Prescription Opioid Addiction Treatment Study (POATS)

Completed · Phase 3

Conditions studied: Opiate Dependence, Substance-related Disorders, Opioid-related Disorders

In brief

The purpose of this study is to determine whether treatment outcome for subjects dependent on prescription opioid analgesics can be improved by adding individual drug counseling to the prescription of buprenorphine/naloxone with standard medical management. This will be examined during: a) an initial four-week treatment with taper; b) a 12-week stabilization treatment for those who do not respond successfully to the initial treatment; and c) a long-term follow-up assessment at 1.5 years, 2.5 years, and 3.5 years after treatment.

Key facts

Study ID

NCT00316277

Run by

Mclean Hospital

People needed

653

Starts

2006-05-01

Expected to finish

2013-01-01

Last updated by the study team

2013-02-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years old or older
• Physically dependent on opioids
• Meet DSM-IV criteria for opioid dependence

You may not qualify if…

• Known allergy or sensitivity to buprenorphine or naloxone
• Unstable psychiatric disorder
• Pregnant or lactating females
• Liver function test results greater than 5 times the upper limit of normal range

Where it is running

• Integrated Substance Abuse Programs — Los Angeles, California, United States
• San Francisco General Hospital — San Francisco, California, United States
• East Indiana Treatment Center — Lawrenceburg, Indiana, United States
• McLean Hospital, Alcohol and Drug Abuse Treatment Program — Belmont, Massachusetts, United States
• North Shore - Long Island Jewish Health Systems — Glen Oaks, New York, United States
• Bellevue Hospital Center — New York, New York, United States
• St. Luke's Roosevelt Hospital Center — New York, New York, United States
• ADAPT, Inc. — Roseburg, Oregon, United States
• Behavioral Health Services of Pickens County — Pickens, South Carolina, United States
• Homeward Bound, Inc. — Dallas, Texas, United States
• Providence Behavioral Health Service — Everett, Washington, United States
• Chestnut Ridge Hospital — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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