Evaluation of Lofexidine for Treatment of Opiate Withdrawal - 10
Primary Purpose
Opioid-Related Disorders
Status
Completed
Phase
Phase 1
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 opioid dependence
Eligibility Criteria
Inclusion Criteria: M/F ages 21-50. Meet DSM-IV criteria for opiate dependence. Agree to conditions of the study and sign informed consent. Exclusion Criteria: Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.
Sites / Locations
- Friends Research Institute
Outcomes
Primary Outcome Measures
Opiate withdrawal
Adverse effect measures
Craving of opiates
Liking of opiates
Efficacy of lofexidine
Euphoria
Secondary Outcome Measures
Full Information
NCT ID
NCT00000345
First Posted
September 20, 1999
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00000345
Brief Title
Evaluation of Lofexidine for Treatment of Opiate Withdrawal - 10
Official Title
Evaluation of Lofexidine for Treatment of Opiate Withdrawal
Study Type
Interventional
2. Study Status
Record Verification Date
September 1997
Overall Recruitment Status
Completed
Study Start Date
April 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to assess the safety of lofexidine in the treatment of opiate-dependent individuals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders
Keywords
opioid dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)
Enrollment
0 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lofexidine
Primary Outcome Measure Information:
Title
Opiate withdrawal
Title
Adverse effect measures
Title
Craving of opiates
Title
Liking of opiates
Title
Efficacy of lofexidine
Title
Euphoria
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
M/F ages 21-50. Meet DSM-IV criteria for opiate dependence. Agree to conditions of the study and sign informed consent.
Exclusion Criteria:
Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Ling, M.D.
Organizational Affiliation
Friends Research Institute, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Friends Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Lofexidine for Treatment of Opiate Withdrawal - 10
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