Status:
COMPLETED
Varenicline to Reduce Alcohol Consumption in Heavy Drinkers
Lead Sponsor:
Vijay Ramchandani, Ph.D.
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol Drinking
Eligibility:
All Genders
21-60 years
Phase:
PHASE1
PHASE2
Brief Summary
This study will determine whether varenicline, a drug that acts on the brain's nicotine receptors and is used to help smokers stop smoking, will have an impact on alcohol self-administration. People ...
Detailed Description
Objective: Considerable clinical and experimental evidence in humans and animal models links nicotine use with heavy alcohol consumption. Varenicline, an alpha4beta2 (nicotinic) acetylcholine recepto...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Age 21 to 60 years of age.
- In good health.
- Drink a weekly average of 15 and 20 standard alcoholic drinks (12 gm ethanol/beverage), respectively, for women and men.
- Have a working phone number.
- EXCLUSION CRITERIA:
- Currently seeking help for an alcohol problem.
- Subjects with clinically significant alcohol withdrawal.
- More than thirty days of abstinence from alcohol in the ninety days prior to enrollment.
- A positive breath alcohol concentration (BrAC) at the first visit
- A history of major alcohol-related complications at any time, such as pancreatitis.
- Any serious cardiovascular condition or high risk factors, evidenced by any of the following:
- Current or past diagnosis of coronary artery disease (such as ischemia, angina, congestive heart failure, myocardial infarction) or peripheral arterial disease;
- Current or past diagnosis of diabetes, or casual glucose level \> 200 mg/dl;
- Elevated blood pressure (above 160/100) at screening,
- Elevated lipid levels: LDL \> 160 mg/dL, HDL \< 40 mg/dL for males or \< 45 mg/dL for females;
- Clinically significant ECG abnormalities or unstable arrhythmias.
- Contraindication(s) to take the study medication as listed in the package insert.
- Contraindication(s) to take the study medication as listed in the package insert.
- Psychiatric problems requiring clinical attention: a current or past diagnosis of major depression, panic disorder, eating disorders, post traumatic stress disorder, schizophrenia, bipolar disorder, or obsessive compulsive disorder. Individuals who report lifetime (past or current) history of suicidal ideation, suicide attempts or self injury.
- Recent (within the last two months) or regular use of illicit or non-prescribed psycho-active substances such as opiates, benzodiazepines, cocaine, PCP, methamphetamines/other psychostimulants or marijuana.
- Psycho-social instability (e.g. no fixed address, no reliable secondary person to contact in case of an emergency).
- Women who are lactating, are trying to become pregnant or who are not willing to practice safe and effective birth control.
- Moderate-to-severe renal impairment defined as estimated or measured creatinine clearance less than 30 mL/min.
- Use of bupropion or nicotine replacement therapy within 90 days of the protocol, inhibitors/substrates for renal cationic transporters, or medications contraindicated with ethanol.
- Exclusion criteria for MRI scanning, including metal in body (such as implants, pacemaker, prostheses, shrapnel, irremovable piercing), left-handedness, and claustrophobia.
- A history of violence or aggression, assessed as part of the clinical interview at screening visit.
Exclusion
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00695500
Start Date
June 1 2008
End Date
June 1 2015
Last Update
August 15 2016
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892