Back to resultsLofexidine for Opiate Withdrawal - 1
Primary Purpose
Opioid-Related Disorders
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Lofexidine
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-Related Disorders focused on measuring opiate dependence
Eligibility Criteria
Inclusion Criteria: Male or female as least 18 yrs of age & above with a current dependence on heroin, morphine or hydromorphone according to DSM4 criteria; subject ; voluntarily given consent and signed informed consent; females using appropriate birth control method. Exclusion Criteria: Additional criteria available during screening at the site
Sites / Locations
- UCLA Medical Center
- Columbia University
- Philadelphia Veterans Medical Center
Outcomes
Primary Outcome Measures
Opiate withdrawal symptoms
Potential Abuse Liability
Secondary Outcome Measures
Full Information
NCT ID
NCT00032942
First Posted
April 5, 2002
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
Britannia Pharmaceuticals Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00032942
Brief Title
Lofexidine for Opiate Withdrawal - 1
Official Title
A Phase III Placebo-Controlled, Double-Blind Multi-Site Trial of Lofexidine for Opiate Withdrawal
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
October 2004 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
Britannia Pharmaceuticals Ltd.
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate lofexidine for opiate withdrawal.
Detailed Description
An 11 day inpatient placebo-controlled, double-blind study of 96 opiate dependent, treatment seeking individuals randomized to 2 medication groups: lofexidine and placebo to be conducted in inpatient units at 3 treatment sites.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders
Keywords
opiate dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
66 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lofexidine
Primary Outcome Measure Information:
Title
Opiate withdrawal symptoms
Title
Potential Abuse Liability
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female as least 18 yrs of age & above with a current dependence on heroin, morphine or hydromorphone according to DSM4 criteria; subject ; voluntarily given consent and signed informed consent; females using appropriate birth control method.
Exclusion Criteria:
Additional criteria available during screening at the site
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Montgomery, R.N.
Organizational Affiliation
National Institute on Drug Abuse (NIDA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10023
Country
United States
Facility Name
Philadelphia Veterans Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Lofexidine for Opiate Withdrawal - 1
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