Recruiting

PROMETA® Treatment

Sponsor:

Institute of Addiction Medicine

Code:

NCT00570388

Conditions

Alcohol Dependence

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Prometa Treatment Program

Study Details

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.

Conditions

Alcohol Dependence

Study ID

NCT00570388

Start date

Mar, 2007

Status verified date

Jan, 2008

Completion date

Sep, 2008

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 2

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

placebo comparator: 1

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

Interventions

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Jenny J Starosta, PhD

215-248-60252evolve@gmail.com

Joseph Volpicelli, MD, PhD

215-248-6025volpj@aol.com

Locations

Institute of Addiction Medicine

Recruiting

Philadelphia, Pennsylvania, United States, 19118

Contacts

Jenny J Starosta, PhD

215-248-60252evolve@gmail.com

Joseph Volpicelli, MD, PhD

215-248-6025volpj@aol.com

Principal Investigator:

Jenny J Starosta, PhD

More Information

Sponsor

Institute of Addiction Medicine

Last update posted

Jan 16, 2008

Last verified

Jan, 2008

Keywords

  • Neurocognitive
  • Alcohol Dependence
  • Prometa
  • Prometa Protocol
  • Starosta

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Institute of Addiction Medicine on 2008-01-16.