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Benzodiazepine Antagonist

2 for Alcoholism

N/A
Waitlist Available
Led By Joseph Volpicelli, MD, PhD
Research Sponsored by Institute of Addiction Medicine
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 time frame: eight weeks
Awards & highlights

Study Summary

This study will test the safety and efficacy of the PROMETA® Treatment Protocol (which includes the benzodiazepine antagonist flumazenil) in reversing the neurocognitive impairment and this in turn will lead to improved ability to resist alcohol related cues and enhance involvement in psychosocial treatment.

Eligible Conditions
  • Alcoholism

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~eight weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and eight weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The measure is neurocognitive functioning as assessed by a battery of standardized neurocognitive tests that assess, executive functioning, verbal memory, general intelligence, and attention.
Secondary outcome measures
measures include, alcohol craving, subject retention, percent of abstinent days, percent of heavy drinking days, time to first heavy drinking day, and blood chemistries including liver enzymes, reports of side effects.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: 2Active Control1 Intervention
Subjects in the active Prometa group will receive flumazenil, gabapentin, and hydroxyzine per the Prometa Protocol.
Group II: 1Placebo Group1 Intervention
Subjects in the "placebo group" will receive placebo flumazenil, gabapentin, and hydroxyzine

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Who is running the clinical trial?

Institute of Addiction MedicineLead Sponsor
Joseph Volpicelli, MD, PhDPrincipal InvestigatorInstitute of Addiction Medicine
Jenny J Starosta, PhDPrincipal InvestigatorInstitute of Addiction Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Neurocognitive Functioning Following The PROMETA® Treatment Protocol In Subjects With Alcohol Dependence
2007. "Neurocognitive Functioning Following The PROMETA® Treatment Protocol In Subjects With Alcohol Dependence". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00570388.
~7 spots leftby Apr 2025
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