Status:
TERMINATED
Varenicline and Alcohol in Inpatient Addictions Program (IAP)
Lead Sponsor:
Mayo Clinic
Conditions:
Alcoholism
Nicotine Dependence
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 h...
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 2...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01169610
Start Date
January 1 2011
End Date
June 1 2013
Last Update
March 20 2019
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905