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Pregabalin as Treatment for Alcohol Use Disorder

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ClinicalTrials.gov Identifier: NCT03256253
Recruitment Status : Active, not recruiting
First Posted : August 21, 2017
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
John Mariani MD, New York State Psychiatric Institute

Brief Summary:
The proposed protocol is an 8 week open label outpatient pilot trial of the safety and efficacy of pregabalin (Lyrica) in the treatment of alcohol use disorder. The primary objective of the study is to determine the efficacy of pregabalin in promoting alcohol abstinence among individuals with an alcohol use disorder.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Drug: Pregabalin Phase 2

Detailed Description:
The proposed protocol is an open label outpatient pilot trial of the safety and efficacy of pregabalin (Lyrica) in the treatment of alcohol use disorder. Pregabalin is commonly used for the treatment of pain issues such as fibromyalgia (chronic pain in your body), diabetic nerve pain, spinal cord injury nerve, and pain after shingles. We plan to enroll 20 participants in an 8-week trial.The ideal dosing, tolerability, and safety of pregabalin will be tested in outpatients with Alcohol Use Disorder (AUD). The primary objective of the study is to determine the efficacy of pregabalin in promoting alcohol abstinence among individuals with an alcohol use disorder.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: open label pilot study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Pilot Study of Pregabalin as Treatment for Alcohol Use Disorder
Actual Study Start Date : February 15, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol
Drug Information available for: Pregabalin

Arm Intervention/treatment
Experimental: pregabalin
pregabalin up to daily dose of 600 mg
Drug: Pregabalin
pregabalin up to 600 mg/day
Other Name: lyrica




Primary Outcome Measures :
  1. Maximum dose of pregabalin: [ Time Frame: over the cours of the 8 week trial or participants length of participation ]
    Defined as the highest amount of medication per day maintained for a 7 day period.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meets DSM-5 criteria for current alcohol use disorder
  • Reports drinking a minimum of 5 standard drinks for men or 4 standard drinks for women at least 4 days per week over the past 28 days
  • Between the ages of 18 and 65
  • Able to provide informed consent and comply with study procedures

Exclusion Criteria:

  • Subjects with any current psychiatric disorder as defined by DSM-5, other than AUD, that in the investigator's judgment might require intervention over the course of the study.
  • Subjects receiving psychotropic medication treatment
  • Evidence of moderate-to-severe alcohol withdrawal (CIWA-Ar > 13)
  • History of alcohol withdrawal seizures or alcohol withdrawal delirium
  • History of allergic reaction to candidate medication (pregabalin)
  • Pregnancy, lactation, or failure in females patients to use adequate contraceptive methods
  • Unstable physical disorders which might make participation hazardous
  • Subjects who have a current DSM-5 diagnosis of moderate or severe substance use disorder, with the exception of alcohol, nicotine and caffeine use disorders. A diagnosis of a mild substance use disorder will not be exclusionary, as long as the current primary substance use disorder is alcohol.
  • Are legally mandated to participate in alcohol use disorder treatment program
  • Cognitively impaired

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): NCT03256253


Locations
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United States, New York
Columbia Univeristy-STARS
New York, New York, United States, 10019
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
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Principal Investigator: john mariani, md new york psychiatric institute

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Responsible Party: John Mariani MD, Research psychiatrist, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT03256253     History of Changes
Other Study ID Numbers: 7491
First Posted: August 21, 2017    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.: No

Keywords provided by John Mariani MD, New York State Psychiatric Institute:
alcohol use disorder
alcohol abuse
treatment
lyrica

Additional relevant MeSH terms:
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Pregabalin
Disease
Alcohol Drinking
Alcoholism
Pathologic Processes
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs