Feasibility Study of Take-Home LAAM Medication - 3

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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,...

Brief Summary

Official Title: “Feasibility Study of Take-Home LAAM Medication”

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?

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Primary Purpose: Treatment

Detailed Clinical Trial 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.

Intervention(s) in this Clinical Trial

  • Drug: LAAM

Outcome Measures for this Clinical Trial

Primary Measures

  • Drug use
  • Retention
  • Increased prosocial behaviors
  • Decreased frequency of HIV related behavior

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: National Institute on Drug Abuse (NIDA) NIH

Overall Clinical Trial Officials and Contacts

Walter Ling, M.D. Principal Investigator Friends Research Institute, Inc.  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00000300

Study ID Number: NIDA-09260-3

ClinicalTrials.gov Identifier: NCT00000300

Health Authority: United States: Federal Government

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00000300