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Pregabalin for Alcoholism (GABI2 Trial)

Phase 2

Waitlist Available

Led By john mariani, MD

Research Sponsored by New York State Psychiatric Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured weekly over the 8 weeks of the medication phase of the trial or length of each individual's participation

Awards & highlights

GABI2 Trial Summary

This trial will study whether pregabalin is effective in treating alcohol dependence in 50 outpatients. Participants must report drinking at least 4 days per week for the past 28 days.

Eligible Conditions

Alcoholism

GABI2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured weekly over the 8 weeks of the medication phase of the trial or length of each individual's participation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured weekly over the 8 weeks of the medication phase of the trial or length of each individual's participation

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured weekly over the 8 weeks of the medication phase of the trial or length of each individual's participation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in proportion of heavy drinking days

GABI2 Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PregabalinExperimental Treatment1 Intervention

Treatment with pregabalin administered in 75 mg and 100 capsules in dosages up to 600 mg per day for up to 8 weeks (including a 3 week titration run up) followed by a one week taper.

Group II: PlaceboPlacebo Group1 Intervention

Individuals will receive the placebo capsules that appear identical to the pregabalin capsules and will receive the same number of capsules.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pregabalin

2005

Completed Phase 4

~6110

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

New York State Psychiatric InstituteLead Sponsor

475 Previous Clinical Trials

153,857 Total Patients Enrolled

17 Trials studying Alcoholism

1,368 Patients Enrolled for Alcoholism

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH

799 Previous Clinical Trials

1,362,461 Total Patients Enrolled

422 Trials studying Alcoholism

985,158 Patients Enrolled for Alcoholism

john mariani, MDPrincipal InvestigatorNew York Psychiatric Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

May I join this medical research effort?

"This clinical study seeks participants aged 18-65 with a history of alcohol consumption within the past 28 days. Specifically, male enrollees must consume at least 5 servings and females 4 portions on four or more occasions per week to qualify."

Answered by AI

Is Pregabalin a relatively secure medication to take?

"Our team assigned Pregabalin a score of 2, as this is merely a Phase 2 trial and there are some indications that it may be safe but no evidence yet to support its efficacy."

Answered by AI

Are senior citizens above the age of 70 precluded from participating in this clinical experiment?

"This study is seeking individuals aged 18 and older, yet younger than 65 to participate."

Answered by AI

To what health issues is Pregabalin commonly prescribed?

"Pregabalin is a frequent therapeutic option for those suffering from fibromyalgia. Its utility, however, extends beyond this to encompass anxiety disorders, vitamin b12 shortages and spinal cord injuries as well."

Answered by AI

Are there any openings still available for this research project?

"Affirmative. The official record on clinicaltrials.gov confirms that recruitment for this medical study, which was first posted on January 11th 2021, is ongoing. At present, 50 patients are required to be enrolled from one medical centre."

Answered by AI

Approximately how many participants have signed up for this clinical research?

"That is correct. According to clinicaltrials.gov, this research trial initiated on the 11th of January 2021 and was recently updated on November 1st 2022. 50 patients will be accepted at one medical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pregabalin Trial for the Treatment of Alcohol Use Disorder

John Mariani MD 2021. "Pregabalin Trial for the Treatment of Alcohol Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04322305.