NCT00000246

Brief Summary

The purpose of this study is to verify the hypothesis that the benzodiazepine antagonist, flumazenil, will reduce acute benzodiazepine withdrawal.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 1993

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 1993

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 1994

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 1994

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

September 20, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 1999

Completed
Last Updated

September 8, 2016

Status Verified

September 1, 2016

Enrollment Period

1.9 years

First QC Date

September 20, 1999

Last Update Submit

September 6, 2016

Conditions

Substance-Related Disorders

Keywords

Substance-Related Disorders

Outcome Measures

Primary Outcomes (1)

  • Benzodiazepine withdrawal severity

Interventions

FlumazenilDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Please contact site for information.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Yale University, Psychiatry

New Haven, Connecticut, 06519, United States

Location

Related Publications (1)

  • Woods, et al., Soc Neuroscience Abstracts 21: 2098, 1995.

    BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Flumazenil

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinonesBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Scott Woods, M.D.

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 1999

First Posted

September 21, 1999

Study Start

January 1, 1993

Primary Completion

December 1, 1994

Study Completion

December 1, 1994

Last Updated

September 8, 2016

Record last verified: 2016-09

Locations

US(1)