Back to resultsFeasibility Study of Take-Home LAAM Medication - 3
Primary Purpose
Opioid-Related Disorders
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
LAAM
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-Related Disorders focused on measuring opiate, dependence
Eligibility Criteria
Inclusion Criteria: meets DSM-IV criteria for opiate dependence. M/F, 18 years or older. Certified for LAAm treatment by a physician. Able to understand english. Willing to provide names, addresses, and numbers of 3 relatives who can aid in patient location for follow-up visits. Exclusion Criteria: Hypertensive to LAAM. Pregnant or nursing women. Female of childbearing potential who refuses to use an acceptable form of birth control. Clinically significant abnormality in hematology, blood work, or UA, ETOH and/or sedative/hypnotic dependence according to DSM-IV criteria. Medical or psychiatric illness which would jeopardize safe study participation.
Sites / Locations
- Friends Research Institute
Outcomes
Primary Outcome Measures
Drug use
Retention
Increased prosocial behaviors
Decreased frequency of HIV related behavior
Secondary Outcome Measures
Full Information
NCT ID
NCT00000300
First Posted
September 20, 1999
Last Updated
October 31, 2017
Sponsor
University of California, Los Angeles
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00000300
Brief Title
Feasibility Study of Take-Home LAAM Medication - 3
Official Title
Feasibility Study of Take-Home LAAM Medication
Study Type
Interventional
2. Study Status
Record Verification Date
March 1995
Overall Recruitment Status
Completed
Study Start Date
March 1995 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to test therapeutic benefits of take-home LAAM. (1) Do subjects with take-home LAAM availability show increased clinical responsibility over subjects without; (2) Do subjects with take-home LAAM attempt diversion when random recall and other diversion safeguards are used; (3) Does treatment response correlate with background or drug use variables at intake, discharge, or during treatment?
Detailed Description
1-Year study, participant will be randomly assigned to one of two groups: One will have the opportunity to earn take-home doses by turning in a designated number of clean urines. Two will not have the opportunity to earn take-home doses. Clinic visits three times per week. Urine sample given at each visit.
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 4
Allocation
Randomized
Enrollment
0 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
LAAM
Primary Outcome Measure Information:
Title
Drug use
Title
Retention
Title
Increased prosocial behaviors
Title
Decreased frequency of HIV related behavior
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:
meets DSM-IV criteria for opiate dependence. M/F, 18 years or older. Certified for LAAm treatment by a physician. Able to understand english. Willing to provide names, addresses, and numbers of 3 relatives who can aid in patient location for follow-up visits.
Exclusion Criteria:
Hypertensive to LAAM. Pregnant or nursing women. Female of childbearing potential who refuses to use an acceptable form of birth control. Clinically significant abnormality in hematology, blood work, or UA, ETOH and/or sedative/hypnotic dependence according to DSM-IV criteria. Medical or psychiatric illness which would jeopardize safe study participation.
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
Feasibility Study of Take-Home LAAM Medication - 3
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