Baclofen for Treating Anxiety and Alcoholism

NCT01751386 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 13004013-AA-0040
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Total Amount of Alcohol Consumed During the Alcohol Self Administration (ASA) Session

  Amount of alcohol was measured as the number of mini-drinks each participant decided to drink (0-8 mini-drinks). The alcohol content of each mini-drink was calculated based on the participants' total body water, and was designed to raise the blood alcohol concentration by 0.015 g/dL.

  2 hours

Study Arms (2)

Baclofen

EXPERIMENTAL

Baclofen 10 mg t.i.d.

Drug: Baclofen

Placebo

PLACEBO COMPARATOR

Placebo t.i.d.

Other: Placebo

Interventions

Baclofen DRUG

Baclofen

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (8)

• 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. doi: 10.1159/000084161. Epub 2005 Feb 28.

  PMID: 15741745 BACKGROUND

• 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. doi: 10.1093/alcalc/37.5.504.

  PMID: 12217947 BACKGROUND

• 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. doi: 10.1016/s0002-9343(01)01088-9. No abstract available.

  PMID: 11893350 BACKGROUND

• 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). 2015 Jan;232(1):233-43. doi: 10.1007/s00213-014-3652-9. Epub 2014 Jun 29.

  PMID: 24973894 BACKGROUND

• 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.

  PMID: 23262301 BACKGROUND

• 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.

  PMID: 22244707 BACKGROUND

• Farokhnia M, Schwandt ML, Lee MR, Bollinger JW, Farinelli LA, Amodio JP, Sewell L, Lionetti TA, Spero DE, Leggio L. Biobehavioral effects of baclofen in anxious alcohol-dependent individuals: a randomized, double-blind, placebo-controlled, laboratory study. Transl Psychiatry. 2017 Apr 25;7(4):e1108. doi: 10.1038/tp.2017.71.

  PMID: 28440812 RESULT

• Richardson RS, Farokhnia M, Vendruscolo LF, Leggio L. Plasma concentrations of the inflammatory adipokine lipocalin-2 are not affected by chronic alcohol exposure in rats or acute alcohol administration in people with alcohol use disorder. Am J Drug Alcohol Abuse. 2025;51(6):730-740. doi: 10.1080/00952990.2025.2582563. Epub 2025 Dec 2.

  PMID: 41329966 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Alcoholism; Alcohol Drinking; Anxiety Disorders; Behavior, Addictive

Interventions

Baclofen

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Drinking Behavior; Behavior; Compulsive Behavior; Impulsive Behavior

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Lorenzo Leggio
• Organization: National Institute on Alcohol Abuse and Alcoholism

lorenzo.leggio@mail.nih.gov

+1 301 435 9398

Study Officials

• Lorenzo Leggio, M.D.

  National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2012
• First Posted: December 18, 2012
• Study Start: December 3, 2012
• Primary Completion: August 17, 2016
• Study Completion: August 17, 2016
• Last Updated: September 18, 2017
• Results First Posted: August 16, 2017

Record last verified: 2017-07-17

Data Sharing

• IPD Sharing: Will share

Locations

US (1)