Feasibility Study of Take-Home LAAM Medication - 3

Opioid-Related Disorders Clinical Trial

Official title:

Feasibility Study of Take-Home LAAM Medication

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000300
• Other study ID #: NIDA-09260-3
• Secondary ID: P50DA009260P50-0
• Status: Completed
• Phase: Phase 4
• First received: September 20, 1999
• Last updated: October 31, 2017
• Start date: March 1995

Study information

• Verified date: March 1995
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Opioid-Related Disorders

Intervention

Drug:
• LAAM

Locations

Country	Name	City	State
United States	Friends Research Institute	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drug use
Primary	Retention
Primary	Increased prosocial behaviors
Primary	Decreased frequency of HIV related behavior