Prometa Protocol for Alcohol Dependence

This study has been completed.

Study NCT00262639 Information provided by Medical University of South Carolina

First Received on December 5, 2005. Last Updated on December 9, 2009 History of Changes

Results First Received: July 6, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Alcohol Dependence
Interventions:	Drug: Flumazenil and Gabapentin Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Low CIWA Flumazenil/Gabapentin	2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
Low CIWAar Placebo	20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
High CIWAar Placebo	20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
High CIWAar Flumazenil/Gabapentin	2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.

Participant Flow: Overall Study

	Low CIWA Flumazenil/Gabapentin	Low CIWAar Placebo	High CIWAar Placebo	High CIWAar Flumazenil/Gabapentin
STARTED	18	26	9	7
COMPLETED	18	26	9	7
NOT COMPLETED	0	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
Low CIWAar Placebo	No text entered.
Low CIWAar Flumazenil/Gabapentin	No text entered.
High CIWAar Placebo	No text entered.
High CIWAar Flumazenil/Gabapentin	No text entered.

Baseline Measures

	Low CIWAar Placebo	Low CIWAar Flumazenil/Gabapentin	High CIWAar Placebo	High CIWAar Flumazenil/Gabapentin	Total
Number of Participants [units: participants]	18	26	9	7	60
Age [units: participants]
<=18 years	0	0	0	0	0
Between 18 and 65 years	18	26	9	7	60
>=65 years	0	0	0	0	0
Age [units: years] Mean ± Standard Deviation	47.2 ± 11.2	44.1 ± 11.9	50.3 ± 8.5	46.7 ± 5.6	46.1 ± 10.6
Gender [units: participants]
Female	4	6	3	1	14
Male	14	20	6	6	46
Region of Enrollment [units: participants]
United States	18	26	9	7	60

Outcome Measures

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1. Primary:

Percent Subjects Completely Abstinent [ Time Frame: 16 week trial ]

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2. Primary:

Percent Days Abstinent [ Time Frame: Weeks 1 to 6, 10 and 14 ]

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3. Primary:

Alcohol Withdrawal Scores (CIWAar) [ Time Frame: Day 1 Day 2 Week 1 ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

4. Secondary:

Sleep [ Time Frame: Weeks 1 to 6, 10 and 14 ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

5. Secondary:

Acoustic Startle Response [ Time Frame: Day 1, Day 3, Week 1 ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

6. Secondary:

Regional Brain Activity on fMRI [ Time Frame: Week 2 ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Raymond F. Anton, M.D.
Organization: Medical University of South Carolina
phone: 843-792-1226
e-mail: antonr@musc.edu

No publications provided

Responsible Party:	Raymond F. Anton, MD, Medical University of South Carolina
ClinicalTrials.gov Identifier:	NCT00262639 History of Changes
Other Study ID Numbers:	15844
Study First Received:	December 5, 2005
Results First Received:	July 6, 2009
Last Updated:	December 9, 2009
Health Authority:	United States: Institutional Review Board