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Baclofen for Treating Anxiety and Alcoholism

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01751386
First Posted: December 18, 2012
Last Update Posted: September 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Alcohol Abuse and Alcoholism (NIAAA) )
  Purpose

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.

Condition Intervention Phase
Alcoholism Alcohol Dependence Alcohol Drinking Related Problems Alcohol Drinking Anxiety Disorder Drug: Baclofen Other: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Double-Blind, Placebo-Controlled, Randomized Human Laboratory Pilot Study of Baclofen in Anxious Alcoholics

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC) ( National Institute on Alcohol Abuse and Alcoholism (NIAAA) ):

Primary Outcome Measures:
  • Total Amount of Alcohol Consumed During the Alcohol Self Administration (ASA) Session [ Time Frame: 2 hours ]
    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.


Enrollment: 39
Study Start Date: December 3, 2012
Study Completion Date: August 17, 2016
Primary Completion Date: August 17, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Baclofen
Baclofen 10 mg t.i.d.
Drug: Baclofen
Placebo Comparator: Placebo
Placebo t.i.d.
Other: Placebo

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01751386


Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Principal Investigator: Lorenzo Leggio, M.D. National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  More Information

Additional Information:
Publications:

Responsible Party: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier: NCT01751386     History of Changes
Other Study ID Numbers: 130040
13-AA-0040 ( Other Identifier: The National Institutes of Health )
First Submitted: December 13, 2012
First Posted: December 18, 2012
Results First Submitted: July 17, 2017
Results First Posted: August 16, 2017
Last Update Posted: September 18, 2017
Last Verified: July 17, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The NIH Biomedical Translational Research Information System

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute on Alcohol Abuse and Alcoholism (NIAAA) ):
Addiction
Cue-Induced Craving
Craving
Anxiety
Alcohol Consumption

Additional relevant MeSH terms:
Anxiety Disorders
Alcoholism
Alcohol Drinking
Mental Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Drinking Behavior