Feasibility Study of Take-Home LAAM Medication - 3

This study has been completed.

First Received: September 20, 1999 Last Updated: November 3, 2005 History of Changes

Sponsor:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00000300

Purpose

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?

Condition	Intervention	Phase
Opioid-Related Disorders	Drug: LAAM	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized
Official Title:	Feasibility Study of Take-Home LAAM Medication

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

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

Estimated Enrollment:	0
Study Start Date:	March 1995

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000300

Locations

United States, California
Friends Research Institute
Los Angeles, California, United States, 90025

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Walter Ling, M.D.

Friends Research Institute, Inc.

More Information

No publications provided

Study ID Numbers:	NIDA-09260-3, P50-09260-3
Study First Received:	September 20, 1999
Last Updated:	November 3, 2005
ClinicalTrials.gov Identifier:	NCT00000300 History of Changes
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Physiological Effects of Drugs
Central Nervous System Depressants
Disorders of Environmental Origin
Narcotics
Opioid-Related Disorders
Pharmacologic Actions
Methadyl Acetate
Mental Disorders

Sensory System Agents
Therapeutic Uses
Substance-Related Disorders
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 08, 2010