Feasibility Study of Take-Home LAAM Medication

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

1995-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Opioid-Related Disorders

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

opiate dependence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LAAM

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Walter Ling

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Walter Ling, M.D.

Role: PRINCIPAL_INVESTIGATOR

Friends Research Institute, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Friends Research Institute

Los Angeles, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P50DA009260

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P50-09260-3

Identifier Type: -