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Protocol Details

A Double-Blind, Placebo-Controlled, Randomized Human Laboratory Pilot Study of baclofen in Anxious Alcoholics

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

13-AA-0040

Sponsoring Institute

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 21
Max Age: 65

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Addiction;
Cue-Induced Craving;
Craving;
Anxiety;
Alcohol Consumption

Recruitment Keyword(s)

None

Condition(s)

Alcoholism;
Alcohol Dependence;
Alcohol Drinking Related Problems;
Alcohol Drinking;
Anxiety Disorder

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Drug: baclofen
Other: Placebo

Supporting Site

National Institute on Alcohol Abuse and Alcoholism

Background:

- baclofen is a drug used to control muscle stiffness in people with neurological diseases. Some studies suggest that baclofen may reduce alcohol craving and use. It helps to reduce anxiety in alcoholics, which in turn can help to reduce cravings. Researchers want to see if baclofen can be a safe and effective treatment for alcoholics who have high anxiety levels.

Objectives:

- To see if baclofen is safe and helpful for people who have alcoholism and high anxiety levels.

Eligibility:

- Individuals between 21 and 65 years of age who have been diagnosed with alcoholism and anxiety issues.

- Participants must not be taking anti-anxiety medication.

Design:

- Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Tests of alcohol dependency and anxiety levels will also be given.

- Participants will be divided into two groups. One group will take baclofen. The other group will have a placebo.

- About 1 week after the screening visit, participants will have a study visit. They will answer questions about their behavior and mood. They will then start to take either baclofen or a placebo. Participants will take the study drug three times a day, every day.

- After 1 week on the study drug, participants will have an overnight stay at the National Institutes of Health. They will have blood tests and answer questions about mood and behavior. They will also have tests that involve choosing to drink alcohol and answering more questions about cravings.

- Participants will stop taking their study drug over a 3-day period.

- A final follow-up visit will be required 1 week after the overnight study visit. Participants will receive information about other alcohol abuse treatment programs.

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Eligibility

INCLUSION CRITERIA:

-Must be male or female between 21 and 65 years old (inclusive).

-Participants must meet criteria for current DSM-IV-TR diagnosis of alcohol dependence, supported by the Structured Clinical Interview for DSM-IV-TR Axis I Disorders (SCID).

-Participants must have a Trait STAI > 39.

-Participants must be in good health as confirmed by medical history, physical examination, ECG, blood/urine lab tests.

-Females must be postmenopausal for at least one year, surgically sterile, or practicing an effective method of birth control before entry and throughout the study; have a negative urine pregnancy test at each visit. Reliable methods of birth control include oral contraceptives or Norplant ; barrier methods such as diaphragms with contraceptive jelly, cervical caps with contraceptive jelly, condoms with contraceptive foam, or intrauterine devices; a partner with a vasectomy; or abstinence from intercourse.

EXCLUSION CRITERIA:

-Individuals expressing interest in treatment for alcoholism and/or anxiety.

-Pregnancy or breast feeding women or not using an adequate form of birth control

-Unable to provide a negative urine drug screen.

-Individuals diagnosed with a current substance dependence diagnosis, other than alcohol or nicotine.

-Meet DSM-IV Axis I criteria for a lifetime diagnosis of schizophrenia, bipolar disorder, or other psychoses.

-An active illness within the past 6 months of Visit 1 that meet the DSM-IV criteria for a diagnosis of Major Depressive Disorder (MDD). Subjects with a history of attempted suicide will be excluded.

-Clinically significant medical abnormalities (i.e., unstable hypertension, clinically significant ECG abnormalities, Creatinine greater than or equal to 2 mg/dL). Although baclofen has demonstrated a safe profile when administered to alcoholic individuals with liver cirrhosis, including those with Hepatitis C, this study employs the oral administration of alcohol. Therefore, individuals with clinically significant liver problems will be excluded, i.e. liver cirrhosis, AST or ALT > 5 times the upper normal limit (UNL), and individuals with Hepatitis B and C.

-Current use of psychotropic medications that cannot be discontinued and that may have an effect on alcohol consumption (thus confounding the results of the study) or that may interact with baclofen. Specifically, contraindicated medications will include: naltrexone, acamprosate, alcohol dehydrogenase inhibitors, topiramate, gabapentin, ondansetron, benzodiazepines, beta-blockers, H2-blockers, and alpha-1 blockers.

-Medical contraindications for use of baclofen.

-A history of adverse reaction or hypersensitivity to baclofen.

-Participants who have significant alcohol withdrawal symptoms, defined as a CIWA-Ar > 8.

-History of epilepsy or alcohol-related seizures.


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Citations:

Addolorato G, Abenavoli L, Leggio L, Gasbarrini G. How many cravings? Pharmacological aspects of craving treatment in alcohol addiction: a review. Neuropsychobiology. 2005;51(2):59-66. Epub 2005 Feb 28.

Addolorato G, Caputo F, Capristo E, Domenicali M, Bernardi M, Janiri L, Agabio R, Colombo G, Gessa GL, Gasbarrini G. baclofen efficacy in reducing alcohol craving and intake: a preliminary double-blind randomized controlled study. Alcohol Alcohol. 2002 Sep-Oct;37(5):504-8.

Addolorato G, Caputo F, Capristo E, Janiri L, Bernardi M, Agabio R, Colombo G, Gessa GL, Gasbarrini G. Rapid suppression of alcohol withdrawal syndrome by baclofen. Am J Med. 2002 Feb 15;112(3):226-9.

Leggio L, Zywiak WH, Edwards SM, Tidey JW, Swift RM, Kenna GA. A preliminary double-blind, placebo-controlled randomized study of baclofen effects in alcoholic smokers. Psychopharmacology (Berl). 2014 Jun 29. [Epub ahead of print]

Leggio L, Zywiak WH, McGeary JE, Edwards S, Fricchione SR, Shoaff JR, Addolorato G, Swift RM, Kenna GA. A human laboratory pilot study with baclofen in alcoholic individuals. Pharmacol Biochem Behav. 2013 Feb;103(4):784-91. doi: 10.1016/j.pbb.2012.11.013. Epub 2012 Dec 19.

Leggio L, Ferrulli A, Zambon A, Caputo F, Kenna GA, Swift RM, Addolorato G. baclofen promotes alcohol abstinence in alcohol dependent cirrhotic patients with hepatitis C virus (HCV) infection. Addict Behav. 2012 Apr;37(4):561-4. doi: 10.1016/j.addbeh.2011.12.010. Epub 2011 Dec 27.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Lorenzo Leggio, M.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
BG 10-CRC RM 1-5428
10 CENTER DR
BETHESDA MD 20814
(301) 435-9398
leggiol@mail.nih.gov

Lorenzo Leggio, M.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
BG 10-CRC RM 1-5428
10 CENTER DR
BETHESDA MD 20814
(301) 435-9398
leggiol@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:

NCT01751386

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