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Neurobiology of Opioid Dependence: 1 - 1

Primary Purpose

Opioid-Related Disorders

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lamotrigine
Sponsored by
Yale University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-Related Disorders focused on measuring opioid disorders

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Please contact site for information.

Sites / Locations

  • VA Connecticut Healthcare System

Outcomes

Primary Outcome Measures

Behavioral, subjective, measures of naloxone-precipitated opiate withdrawal
Phsyiological, neuroendocrine measures of naloxone-precipitated opiate withdrawal

Secondary Outcome Measures

Full Information

First Posted
September 20, 1999
Last Updated
August 5, 2015
Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00000192
Brief Title
Neurobiology of Opioid Dependence: 1 - 1
Official Title
Neurobiology of Opioid Dependence: 1
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Withdrawn
Study Start Date
January 1993 (undefined)
Primary Completion Date
January 1998 (Actual)
Study Completion Date
January 1998 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effects of lamotrigine on naloxone-precipitated opiate withdrawal.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders
Keywords
opioid disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lamotrigine
Primary Outcome Measure Information:
Title
Behavioral, subjective, measures of naloxone-precipitated opiate withdrawal
Title
Phsyiological, neuroendocrine measures of naloxone-precipitated opiate withdrawal

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Please contact site for information.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc I Rosen, M.D.
Organizational Affiliation
VA Connecticut Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Connecticut Healthcare System
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9800147
Citation
Rosen MI, Pearsall HR, Kosten TR. The effect of lamotrigine on naloxone-precipitated opiate withdrawal. Drug Alcohol Depend. 1998 Oct 1;52(2):173-6. doi: 10.1016/s0376-8716(98)00057-x.
Results Reference
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Neurobiology of Opioid Dependence: 1 - 1

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