Prescription Opioid Addiction Treatment Study (POATS)

February 1, 2013 updated by: Roger D. Weiss, Mclean Hospital

A Two-Phase Randomized Controlled Clinical Trial of Buprenorphine/Naloxone Treatment Plus Standard Medical Management or Enhanced Medical Management for Opioid Analgesic Dependence

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized 2-phase, open-label; multi-center study conducted in outpatient treatment settings. The main objective of this study is to identify an effective sublingual buprenorphine/naloxone treatment regimen for subjects dependent on prescription opioids. Phase 1 of this study will assess the prevailing one-month detoxification practice. This phase will assess the benefits of individual drug counseling in a short-term treatment paradigm. The second phase of this study will assess the benefit of individual drug counseling in a longer-term treatment paradigm for participants who did not respond successfully to the short-term buprenorphine/naloxone treatment. There is also a long-term follow-up assessment to determine outcomes at 1.5 years, 2.5 years, and 3.5 years after treatment.

Study Type

Interventional

Enrollment (Actual)

653

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90025
        • Integrated Substance Abuse Programs
      • San Francisco, California, United States, 94110
        • San Francisco General Hospital
    • Indiana
      • Lawrenceburg, Indiana, United States, 47025
        • East Indiana Treatment Center
    • Massachusetts
      • Belmont, Massachusetts, United States, 02478
        • McLean Hospital, Alcohol and Drug Abuse Treatment Program
    • New York
      • Glen Oaks, New York, United States, 11004
        • North Shore - Long Island Jewish Health Systems
      • New York, New York, United States, 10016
        • Bellevue Hospital Center
      • New York, New York, United States, 10019
        • St. Luke's Roosevelt Hospital Center
    • Oregon
      • Roseburg, Oregon, United States, 97470
        • ADAPT, Inc.
    • South Carolina
      • Pickens, South Carolina, United States, 29671
        • Behavioral Health Services of Pickens County
    • Texas
      • Dallas, Texas, United States, 75208
        • Homeward Bound, Inc.
    • Washington
      • Everett, Washington, United States, 98206
        • Providence Behavioral Health Service
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • Chestnut Ridge Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Buprenorphine/Nx with EMM
Behavioral: Enhanced Medical Management (EMM) of Prescription Opiate Abuse
Enhanced Medical Management in Phase 1 will consist of SMM plus two individual sessions with a counselor per week (45 minutes each) through Weeks 1-4, and one 45-minute counseling visit at Week 6 and at Week 8. And in Phase 2, EMM will consist of the SMM plus two individual sessions with a counselor per week (45 minutes each) during Weeks 1-6 and one individual session with a counselor per week (45 minutes each) during Weeks 7-12. In addition, participants in Phase 1 will receive BUP/NX at between 8 to 32mg/day; tapering to zero between weeks three and four. Those referred to Phase 2 will receive up to 32 mg/day for three months tapering to zero during month four.
Active Comparator: Buprenorphine/Nx with SMM
Behavioral: Standard Medical Management (SMM) of Prescription Opiate Abuse
Standard Medical Management in Phase 1 will consist of one hour-long initial visit; one individual 15-20 minute visit later in Week 1; one individual 15-20 minute visit per week through the end of Week 4; one 15-20 minute SMM visit at Week 6 and at Week 8. And in Phase 2, one 30-60 minute initial visit; one 15-20 minute follow-up visit later in Week 1; one individual session (15-20 minutes) per week through Week 12. In addition, participants in Phase 1 will receive BUP/NX at between 8 to 32mg/day; tapering to zero between weeks three and four. Those referred to Phase 2 will receive up to 32 mg/day for three months tapering to zero during month four.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition at End of Phase 1
Time Frame: 12 weeks
In Phase 1, successful outcome was defined as completing week 12 with self-reported opioid use on no more than 4 days in a month, absence of 2 consecutive opioid-positive urine test results, no additional substance use disorder treatment (other than self-help), and no more than 1 missing urine sample during the 12 weeks.
12 weeks
The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition, Phase 2 End of Treatment
Time Frame: 12 weeks in Phase 2 period (i.e., 24 weeks into the study)
In phase 2, successful outcome was defined as abstaining from opioids during week 12 (the final week of buprenorphine-naloxone stabilization) and during at least 2 of the previous 3 weeks (weeks 9-11). This outcome measure required substantial improvement but not complete abstinence.
12 weeks in Phase 2 period (i.e., 24 weeks into the study)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition Phase 2, 8-week Posttreatment Follow-up
Time Frame: 24 weeks in Phase 2 period (i.e., 36 weeks into the study)
A planned secondary outcome, successful outcome at week 24, that is, 8 weeks after completion of buprenorphine-naloxone taper, was defined the same as at week 12 of Phase 2, that is abstinent from opioids during week 24 and at least 2 of the previous 3 weeks.
24 weeks in Phase 2 period (i.e., 36 weeks into the study)
The Number of Participants Attaining Successful Opioid Use Outcomes in Phase 1 by Chronic Pain Condition
Time Frame: 12 weeks
As a planned secondary analysis, we examined the impact of the two Phase 1 stratification variables on the primary end points. Patients were designated at baseline as having current chronic pain if they reported pain "other than everyday kinds of pain" excluding withdrawal-related pain, for at least 3 months.
12 weeks
The Number of Participants Attaining Successful Opioid Use Outcomes in Phase 2 by Chronic Pain Condition
Time Frame: 12 weeks
As a planned secondary analysis, we examined the impact of the two Phase 1 stratification variables on the primary end points. Patients were designated at baseline as having current chronic pain if they reported pain "other than everyday kinds of pain" excluding withdrawal-related pain, for at least 3 months.
12 weeks
The Number of Participants With and Without Any Lifetime Use of Heroin Attaining Successful Opioid Use Outcomes in Phase 1
Time Frame: 12 weeks
As a planned secondary analysis, we examined the impact of the two phase 1 stratification variables on the primary outcome.
12 weeks
The Number of Participants With and Without Any Lifetime Use of Heroin Attaining Successful Opioid Use Outcomes in Phase 2
Time Frame: 12 weeks
As a planned secondary analysis, we examined the impact of the two phase 1 stratification variables on the primary outcome.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mclean Hospital

Collaborators

University of California, Los Angeles

Investigators

  • Principal Investigator: Roger Weiss, M.D., McLean Hospital
  • Principal Investigator: Walter Ling, M.D., University of California, Las Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

April 18, 2006

First Submitted That Met QC Criteria

April 18, 2006

First Posted (Estimate)

April 20, 2006

Study Record Updates

Last Update Posted (Estimate)

February 6, 2013

Last Update Submitted That Met QC Criteria

February 1, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-CTN-0030

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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