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

Primary Purpose

Alcohol Dependence

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Prometa Treatment Program

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring Neurocognitive, Alcohol Dependence, Prometa, Prometa Protocol, Starosta

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Institute of Addiction MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Subjects in the active Prometa group will receive flumazenil, gabapentin, and hydroxyzine per the Prometa Protocol.

Subjects in the "placebo group" will receive placebo flumazenil, gabapentin, and hydroxyzine

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00570388

First Posted

December 6, 2007

Last Updated

January 15, 2008

Sponsor

Institute of Addiction Medicine

1. Study Identification

Unique Protocol Identification Number

NCT00570388

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2008

Overall Recruitment Status

Unknown status

Study Start Date

March 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

September 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Institute of Addiction Medicine

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Dependence

Keywords

Neurocognitive, Alcohol Dependence, Prometa, Prometa Protocol, Starosta

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Subjects in the active Prometa group will receive flumazenil, gabapentin, and hydroxyzine per the Prometa Protocol.

Arm Title

Arm Type

Placebo Comparator

Arm Description

Subjects in the "placebo group" will receive placebo flumazenil, gabapentin, and hydroxyzine

Intervention Type

Drug

Intervention Name(s)

Prometa Treatment Program

Intervention Description

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.

Primary Outcome Measure Information:

Title

Time Frame

Time Frame: Eight Weeks

Secondary Outcome Measure Information:

Title

Time Frame

Eight Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jenny J Starosta, PhD

Phone

215-248-6025

2evolve@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Joseph Volpicelli, MD, PhD

Phone

215-248-6025

volpj@aol.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jenny J Starosta, PhD

Organizational Affiliation

Institute of Addiction Medicine

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Joseph Volpicelli, MD, PhD

Organizational Affiliation

Institute of Addiction Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institute of Addiction Medicine

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19118

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jenny J Starosta, PhD

Phone

215-248-6025

2evolve@gmail.com

First Name & Middle Initial & Last Name & Degree

Joseph Volpicelli, MD, PhD

Phone

215-248-6025

volpj@aol.com

First Name & Middle Initial & Last Name & Degree

Jenny J Starosta, PhD

First Name & Middle Initial & Last Name & Degree

Joseph Volpicelli, MD, PhD

12. IPD Sharing Statement

Citations:

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Citation

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PubMed Identifier

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Citation

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

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