Prescription Opioid Addiction Treatment Study (POATS)

• 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.
  
  

• 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.
  
  

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.