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Varenicline and Alcohol in Inpatient Addictions Program (IAP)

Primary Purpose

Alcoholism, Nicotine Dependence

Status

Terminated

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Varenicline

About this trial

This is an interventional treatment trial for Alcoholism focused on measuring Alcohol, Smoking

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Subjects will be eligible for enrollment if they:

Are > 18 and < 70 years of age
Are admitted to the inpatient addiction program (IAP) in the Generose Building at Saint Marys Hospital
Have been diagnosed with alcohol dependence based on DSM-IV-TR criteria and confirmed by Psychiatric Research Interview for Substance and Mental Disorders (PRISM)
Smoke at least 10 cigarettes/day for ≥ 6 months
Are able to participate fully in all aspects of the study
Have been provided with, understand, and have signed the informed consent; and
Agree to identify collateral individuals for contact purposes to facilitate follow-up appointments.

Patients will be excluded from participation if they:

Meet DSM-IV criteria of schizophrenia or other non-affective psychotic disorder
Have had psychotic symptoms within the past month
Have an Axis I disorder requiring new pharmacotherapy
Have a predominant Axis II disorder
Have used an investigational drug within 30 days of enrollment
Have started Naltrexone or Acamprosate during this same IAP admission
Have a history (past 3 months) of drug abuse (excluding caffeine and marijuana)
Have active suicidality as measured by screening questions from the Columbia-Suicide Severity Rating Scale (C-SSRS), (Posner 2008) outlined below:
a. "Yes" response to questions 1, 2, or 3 with significant intensity level endorsed as: i. Frequency: score of 4 or 5 ii. Duration: score of 3, 4 or 5 iii. Controllability: score of 0, 4, or 5 iv. Deterrents: score of 0, 4 or 5 v. Reasons for Ideation: score of 1, 2, 3, 4 or 5 b. "Yes" response to question 4 c. "Yes" response to question 5
Have a history of medically serious suicide attempt within 5 years
Have a history of any major cardiovascular events including arrhythmias, congestive heart failure, unstable angina, acute MI or coronary angioplasty
Are pregnant, lactating, or of child bearing potential, likely to become pregnant during the medication phase and not willing to use a reliable form of contraception. Reliable forms of contraception include diaphragm or condom (with spermicidal), injections, intrauterine device [IUD], surgical sterilization and abstinence;
Have clinically significant acute or chronic progressive or unstable neurologic, hepatic, renal, cardiovascular, respiratory or metabolic disease
Have another household member or relative participating in the study
Have a known allergy to varenicline
Are individuals, in the investigators opinion, unable to comply with study procedures
Are unable to provide written informed consent in English
Are on hemodialysis or have a history of kidney disease.

Patients will be excluded from participation in the MR spectroscopy portion of the study if they have:

Claustrophobia
A history of major head trauma with loss of consciousness > 5 minutes or skull fracture
A history of previous neurological event (e.g., epilepsy, stroke, transient ischemic attack)
Implanted metal objects (e.g., pacemakers; aneurysm clips; metal prostheses, joints, rods, or plates)
Contraindication to MRI scanning.

Sites / Locations

Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Varenicline

Arm Description

Outcomes

Primary Outcome Measures

Continuous Alcohol Abstinence

No consumption of alcohol (not even a single drink) during the specified interval of time. This will be a self-reported outcome.

Heavy Drinking Days

Number of drinking days > 5 drinks/day for men and > 4 drink/day for women. This will be a self-reported outcome.

Secondary Outcome Measures

7-day Point Prevalence Smoking Abstinence

Negative response to the question, "Have you used any type of tobacco, even a puff, in the past 7 days." This will be a self-reported outcome biochemically-confirmed with exhaled-air carbon monoxide (CO) < 8 parts per million (ppm) during the medication phase.

Prolonged Smoking Abstinence

Self-reported all tobacco abstinence since two weeks after target quit date (TQD) which will be during their 28-day stay in the IAP on day 8 of varenicline therapy. Negative response to the question, "Have you used any type of tobacco, even a puff, for 7 consecutive days or at least once each week on two consecutive weeks since xx/xx/xxxx?" Note: xx/xx/xxxx corresponds to the date two weeks after the target quit date (TQD). Biochemically-confirmed abstinence at the visit for which prolonged abstinence is being obtained.

Tolerability of Varenicline

Tolerability will be defined by the number of adverse events experienced by patients.

Full Information

NCT ID

NCT01169610

First Posted

July 22, 2010

Last Updated

March 5, 2019

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT01169610

Brief Title

Varenicline and Alcohol in Inpatient Addictions Program (IAP)

Official Title

A 24-week Open-Label Feasibility Trial of Varenicline for Alcoholic Cigarette Smokers

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Terminated

Study Start Date

January 2011 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The overall hypothesis of this line of research is that varenicline will decrease alcohol consumption and tobacco use and will increase alcohol and tobacco abstinence rates. In order to explore this hypothesis, the investigators will conduct a two-phase study: 1) an open label pilot study investigating the effect of varenicline on reduction of and abstinence from alcohol and tobacco; and 2) an optional MR spectroscopy to investigate whether glutamate and other brain metabolites correlate to measures of alcohol craving severity and/or subsequent varenicline treatment response.

Detailed Description

The goal of this proposal is to explore the potential efficacy of varenicline for reducing alcohol consumption among alcohol-dependent cigarette smokers. The hypothesis for the current study is that 24 weeks of varenicline will increase alcohol abstinence rates among smokers and decrease alcohol consumption among patients receiving inpatient addiction treatment for alcoholism. The investigators will also explore whether varenicline has a beneficial effect on tobacco abstinence rates in this population of tobacco users. The investigators will conduct an open-label pilot study to determine clinical efficacy and employ neuroimaging techniques to evaluate how glutamate and other brain metabolites correlate to measures of alcohol craving severity and/or subsequent varenicline treatment response. The investigators will enroll 20 subjects receiving treatment in the Mayo Clinic Inpatient Addictions Program (IAP) and compare outcomes with patients participating in a similar 6-month open-label study of acamprosate. The Primary aims of this study are: To obtain preliminary evidence of efficacy of varenicline (0.5 mg once daily for 3 days, 0.5 mg twice daily for days 4-7, 1 mg twice a day for remaining 23 weeks) for increasing continuous alcohol abstinence rates at 3 and 6 months among patients with alcohol and tobacco dependence who have completed treatment at the Mayo Clinic IAP. To obtain preliminary evidence of efficacy of varenicline (0.5 mg once daily for 3 days, 0.5 mg twice daily for days 4-7, 1 mg twice a day for remaining 23 weeks) for decreasing the number of heavy drinking days (> 5 drinks/day for men and > 4 drink/day for women) at 3 and 6 months among patients with alcohol and tobacco dependence who have completed treatment at the Mayo Clinic IAP. To obtain preliminary data on baseline and baseline to endpoint change in CSF volume corrected concentrations of the dorsal striatal glutamate, glutamate + glutamine, and NAA measures through MR spectroscopy before and after 30 days of varenicline treatment among patients with alcohol and tobacco dependence who have completed treatment at the Mayo Clinic IAP. Secondary aims: To obtain preliminary evidence of efficacy of varenicline (0.5 mg once daily for 3 days, 0.5 mg twice daily for days 4-7, 1 mg twice a day for remaining 23 weeks) for increasing the 7-day point prevalence smoking abstinence rates and prolonged smoking abstinence at 3 and 6 months among patients with alcohol and tobacco dependence who have completed treatment at the Mayo Clinic IAP. To assess the tolerability of varenicline (0.5 mg once daily for 3 days, 0.5 mg twice daily for days 4-7, 1 mg twice a day for remaining 23 weeks).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcoholism, Nicotine Dependence

Keywords

Alcohol, Smoking

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Varenicline

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Varenicline

Other Intervention Name(s)

Chantix

Intervention Description

Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.

Primary Outcome Measure Information:

Title

Continuous Alcohol Abstinence

Description

No consumption of alcohol (not even a single drink) during the specified interval of time. This will be a self-reported outcome.

Time Frame

Two years

Title

Heavy Drinking Days

Description

Number of drinking days > 5 drinks/day for men and > 4 drink/day for women. This will be a self-reported outcome.

Time Frame

Two years

Secondary Outcome Measure Information:

Title

7-day Point Prevalence Smoking Abstinence

Description

Time Frame

Two years

Title

Prolonged Smoking Abstinence

Description

Time Frame

Two years

Title

Tolerability of Varenicline

Description

Tolerability will be defined by the number of adverse events experienced by patients.

Time Frame

Two years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Subjects will be eligible for enrollment if they: Are > 18 and < 70 years of age Are admitted to the inpatient addiction program (IAP) in the Generose Building at Saint Marys Hospital Have been diagnosed with alcohol dependence based on DSM-IV-TR criteria and confirmed by Psychiatric Research Interview for Substance and Mental Disorders (PRISM) Smoke at least 10 cigarettes/day for ≥ 6 months Are able to participate fully in all aspects of the study Have been provided with, understand, and have signed the informed consent; and Agree to identify collateral individuals for contact purposes to facilitate follow-up appointments. Patients will be excluded from participation if they: Meet DSM-IV criteria of schizophrenia or other non-affective psychotic disorder Have had psychotic symptoms within the past month Have an Axis I disorder requiring new pharmacotherapy Have a predominant Axis II disorder Have used an investigational drug within 30 days of enrollment Have started Naltrexone or Acamprosate during this same IAP admission Have a history (past 3 months) of drug abuse (excluding caffeine and marijuana) Have active suicidality as measured by screening questions from the Columbia-Suicide Severity Rating Scale (C-SSRS), (Posner 2008) outlined below: a. "Yes" response to questions 1, 2, or 3 with significant intensity level endorsed as: i. Frequency: score of 4 or 5 ii. Duration: score of 3, 4 or 5 iii. Controllability: score of 0, 4, or 5 iv. Deterrents: score of 0, 4 or 5 v. Reasons for Ideation: score of 1, 2, 3, 4 or 5 b. "Yes" response to question 4 c. "Yes" response to question 5 Have a history of medically serious suicide attempt within 5 years Have a history of any major cardiovascular events including arrhythmias, congestive heart failure, unstable angina, acute MI or coronary angioplasty Are pregnant, lactating, or of child bearing potential, likely to become pregnant during the medication phase and not willing to use a reliable form of contraception. Reliable forms of contraception include diaphragm or condom (with spermicidal), injections, intrauterine device [IUD], surgical sterilization and abstinence; Have clinically significant acute or chronic progressive or unstable neurologic, hepatic, renal, cardiovascular, respiratory or metabolic disease Have another household member or relative participating in the study Have a known allergy to varenicline Are individuals, in the investigators opinion, unable to comply with study procedures Are unable to provide written informed consent in English Are on hemodialysis or have a history of kidney disease. Patients will be excluded from participation in the MR spectroscopy portion of the study if they have: Claustrophobia A history of major head trauma with loss of consciousness > 5 minutes or skull fracture A history of previous neurological event (e.g., epilepsy, stroke, transient ischemic attack) Implanted metal objects (e.g., pacemakers; aneurysm clips; metal prostheses, joints, rods, or plates) Contraindication to MRI scanning.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark Frye, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

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Varenicline and Alcohol in Inpatient Addictions Program (IAP)

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