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

April 18, 2006
February 1, 2013
May 2006
July 2009   (final data collection date for primary outcome measure)
  • 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.
Opiate abstinence
Complete list of historical versions of study NCT00316277 on ClinicalTrials.gov Archive Site
  • 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.
  • Withdrawal symptoms
  • Craving symptoms
  • Reduction in drug use
  • Effect of pain
  • Safety
Not Provided
Not Provided
 
Prescription Opioid Addiction Treatment Study (POATS)
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Opiate Dependence
  • Substance-related Disorders
  • Opioid-related Disorders
  • 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.
  • 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.
  • Experimental: Buprenorphine/Nx with EMM
    Intervention: Behavioral: Enhanced Medical Management (EMM) of Prescription Opiate Abuse
  • Active Comparator: Buprenorphine/Nx with SMM
    Intervention: Behavioral: Standard Medical Management (SMM) of Prescription Opiate Abuse

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
653
January 2013
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00316277
NIDA-CTN-0030
Yes
Roger D. Weiss, Mclean Hospital
Mclean Hospital
University of California, Los Angeles
Principal Investigator: Roger Weiss, M.D. Mclean Hospital
Principal Investigator: Walter Ling, M.D. University of California, Las Angeles
Mclean Hospital
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP