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Starting Treatment With Agonist Replacement Therapies (START)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00315341
First Posted: April 18, 2006
Last Update Posted: January 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Walter Ling, University of California, Los Angeles
Results First Submitted: May 17, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Opiate-related Disorders
Interventions: Drug: Buprenorphine/naloxone
Drug: Methadone

  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
Methadone clinics in California, Oregon, Washington, Pennsylvania, New York, and Connecticut

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 Participants received medication for 24 weeks in the active phase of the study. The mean dose of buprenorphine was 22.3 mg. Blood samples for measurement of liver function were taken at baseline and at Weeks 1, 2, 4 8, 12, 16, 20, and 24 with follow-up at Week 32.
Methadone The mean dose of methadone was 93.2 mg.

Participant Flow:   Overall Study
    Buprenorphine/Nx   Methadone
STARTED   740   529 
COMPLETED   340   391 
NOT COMPLETED   400   138 



  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 No text entered.
Methadone No text entered.
Total Total of all reporting groups

Baseline Measures
   Buprenorphine/Nx   Methadone   Total 
Overall Participants Analyzed 
[Units: Participants]
 740   529   1269 
Age 
[Units: Years]
Mean (Standard Deviation)
 37.5  (11.2)   37.3  (10.9)   37.4  (11.1) 
Gender 
[Units: Participants]
Count of Participants
     
Female      238  32.2%      170  32.1%      408  32.2% 
Male      502  67.8%      359  67.9%      861  67.8% 


  Outcome Measures

1.  Primary:   Hepatic Safety   [ Time Frame: 24 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: Walter Ling, M.D.
Organization: University of California, Los Angeles
phone: (310) 933-8111
e-mail: lwalter@ucla.edu


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

Responsible Party: Walter Ling, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00315341     History of Changes
Other Study ID Numbers: NIDA-CTN-0027
U10DA013045 ( U.S. NIH Grant/Contract )
First Submitted: April 16, 2006
First Posted: April 18, 2006
Results First Submitted: May 17, 2013
Results First Posted: January 6, 2017
Last Update Posted: January 6, 2017