Clinical trial NCT01553136: Varenicline Treatment of Alcohol Dependence in Smokers
Official title: 1/2-Multi-site Study: Varenicline Treatment of Alcohol Dependent Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcoholism
Alcohol Abuse
Smoking
Alcohol Drinking
Keywords: alcohol-related disorders
Cholinergic Drugs
varenicline
Chantix
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Columbia University
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2012-03-13
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
  * 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).

Primary outcomes:
measure: Percentage of Heavy Drinking Days During the Last 8 Weeks of Treatment
timeFrame: weeks 9-12
measure: Percentage of Heavy Drinking Days During the Last 8 Weeks of Treatment
timeFrame: weeks 13-16
measure: Percentage of Heavy Drinking Days During the Last 8 Weeks of Treatment
timeFrame: 8 weeks
Secondary outcomes:
measure: Smoking Abstinence
timeFrame: Weeks 13-16
measure: Drinking Related Consequences
timeFrame: End of treatment (Week 17)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Connecticut Mental Health Center - Substance Abuse Treatment Unit
state: Connecticut
city: New York
country: United States
facility: Parallax Center
state: New York
Study officials:
affiliation: Yale University
name: Stephanie O'Malley, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Allen Zweben, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.