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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 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

Find a Location

Who is running the clinical trial?

New York State Psychiatric InstituteLead Sponsor
475 Previous Clinical Trials
153,605 Total Patients Enrolled
17 Trials studying Alcoholism
1,368 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
811 Previous Clinical Trials
1,158,237 Total Patients Enrolled
428 Trials studying Alcoholism
778,307 Patients Enrolled for Alcoholism
john mariani, MDPrincipal InvestigatorNew York Psychiatric Institute
~1 spots leftby Jul 2024
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