Protocol Number: 08-AA-0137

Title:

A Randomized, Double-blind, Placebo Controlled Trial (RCT) of Varenicline to Reduce Alcohol Consumption in Heavy Drinkers

Number:

08-AA-0137

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 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.

Sponsoring Institute:

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

-Age 24 to 60 years of age.

-In good health.

-Drink a weekly average of 20-40 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.

-Contraindication(s) to take the study medication as listed in the package insert.

-Current psychiatric problems requiring clinical attention: a current diagnosis of major depression, panic disorder, eating disorders, or history of schizophrenia, bipolar disorder, or obsessive compulsive disorder. Individuals who report suicidal ideation or who have a past history of suicide attempts.

-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.

Special Instructions:

Currently Not Provided

Keywords:

Varenicline

Alcohol

Recruitment Keyword(s):

Alcohol Use

Alcohol

Condition(s):

Alcohol Drinking

Investigational Drug(s):

Varenicline (Chantix)

Investigational Device(s):

None

Intervention(s):

Drug: Varenicline

Drug: Varenicline (Chantix)

Supporting Site:

National Institute on Alcohol Abuse and Alcoholism

Contact(s):

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

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Lachin JM, Matts JP, Wei LJ. Randomization in clinical trials: conclusions and recommendations. Control Clin Trials. 1988 Dec;9(4):365-74.

Wei LJ, Lachin JM. Properties of the urn randomization in clinical trials. Control Clin Trials. 1988 Dec;9(4):345-64. Erratum in: Controlled Clin Trials 1989 Mar;10(1):following 126.

Falk DE, Yi HY, Hiller-Sturmhšfel S. An epidemiologic analysis of co-occurring alcohol and tobacco use and disorders: findings from the National Epidemiologic Survey on Alcohol and Related Conditions. Alcohol Res Health. 2006;29(3):162-71.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Clinical Research Informatics, CC.

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