert DM, Bold KW, Petrakis I, Muvvala S, Jatlow P, Gueorguieva R. Effect of Varenicline Combined With Medical Management on Alcohol Use Disorder With Comorbid Cigarette Smoking: A Randomized Clinical Trial. JAMA Psychiatry. 2018 Feb 1;75(2):129-138. doi: 10.1001/jamapsychiatry.2017.3544.

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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.

Stephanie O'Malley, PhD principal investigator

Yale University

Allen Zweben, PhD principal investigator

Columbia University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Varenicline in people with Alcoholism and Alcohol Abuse, run by Yale University 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 4 inclusion and 22 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 6 Mar 2020. 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 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.

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 12 Feb 2018). 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?

Percentage of Heavy Drinking Days During the Last 8 Weeks of Treatment (time frame: weeks 9-12). The study lists 3 primary outcomes in all. 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 NCT01553136, 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 6 Mar 2020.