Prescription Opioid Addiction Treatment Study (POATS)

This study has been completed.
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
Roger D. Weiss, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT00316277
First received: April 18, 2006
Last updated: February 1, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Opiate Dependence
Substance-related Disorders
Opioid-related Disorders
Behavioral: Standard Medical Management (SMM) of Prescription Opiate Abuse
Behavioral: Enhanced Medical Management (EMM) of Prescription Opiate Abuse
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Two-Phase Randomized Controlled Clinical Trial of Buprenorphine/Naloxone Treatment Plus Standard Medical Management or Enhanced Medical Management for Opioid Analgesic Dependence

Resource links provided by NLM:


Further study details as provided by Mclean Hospital:

Primary Outcome Measures:
  • The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition at End of Phase 1 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.

  • The Number of Participants Attaining Successful Opioid Use Outcomes in Phase 1 by Chronic Pain Condition [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.

  • The Number of Participants Attaining Successful Opioid Use Outcomes in Phase 2 by Chronic Pain Condition [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.

  • The Number of Participants With and Without Any Lifetime Use of Heroin Attaining Successful Opioid Use Outcomes in Phase 1 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    As a planned secondary analysis, we examined the impact of the two phase 1 stratification variables on the primary outcome.

  • The Number of Participants With and Without Any Lifetime Use of Heroin Attaining Successful Opioid Use Outcomes in Phase 2 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    As a planned secondary analysis, we examined the impact of the two phase 1 stratification variables on the primary outcome.


Enrollment: 653
Study Start Date: May 2006
Study Completion Date: January 2013
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00316277

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

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Roger D. Weiss, Chief Divsion of Alcohol and Drug Abuse; Professor of Psychiatry, Mclean Hospital
ClinicalTrials.gov Identifier: NCT00316277     History of Changes
Other Study ID Numbers: NIDA-CTN-0030
Study First Received: April 18, 2006
Results First Received: May 8, 2012
Last Updated: February 1, 2013
Health Authority: United States: Federal Government

Keywords provided by Mclean Hospital:
Opiate Analgesic Dependence

Additional relevant MeSH terms:
Disease
Substance-Related Disorders
Opioid-Related Disorders
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotic Antagonists

ClinicalTrials.gov processed this record on September 18, 2014