NCT00570388

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 10, 2007

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

January 16, 2008

Status Verified

January 1, 2008

First QC Date

December 6, 2007

Last Update Submit

January 15, 2008

Conditions

Alcohol Dependence

Keywords

NeurocognitiveAlcohol DependencePrometaPrometa ProtocolStarosta

Outcome Measures

Primary Outcomes (1)

  • 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: Eight Weeks

Secondary Outcomes (1)

  • 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.

    Eight Weeks

Study Arms (2)

2

ACTIVE COMPARATOR

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

Drug: Prometa Treatment Program

1

PLACEBO COMPARATOR

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

Drug: Prometa Treatment Program

Interventions

Prometa Treatment ProgramDRUG

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.

12

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Addiction Medicine

Philadelphia, Pennsylvania, 19118, United States

RECRUITING

Related Publications (13)

  • Matching alcoholism treatments to client heterogeneity: treatment main effects and matching effects on drinking during treatment. Project MATCH Research Group. J Stud Alcohol. 1998 Nov;59(6):631-9. doi: 10.15288/jsa.1998.59.631.

    PMID: 9811084BACKGROUND

  • Barker MJ, Greenwood KM, Jackson M, Crowe SF. Cognitive effects of long-term benzodiazepine use: a meta-analysis. CNS Drugs. 2004;18(1):37-48. doi: 10.2165/00023210-200418010-00004.

    PMID: 14731058BACKGROUND

  • Bates ME, Pawlak AP, Tonigan JS, Buckman JF. Cognitive impairment influences drinking outcome by altering therapeutic mechanisms of change. Psychol Addict Behav. 2006 Sep;20(3):241-53. doi: 10.1037/0893-164X.20.3.241.

    PMID: 16938062BACKGROUND

  • Girdler NM, Lyne JP, Wallace R, Neave N, Scholey A, Wesnes KA, Herman C. A randomised, controlled trial of cognitive and psychomotor recovery from midazolam sedation following reversal with oral flumazenil. Anaesthesia. 2002 Sep;57(9):868-76. doi: 10.1046/j.1365-2044.2002.02785.x.

    PMID: 12190751BACKGROUND

  • Mason BJ. Treatment of alcohol-dependent outpatients with acamprosate: a clinical review. J Clin Psychiatry. 2001;62 Suppl 20:42-8.

    PMID: 11584875BACKGROUND

  • Mason BJ, Goodman AM, Chabac S, Lehert P. Effect of oral acamprosate on abstinence in patients with alcohol dependence in a double-blind, placebo-controlled trial: the role of patient motivation. J Psychiatr Res. 2006 Aug;40(5):383-93. doi: 10.1016/j.jpsychires.2006.02.002. Epub 2006 Mar 20.

    PMID: 16546214BACKGROUND

  • Rupp CI, Fleischhacker WW, Drexler A, Hausmann A, Hinterhuber H, Kurz M. Executive function and memory in relation to olfactory deficits in alcohol-dependent patients. Alcohol Clin Exp Res. 2006 Aug;30(8):1355-62. doi: 10.1111/j.1530-0277.2006.00162.x.

    PMID: 16899038BACKGROUND

  • Singh N, Sharma A, Singh M. Possible mechanism of alprazolam-induced amnesia in mice. Pharmacology. 1998 Jan;56(1):46-50. doi: 10.1159/000028181.

    PMID: 9467187BACKGROUND

  • Srisurapanont M, Jarusuraisin N. Opioid antagonists for alcohol dependence. Cochrane Database Syst Rev. 2005 Jan 25;(1):CD001867. doi: 10.1002/14651858.CD001867.pub2.

    PMID: 15674887BACKGROUND

  • Stewart SA. The effects of benzodiazepines on cognition. J Clin Psychiatry. 2005;66 Suppl 2:9-13.

    PMID: 15762814BACKGROUND

  • Tapert SF, Ozyurt SS, Myers MG, Brown SA. Neurocognitive ability in adults coping with alcohol and drug relapse temptations. Am J Drug Alcohol Abuse. 2004 May;30(2):445-60. doi: 10.1081/ada-120037387.

    PMID: 15230085BACKGROUND

  • Uekermann J, Daum I, Schlebusch P, Wiebel B, Trenckmann U. Depression and cognitive functioning in alcoholism. Addiction. 2003 Nov;98(11):1521-9. doi: 10.1046/j.1360-0443.2003.00526.x.

    PMID: 14616178BACKGROUND

  • Zinn S, Stein R, Swartzwelder HS. Executive functioning early in abstinence from alcohol. Alcohol Clin Exp Res. 2004 Sep;28(9):1338-46. doi: 10.1097/01.alc.0000139814.81811.62.

    PMID: 15365304BACKGROUND

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Jenny J Starosta, PhD

    Institute of Addiction Medicine

    PRINCIPAL INVESTIGATOR

  • Joseph Volpicelli, MD, PhD

    Institute of Addiction Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenny J Starosta, PhD

CONTACT

215-248-60252evolve@gmail.com

Joseph Volpicelli, MD, PhD

CONTACT

215-248-6025volpj@aol.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 6, 2007

First Posted

December 10, 2007

Study Start

March 1, 2007

Study Completion

September 1, 2008

Last Updated

January 16, 2008

Record last verified: 2008-01

Locations

US(1)