Neurocognitive Functioning Following The PROMETA® Treatment Protocol In Subjects With Alcohol Dependence
NCT ID: NCT00570388
Last Updated: 2008-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2007-03-31
2008-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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2
Subjects in the active Prometa group will receive flumazenil, gabapentin, and hydroxyzine per the Prometa Protocol.
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.
1
Subjects in the "placebo group" will receive placebo flumazenil, gabapentin, and hydroxyzine
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
75 Years
ALL
No
Sponsors
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Institute of Addiction Medicine
OTHER
Responsible Party
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Institute of Addiction Medicine
Principal Investigators
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Jenny J Starosta, PhD
Role: PRINCIPAL_INVESTIGATOR
Institute of Addiction Medicine
Joseph Volpicelli, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Institute of Addiction Medicine
Locations
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Institute of Addiction Medicine
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Mason BJ. Treatment of alcohol-dependent outpatients with acamprosate: a clinical review. J Clin Psychiatry. 2001;62 Suppl 20:42-8.
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.
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.
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.
Srisurapanont M, Jarusuraisin N. Opioid antagonists for alcohol dependence. Cochrane Database Syst Rev. 2005 Jan 25;(1):CD001867. doi: 10.1002/14651858.CD001867.pub2.
Stewart SA. The effects of benzodiazepines on cognition. J Clin Psychiatry. 2005;66 Suppl 2:9-13.
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.
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.
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.
Other Identifiers
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WIRB Protocol Number: 20062166
Identifier Type: -
Identifier Source: secondary_id
WIRB Study Number: 1085483
Identifier Type: -
Identifier Source: secondary_id
WIRB Invest. Number: 128549
Identifier Type: -
Identifier Source: secondary_id
20062166
Identifier Type: -
Identifier Source: org_study_id
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