Prescription Opioid Addiction Treatment Study (POATS)
- Conditions
- Opiate DependenceSubstance-related DisordersOpioid-related Disorders
- Interventions
- Behavioral: Enhanced Medical Management (EMM) of Prescription Opiate AbuseBehavioral: Standard Medical Management (SMM) of Prescription Opiate Abuse
- Registration Number
- NCT00316277
- Lead Sponsor
- Mclean Hospital
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 653
- 18 years old or older
- Physically dependent on opioids
- Meet DSM-IV criteria for opioid dependence
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Buprenorphine/Nx with EMM Enhanced Medical Management (EMM) of Prescription Opiate Abuse - Buprenorphine/Nx with SMM Standard Medical Management (SMM) of Prescription Opiate Abuse -
- Primary Outcome Measures
Name Time Method The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition at End of Phase 1 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.
The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition, Phase 2 End of Treatment 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.
- Secondary Outcome Measures
Name Time Method The Number of Participants Attaining Successful Opioid Use Outcomes in Phase 1 by Chronic Pain Condition 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.
The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition Phase 2, 8-week Posttreatment Follow-up 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.
The Number of Participants Attaining Successful Opioid Use Outcomes in Phase 2 by Chronic Pain Condition 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.
The Number of Participants With and Without Any Lifetime Use of Heroin Attaining Successful Opioid Use Outcomes in Phase 1 12 weeks 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 12 weeks As a planned secondary analysis, we examined the impact of the two phase 1 stratification variables on the primary outcome.
Trial Locations
- Locations (12)
East Indiana Treatment Center
🇺🇸Lawrenceburg, Indiana, United States
North Shore - Long Island Jewish Health Systems
🇺🇸Glen Oaks, New York, United States
McLean Hospital, Alcohol and Drug Abuse Treatment Program
🇺🇸Belmont, Massachusetts, United States
Bellevue Hospital Center
🇺🇸New York, New York, United States
St. Luke's Roosevelt Hospital Center
🇺🇸New York, New York, United States
Behavioral Health Services of Pickens County
🇺🇸Pickens, South Carolina, United States
Providence Behavioral Health Service
🇺🇸Everett, Washington, United States
ADAPT, Inc.
🇺🇸Roseburg, Oregon, United States
Integrated Substance Abuse Programs
🇺🇸Los Angeles, California, United States
San Francisco General Hospital
🇺🇸San Francisco, California, United States
Homeward Bound, Inc.
🇺🇸Dallas, Texas, United States
Chestnut Ridge Hospital
🇺🇸Morgantown, West Virginia, United States