Neurocognitive Functioning Following The PROMETA® Treatment Protocol In Subjects With Alcohol Dependence

January 15, 2008 updated by: Institute of Addiction Medicine
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The principal aim of this study is to extend our evaluation of the PROMETA® Treatment Protocol as a means to improve neurocognitive functioning in recently detoxified alcohol dependent subjects. For many alcohol dependent patients entering treatment, a range of neurocognitive deficits are present that not only had adverse effects on the patient's ability to function and think clearly but these deficits also impair the process of addiction treatment. For example, alcohol dependent subjects typically experience high levels of alcohol craving in the early stages of treatment. The patient is left with the choice of relieving craving by drinking alcohol to provide immediate relief of craving symptoms or abstaining from alcohol to obtain long-term benefits from recovery of the complications from excessive drinking. We have previously shown in open label trials that the PROMETA® Treatment Protocol helps stimulant abusers in the early stages of recovery, have relatively low rates of relapse to stimulant use. It is not clear if the Protocol is effective because of less urges to use stimulants or the ability to resist these urges is improved from a recovery of Neurocognitive functioning. The present proposal extends our previous research by comparing the efficacy of the PROMETA® Treatment Protocol in a double blind placebo controlled trial using a new population of substance abusers (alcohol dependent subjects) and assessing the effects of the PROMETA® Treatment Protocol on neurocognitive functioning, particularly those aspects of functioning that affect the ability to make decisions that have important long-term benefits.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Joseph Volpicelli, MD, PhD
  • Phone Number: 215-248-6025
  • Email: volpj@aol.com

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19118
        • Recruiting
        • Institute of Addiction Medicine
        • Contact:
        • Contact:
          • Joseph Volpicelli, MD, PhD
          • Phone Number: 215-248-6025
          • Email: volpj@aol.com
        • Principal Investigator:
          • Jenny J Starosta, PhD
        • Principal Investigator:
          • Joseph Volpicelli, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient must meet DSM-IV criteria for current diagnosis of alcohol dependence.
  • In the past 30 days, patient had an average of >15 standard alcohol drinks/week with at least one day of five or more drinks.
  • Patient must have successfully completed detoxification from alcohol (abstinent for three consecutive days). As evidenced by self-report or three negative breathalyzer reading and a CIWA-Ar score less than 6.
  • Patient understands and signs the consent.

Exclusion Criteria:

  • Patients with a current DSM-IV diagnosis of any substance dependence other than alcohol, nicotine, or cannabis.
  • Patients with a current or past history of DSM-IV diagnosis of Panic Disorder
  • Evidence of benzodiazepine use in the past 15 days, determined by self-report and/or by a urine drug screen
  • Patients with a seizure disorder being managed with a benzodiazepine or for whom a benzodiazepine is being considered
  • Patients who are currently being treated with psychotropic medications, including disulfiram, naltrexone, or acamprosate at the time of study entry.
  • Patients with a history of unstable or serious medical illness, including need for benzodiazepines.
  • Known severe physical or medical illnesses such as AIDS, active hepatitis,
  • Current severe psychiatric symptoms, e.g., psychosis, dementia, acute suicidal or homicidal ideation, mania or depression requiring newly initiated antidepressant or psychotropic therapy, or which would make it unsafe for the patient to participate in the opinion of the primary investigator.
  • Patients who have used investigational medication in the past 30 days.
  • Female patients who are pregnant, nursing, or not using a reliable method of contraception.
  • Patients with a condition that would make intravenous administration of medications difficult (e.g. absence of suitable peripheral veins).
  • Have a known or hypersensitivity to medication components of PROMETA®TM
  • Have been treated with PROMETA® for any reason currently or in the past year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2
Subjects in the active Prometa group will receive flumazenil, gabapentin, and hydroxyzine per the Prometa Protocol.
Drug: Prometa Treatment Program

Day 1-3•Hydroxyzine HCL 50 mg and multivitamins with minerals po one hour before flumazenil infusion. Flumazenil infusion.

Day 1•Gabapentin 300 mg po 9PM w/ hydroxyzine HCL 50 mg PRN for sleep.

Day 2•Gabapentin 600 mg po 9PM w/ hydroxyzine HCL 50 mg PRN

Day 3•Gabapentin 900 mg po 9PM w/ hydroxyzine HCL 50 mg PRN

Days 4 through 28•Gabapentin 1200 mg po 9 PM

Days 29 through 31•Gabapentin 900 mg po 9 PM

Days 32 through 34•Gabapentin 600 mg po 9 PM

Days 35 through 38•Gabapentin 300 mg po 9 PM

Flumazenil Dosing Schedule

2 mg flumazenil is given as a slow IV push. Subjects in the "placebo group" will receive placebo flumazenil, gabapentin, and hydroxyzine; subjects in the active group will receive flumazenil, gabapentin, and hydroxyzine per protocol.
Placebo Comparator: 1
Subjects in the "placebo group" will receive placebo flumazenil, gabapentin, and hydroxyzine
Drug: Prometa Treatment Program

Day 1-3•Hydroxyzine HCL 50 mg and multivitamins with minerals po one hour before flumazenil infusion. Flumazenil infusion.

Day 1•Gabapentin 300 mg po 9PM w/ hydroxyzine HCL 50 mg PRN for sleep.

Day 2•Gabapentin 600 mg po 9PM w/ hydroxyzine HCL 50 mg PRN

Day 3•Gabapentin 900 mg po 9PM w/ hydroxyzine HCL 50 mg PRN

Days 4 through 28•Gabapentin 1200 mg po 9 PM

Days 29 through 31•Gabapentin 900 mg po 9 PM

Days 32 through 34•Gabapentin 600 mg po 9 PM

Days 35 through 38•Gabapentin 300 mg po 9 PM

Flumazenil Dosing Schedule

2 mg flumazenil is given as a slow IV push. Subjects in the "placebo group" will receive placebo flumazenil, gabapentin, and hydroxyzine; subjects in the active group will receive flumazenil, gabapentin, and hydroxyzine per protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome measure is neurocognitive functioning as assessed by a battery of standardized neurocognitive tests that assess, executive functioning, verbal memory, general intelligence, and attention.
Time Frame: Time Frame: Eight Weeks
Time Frame: Eight Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary outcome 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.
Time Frame: Eight Weeks
Eight Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Addiction Medicine

Investigators

  • Principal Investigator: Jenny J Starosta, PhD, Institute of Addiction Medicine
  • Principal Investigator: Joseph Volpicelli, MD, PhD, Institute of Addiction Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Study Completion (Anticipated)

September 1, 2008

Study Registration Dates

First Submitted

December 6, 2007

First Submitted That Met QC Criteria

December 7, 2007

First Posted (Estimate)

December 10, 2007

Study Record Updates

Last Update Posted (Estimate)

January 16, 2008

Last Update Submitted That Met QC Criteria

January 15, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20062166
  • WIRB Protocol Number: 20062166
  • WIRB Study Number: 1085483
  • WIRB Invest. Number: 128549

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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