NCT00000193

Brief Summary

The purpose of this study is to evaluate the effects of gamma hydroxybutyric on naloxone-precipitated opiate withdrawal.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 1993

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

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
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 1998

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 1998

Completed
1.7 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

August 7, 2015

Status Verified

August 1, 2015

Enrollment Period

5 years

First QC Date

September 20, 1999

Last Update Submit

August 5, 2015

Conditions

Opioid-Related Disorders

Keywords

Opioid disorders

Outcome Measures

Primary Outcomes (2)

  • Behavioral, subjective, measures of naloxone-preci

  • Phsyiological, neuroendocrine measures of naloxone

Interventions

Gamma hydroxybutyricDRUG

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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Sponsors & Collaborators

Study Sites (1)

VA Connecticut Healthcare System

New Haven, Connecticut, 06519, United States

Location

Related Publications (1)

  • Neuropsychopharmacology, 1996; 14(3) pp 187-193. Neruopsychopharmacology 1996; 14(3), 187-193

    BACKGROUND

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Marc I Rosen, M.D.

    VA Connecticut Healthcare System

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Masking
DOUBLE
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

January 1, 1998

Study Completion

January 1, 1998

Last Updated

August 7, 2015

Record last verified: 2015-08

Locations

US(1)