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A Randomized, Double-blind, Placebo Controlled Trial (RCT) of Varenicline to Reduce Alcohol Consumption in Heavy Drinkers
This study is currently recruiting participants.
Summary | Eligibility | Citations | Contacts
Summary
Number |
08-AA-0137 |
Sponsoring Institute |
National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
Recruitment Detail |
Type: Participants currently recruited/enrolled |
Referral Letter Required |
No |
Population Exclusion(s) |
Children |
Special Instructions |
Currently Not Provided |
Keywords |
Varenicline; |
Recruitment Keyword(s) |
Alcohol Use; |
Condition(s) |
Alcohol Drinking |
Investigational Drug(s) |
Varenicline (Chantix) |
Investigational Device(s) |
None |
Intervention(s) |
Drug: Varenicline |
Supporting Site |
|
People between 24 and 60 years of age who regularly consume alcoholic drinks (more than 15 drinks per week for women, and more than 20 drinks per week for men) may be eligible for this study. The study requires five outpatient visits and one overnight hospital admission at the NIH Clinical Center.
Participants undergo the following procedures:
Visit 1 (outpatient: 4-5 hours)
-Standard assessments, including vital signs measurements, breathalyzer test, blood and urine tests (including pregnancy test for females), questionnaires about mood, symptoms, alcohol use and smoking, if applicable
-Questionnaires about medical and psychological status
-Health assessment and assessment of alcohol drinking behavior
Visit 2 (outpatient: 8 hours)
-Standard assessments (see above)
-Computer-Assisted Self-infusion of Ethanol (CASE) session: Subjects will receive a priming intravenous infusion of alcohol. After 25 min, they will be allowed to give themselves additional exposures of alcohol over a period of 2 hours by pressing a button on a computer that controls the infusion pump.
Visit 3 (outpatient: 2 hours)
-Standard assessments
Visit 4 (outpatient: 8 hours)
-Standard assessments
-Brain functional magnetic resonance imaging scan (MRI). This test uses a magnetic field and radio waves to produce images of the brain. The patient lies on a table that can slide in and out of the scanner, wearing earplugs to muffle loud sounds that occur during the scanning process. Initial pictures are taken of the brain's structure and additional scans measure brain activity while the subject performs simple tasks.
- Alcohol Infusion. Subjects receive an intravenous infusion of alcohol while in the MRI scanner to measure the brain's response to alcohol.
Visit 5 (overnight)
-Standard assessments
-Repeat CASE session
-Interview about the subject's experiences participating in the protocol, including any symptoms and urges to drink
Visit 6 (outpatient)
-Standard assessments (without blood tests)
-Interview about participation in the study
Telephone follow-up
After 3 weeks, subjects are called to check on their symptoms and gather information on their drinking and, if applicable, smoking.
Eligibility
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.
Citations:
Contacts:
Principal Investigator |
Referral Contact |
For more information: |
| Vijay A. Ramchandani, Ph.D. National Institute on Alcohol Abuse and Alcoholism (NIAAA) National Institutes of Health Building 10 Room 2-2352 10 Center Drive Bethesda, Maryland 20892 (301) 402-8527 vijayr@mail.nih.gov |
Vijay A. Ramchandani, Ph.D. National Institute on Alcohol Abuse and Alcoholism (NIAAA) National Institutes of Health Building 10 Room 2-2352 10 Center Drive Bethesda, Maryland 20892 (301) 402-8527 vijayr@mail.nih.gov |
Patient Recruitment and Public Liaison Office Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 prpl@mail.cc.nih.gov |
Clinical Trials Number:
NCT00695500
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