A Pilot Clinical Trial of Varenicline as a Treatment for Alcohol Dependence
Summary
Purpose: This is an outpatient, randomized, double-blinded, placebo-controlled study in which either varenicline (twice daily) or placebo will be administered over a 12 week study period to examine genetic influences on treatment response to varenicline for reduction of hazardous drinking.
Description
Hazardous alcohol use and alcohol use disorders (AUDs) are an area of large unmet medical needs. Although there has been some progress with pharmacotherapy for alcohol-dependent individuals, a critical need for the development of novel and additional therapeutic approaches remains. Pharmacotherapy development for AUDs as a therapeutic area has had several recent advancements, where clinically as well as commercially successful additions to available treatment options are available and several more are expected in the near future. Based on recent preclinical work, we believe that varenicline has potential to become one of the first among those newly evolving treatments.
In this study, participants with nicotine dependence will receive standard varenicline or placebo treatment over the recommended course of 12 weeks. Since our research question addresses whether alcohol drinking also diminishes with varenicline treatment, we will not ask participants to alter alcohol use; we will simply follow their use over time. Study visits will take place at the Ernest Gallo Clinic and Research Center. The procedures to be completed include vital signs, blood samples at screening and end of study, urine toxicology screening and the completion of standard questionnaires. No special facilities are required for these procedures. Group therapy (which is not a research procedure, but part of standard nicotine dependence treatment) will take place at the Gallo Center.
Study Design
Allocation: Randomized, Control: Placebo Control, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
Conditions
Smoking and Alcohol Abuse
Intervention
varenicline, placebo
Location
UCSF: Ernest Gallo Clinic and Research Center
Emeryville
California
United States
94608
Status
Recruiting
Source
University of California, San Francisco
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01011907
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
National Institute On Alcohol Abuse And Alcoholism (u.s.)
Component of the NATIONAL INSTITUTES OF HEALTH. It conducts research focused on improving the treatment and prevention of alcoholism and alcohol-related problems to reduce the health, social, and economic consequences of this disease. NIAAA, NIMH, and NIDA were created as coequal institutes within the Alcohol, Drug Abuse and Mental Health Administration in 1974. It was established within the NATIONAL INSTITUTES OF HEALTH in 1992.
Alcohol-induced Disorders
Disorders stemming from the misuse and abuse of alcohol.
Alcohol Withdrawal Seizures
A condition where seizures occur in association with ethanol abuse (ALCOHOLISM) without other identifiable causes. Seizures usually occur within the first 6-48 hours after the cessation of alcohol intake, but may occur during periods of alcohol intoxication. Single generalized tonic-clonic motor seizures are the most common subtype, however, STATUS EPILEPTICUS may occur. (Adams et al., Principles of Neurology, 6th ed, p1174)
National Institute On Drug Abuse (u.s.)
Component of the NATIONAL INSTITUTES OF HEALTH. It supports a comprehensive research portfolio that focuses on the biological, social, behavioral and neuroscientific bases of drug abuse on the body and brain as well as its causes, prevention, and treatment. NIDA, NIAAA, and NIMH were created as coequal institutes within the Alcohol, Drug Abuse and Mental Health Administration in 1974. It was established within the NATIONAL INSTITUTES OF HEALTH in 1992.
United States Substance Abuse And Mental Health Services Adminis...
An agency of the PUBLIC HEALTH SERVICE concerned with the overall planning, promoting, and administering of programs pertaining to substance abuse and mental health. It is commonly referred to by the acronym SAMHSA. On 1 October 1992, the United States Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA) became SAMHSA.
Clinical Trials
The Effect of Naltrexone and Varenicline on Alcohol-Mediated Smoking Lapse
The purpose of this study is to examine how medications thought to attenuate the effects of alcohol (naltrexone) and smoking cessation medications (varenicline) affect the ability to resis...
Smoking Cessation Treatment for Methadone Maintenance Patients
Patients in substance abuse treatment smoke four times more than non-substance abusers, and suffer high rates of tobacco-related disease and death. While many quit smoking treatments exis...
Alcohol and nicotine dependence are often co-morbid, with 85% of alcoholics also smoking. However, very little research has been conducted into the nature of this co-occurrence. Thus, the...
Varenicline Treatment in Alcohol and Nicotine Dependent Patients With Schizophrenia
The aim of the proposed pilot study is to find out whether varenicline (ChantixTM) treatment decreases alcohol use and smoking in patients with schizophrenia or schizoaffective disorder. V...
Varenicline Effects on Cue Reactivity and Smoking Reward/Reinforcement
The purpose of this study is to find out how varenicline works to help people quit smoking. Varenicline, also known as Chantix ™, is an FDA-approved medication that has been shown to hel...
PubMed Articles
A preliminary investigation of varenicline for heavy drinking smokers.
RATIONALE: Varenicline, an approved smoking cessation pharmacotherapy, also shows promise as a potential treatment for alcohol dependence. However, varenicline has not been tested in heavy drinkers, a...
RATIONALE: Treatment of the most widely abused drugs, nicotine and alcohol, is hampered by high rates of relapse. Varenicline tartrate, an α4β2 nicotinic receptor partial agonist, is currently presc...
Abstract Objective: A pooled analysis to evaluate the efficacy and safety of varenicline versus placebo for smoking cessation in Asian populations. A secondary objective was to compare the data to poo...
Varenicline is an effective and increasingly prescribed drug for smoking cessation, but has been associated with depressive symptoms and suicidal behavior. However, it remains unclear whether those ch...
Varenicline effects on craving, cue reactivity, and smoking reward.
RATIONALE: Varenicline is an α4β2 nicotinic acetylcholine receptor partial agonist that has been found to be effective for treating tobacco dependence. However, the subjective and behavioral mediato...
