Varenicline Treatment of Alcohol Dependence in Smokers

NCT01553136 | Completed Phase 2 Results DMC

• 2 other identifiers: 11060085981R01AA020388-01A1
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Alcoholism; Alcohol Abuse; Smoking; Alcohol Drinking

Keywords

alcohol-related disorders; Cholinergic Drugs; varenicline; Chantix

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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).

  8 weeks

Secondary Outcomes (2)

• Smoking Abstinence

  Weeks 13-16

• Drinking Related Consequences

  End of treatment (Week 17)

Study Arms (2)

Sugar pill

PLACEBO COMPARATOR

Drug: Varenicline

Varenicline

ACTIVE COMPARATOR

Drug: Varenicline

Interventions

Varenicline DRUG

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

Also known as: Chantix

Sugar pill; Varenicline

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Yale University: lead
• Columbia University: collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (2)

Connecticut Mental Health Center - Substance Abuse Treatment Unit

New Haven, Connecticut, 06511, United States

Location

Parallax Center

New York, New York, 10016, United States

Location

Related Publications (2)

• 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.

  PMID: 30817018 DERIVED

• 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.

  PMID: 29261824 DERIVED

MeSH Terms

Conditions

Alcoholism; Smoking; Alcohol Drinking; Alcohol-Related Disorders

Interventions

Varenicline

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Stephanie Samples O'Malley, PhD, Professor of Psychiatry
• Organization: Yale University

stephanie.omalley@yale.edu

(203) 974-7590

Study Officials

• Stephanie O'Malley, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

• Allen Zweben, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2012
• First Posted: March 13, 2012
• Study Start: September 1, 2012
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: March 6, 2020
• Results First Posted: February 12, 2018

Record last verified: 2018-10

Locations

US (2)