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Prescription Opioid Addiction Treatment Study (POATS)

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ClinicalTrials.gov Identifier: NCT00316277
Recruitment Status : Completed
First Posted : April 20, 2006
Results First Posted : July 27, 2012
Last Update Posted : February 6, 2013
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
Roger D. Weiss, Mclean Hospital

Tracking Information
First Submitted Date  ICMJE April 18, 2006
First Posted Date  ICMJE April 20, 2006
Results First Submitted Date  ICMJE May 8, 2012
Results First Posted Date  ICMJE July 27, 2012
Last Update Posted Date February 6, 2013
Study Start Date  ICMJE May 2006
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2012)
  • The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition at End of Phase 1 [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 18, 2006)
Opiate abstinence
Change History Complete list of historical versions of study NCT00316277 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2012)
  • 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) ]
    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 ]
    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 ]
    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 ]
    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 ]
    As a planned secondary analysis, we examined the impact of the two phase 1 stratification variables on the primary outcome.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2006)
  • Withdrawal symptoms
  • Craving symptoms
  • Reduction in drug use
  • Effect of pain
  • Safety
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prescription Opioid Addiction Treatment Study (POATS)
Official Title  ICMJE A Two-Phase Randomized Controlled Clinical Trial of Buprenorphine/Naloxone Treatment Plus Standard Medical Management or Enhanced Medical Management for Opioid Analgesic Dependence
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Opiate Dependence
  • Substance-related Disorders
  • Opioid-related Disorders
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 29, 2009)
653
Original Enrollment  ICMJE
 (submitted: April 18, 2006)
648
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00316277
Other Study ID Numbers  ICMJE NIDA-CTN-0030
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Roger D. Weiss, Mclean Hospital
Study Sponsor  ICMJE Mclean Hospital
Collaborators  ICMJE University of California, Los Angeles
Investigators  ICMJE
Principal Investigator: Roger Weiss, M.D. Mclean Hospital
Principal Investigator: Walter Ling, M.D. University of California, Las Angeles
PRS Account Mclean Hospital
Verification Date February 2013

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