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Buprenorphine Maintenance vs. Detoxification in Prescription Opioid Dependence

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
David Fiellin, Yale University
ClinicalTrials.gov Identifier:
NCT00555425
First received: November 6, 2007
Last updated: January 23, 2017
Last verified: January 2017
Results First Received: January 25, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Opiate Dependence
Interventions: Behavioral: Behavioral: Buprenorphine/naloxone maintenance (Mtn)
Behavioral: Behavioral: Buprenorphine/naloxone detoxification (Dtx)

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
289 Patients underwent assessment for eligibility, 29 did not meet inclusion criteria, 132 lost contact or chose other treatment, and 15 did not complete induction

Reporting Groups
  Description
Taper Condition

Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.

Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup.

Maintenance Condition

Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.

Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study.


Participant Flow:   Overall Study
    Taper Condition   Maintenance Condition
STARTED   57   56 
COMPLETED   6   37 
NOT COMPLETED   51   19 
Missed Medication > 1 wk                34                15 
Missed 3 physician management visits                1                0 
Met criteria for protective transfer                16                3 
Became pregnant and transferred care                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
Taper Condition

Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.

Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup.

Maintenance Condition

Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.

Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study.

Total Total of all reporting groups

Baseline Measures
   Taper Condition   Maintenance Condition   Total 
Overall Participants Analyzed 
[Units: Participants]
 57   56   113 
Age 
[Units: Years]
Mean (Standard Deviation)
 30.3  (8.8)   30.5  (9.8)   30.4  (9.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      23  40.4%      25  44.6%      48  42.5% 
Male      34  59.6%      31  55.4%      65  57.5% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      4   7.0%      4   7.1%      8   7.1% 
Not Hispanic or Latino      53  93.0%      52  92.9%      105  92.9% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      1   1.8%      0   0.0%      1   0.9% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      1   1.8%      1   0.9% 
White      56  98.2%      52  92.9%      108  95.6% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      3   5.4%      3   2.7% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Illicit Opioid Use   [ Time Frame: 18 weeks ]

2.  Secondary:   Proportion of Patients Protectively Transferred   [ Time Frame: 18 weeks ]

3.  Secondary:   Retention in Treatment   [ Time Frame: 18 weeks ]

4.  Secondary:   Reduction in Cocaine Use   [ Time Frame: 18 weeks ]

5.  Secondary:   Changes in HIV Risk   [ Time Frame: Baseline and 18 weeks ]

6.  Secondary:   Patient Satisfaction   [ Time Frame: 18 weeks ]

7.  Secondary:   Health Status   [ Time Frame: 18 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. David Fiellin
Organization: Yale University
phone: 203-688-2471
e-mail: david.fiellin@yale.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: David Fiellin, Yale University
ClinicalTrials.gov Identifier: NCT00555425     History of Changes
Obsolete Identifiers: NCT00595400
Other Study ID Numbers: 1R01DA020576-01A1 ( US NIH Grant/Contract Award Number )
R01DA020576 ( US NIH Grant/Contract Award Number )
DPMC ( Other Identifier: NIDA )
Study First Received: November 6, 2007
Results First Received: January 25, 2016
Last Updated: January 23, 2017