Phase 3
N=653
Prescription Opioid Addiction Treatment Study (POATS)
Opiate Dependence · Substance-related Disorders · Opioid-related Disorders
Bottom Line
View on ClinicalTrials.gov: NCT00316277 ↗Enrolled (actual)
653
Serious AEs
1.7%
Results posted
Jul 2012
Primary outcome: Primary: The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition at End of Phase 1 — 19; 24 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Standard Medical Management (SMM) of Prescription Opiate Abuse (Behavioral); Enhanced Medical Management (EMM) of Prescription Opiate Abuse (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mclean Hospital
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition at End of Phase 1 |
19; 24 | — |
| PRIMARY The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition, Phase 2 End of Treatment |
93; 84 | — |
| SECONDARY The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition Phase 2, 8-week Posttreatment Follow-up |
18; 13 | — |
| SECONDARY The Number of Participants Attaining Successful Opioid Use Outcomes in Phase 1 by Chronic Pain Condition |
30; 13 | — |
| SECONDARY The Number of Participants Attaining Successful Opioid Use Outcomes in Phase 2 by Chronic Pain Condition |
79; 98 | — |
| SECONDARY The Number of Participants With and Without Any Lifetime Use of Heroin Attaining Successful Opioid Use Outcomes in Phase 1 |
9; 34 | — |
| SECONDARY The Number of Participants With and Without Any Lifetime Use of Heroin Attaining Successful Opioid Use Outcomes in Phase 2 |
37; 140 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00316277). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.