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
Results First Received: May 8, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Opiate Dependence
Substance-related Disorders
Opioid-related Disorders
Interventions: Behavioral: Standard Medical Management (SMM) of Prescription Opiate Abuse
Behavioral: Enhanced Medical Management (EMM) of Prescription Opiate Abuse

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
653 treatment-seeking outpatients dependent on prescription opioids across 10 U.S. sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Buprenorphine/Nx With EMM All study participants received buprenorphine-naloxone. This treatment group (Buprenorphine/Naloxone with Enhanced Medical Management) consisted of Standard Medical Management office visits with study physicians certified to prescribe buprenorphine and opioid drug counseling from a trained substance abuse or mental health professional.
Buprenorphine/Nx With SMM All study participants received buprenorphine-naloxone medication. This treatment group (buprenorphine-naloxone with Standard Medical Management) consisted of office visits with study physicians certified to prescribe buprenorphine.

Participant Flow for 2 periods

Period 1:   Phase 1 (12 Weeks)
    Buprenorphine/Nx With EMM     Buprenorphine/Nx With SMM  
STARTED     329     324  
COMPLETED     19     24  
NOT COMPLETED     310     300  
Lost to Follow-up                 88                 75  
Investigator-initiated termination                 2                 0  
Eligible for Phase 2                 220                 225  

Period 2:   Phase 2 (24 Weeks)
    Buprenorphine/Nx With EMM     Buprenorphine/Nx With SMM  
STARTED     180     180  
COMPLETED     161     161  
NOT COMPLETED     19     19  
Lost to Follow-up prior to wk 13                 19                 18  
Discontinued intervention (jailed)                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Buprenorphine/Nx With EMM All study participants received buprenorphine-naloxone. This treatment group (Buprenorphine/Naloxone with Enhanced Medical Management) consisted of Standard Medical Management office visits with study physicians certified to prescribe buprenorphine and opioid drug counseling from a trained substance abuse or mental health professional.
Buprenorphine/Nx With SMM All study participants received buprenorphine-naloxone medication. This treatment group (buprenorphine-naloxone with Standard Medical Management) consisted of office visits with study physicians certified to prescribe buprenorphine.
Total Total of all reporting groups

Baseline Measures
    Buprenorphine/Nx With EMM     Buprenorphine/Nx With SMM     Total  
Number of Participants  
[units: participants]
  329     324     653  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     329     324     653  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  32.9  ± 10.1     33.5  ± 10.3     33.2  ± 10.2  
Gender  
[units: participants]
     
Female     125     136     261  
Male     204     188     392  
Region of Enrollment  
[units: participants]
     
United States     329     324     653  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition at End of Phase 1   [ Time Frame: 12 weeks ]

2.  Primary:   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) ]

3.  Secondary:   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) ]

4.  Secondary:   The Number of Participants Attaining Successful Opioid Use Outcomes in Phase 1 by Chronic Pain Condition   [ Time Frame: 12 weeks ]

5.  Secondary:   The Number of Participants Attaining Successful Opioid Use Outcomes in Phase 2 by Chronic Pain Condition   [ Time Frame: 12 weeks ]

6.  Secondary:   The Number of Participants With and Without Any Lifetime Use of Heroin Attaining Successful Opioid Use Outcomes in Phase 1   [ Time Frame: 12 weeks ]

7.  Secondary:   The Number of Participants With and Without Any Lifetime Use of Heroin Attaining Successful Opioid Use Outcomes in Phase 2   [ Time Frame: 12 weeks ]
  Hide Outcome Measure 7

Measure Type Secondary
Measure Title The Number of Participants With and Without Any Lifetime Use of Heroin Attaining Successful Opioid Use Outcomes in Phase 2
Measure Description As a planned secondary analysis, we examined the impact of the two phase 1 stratification variables on the primary outcome.
Time Frame 12 weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Success in Phase 2 Among Participants With Heroin Use No text entered.
Success in Phase 2 Among Participants Without Heroin Use No text entered.

Measured Values
    Success in Phase 2 Among Participants With Heroin Use     Success in Phase 2 Among Participants Without Heroin Use  
Number of Participants Analyzed  
[units: participants]
  100     260  
The Number of Participants With and Without Any Lifetime Use of Heroin Attaining Successful Opioid Use Outcomes in Phase 2  
[units: participants]
  37     140  

No statistical analysis provided for The Number of Participants With and Without Any Lifetime Use of Heroin Attaining Successful Opioid Use Outcomes in Phase 2




  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
A treatment providing infrequent or no medical management was not included. It is not known if less intensive medical management would affect outcomes. Length of the trial may have also affected results. Pain severity was only moderate on average.  


Results Point of Contact:  
Name/Title: Roger D. Weiss, M.D.
Organization: McLean Hospital/Harvard Medical School
phone: 617-855-2242
e-mail: rweiss@mclean.harvard.edu


Publications of Results:
Other Publications:


Responsible Party: Roger D. Weiss, Mclean Hospital
ClinicalTrials.gov Identifier: NCT00316277     History of Changes
Other Study ID Numbers: NIDA-CTN-0030
Study First Received: April 18, 2006
Results First Received: May 8, 2012
Last Updated: February 1, 2013
Health Authority: United States: Federal Government