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Trial record 2 of 2 for:    Starting Treatment with Agonist Replacement Therapy

Starting Treatment With Agonist Replacement Therapies Follow-up Study

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. Identifier: NCT01592461
Recruitment Status : Completed
First Posted : May 7, 2012
Last Update Posted : August 8, 2016
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Yih-Ing Hser, University of California, Los Angeles

Brief Summary:

The purpose of the study is to conduct a follow-up of substance abuse patients (n=1,269) about 2 to 5 years since they were originally recruited from 8 substance abuse treatment clinics (located in 5 states) to participate in a prior clinical trial study called "START" (Starting Treatment with Agonist Replacement Therapies). The START Follow-up Study will be conducted over 5 years and will involve three follow-up interviews with START participants.

The specific aims of the START Follow-up Study are as follows.

  1. To determine longer-term outcomes of Suboxone versus methadone treatment received in the START
  2. To investigate patient and treatment factors associated with post-START treatment access, utilization, and outcomes among Suboxone and methadone patients
  3. To explore other correlates of the long-term outcomes among START patients.

Condition or disease
Opioid Dependence

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Study Type : Observational
Actual Enrollment : 877 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: START Follow-up Study (NIDA CTN Protocol 0050)
Study Start Date : September 2010
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Opioid use as determined by the Timeline Follow Back measure [ Time Frame: from 2006-2009 to 2011-2016 ]
    Opiate use over approximately ten years time period

Secondary Outcome Measures :
  1. mortality [ Time Frame: from 2006-2009 to 2011-2016 ]
    Rate of mortality over approximately ten years time period

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will include the 1,269 study participants from the original START Study (CTN-0027) that was conducted from 2006 to 2010 at eight community treatment programs (CTPs).

Inclusion Criteria:

  • To be eligible to participate in the study, individuals must have participated in CTN-0027 START.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01592461

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United States, California
Matrix Institute on Addictions
Los Angeles, California, United States, 90016
Bi-Valley Medical Clinic, Inc.
Sacramento, California, United States, 95838
BAART Programs
San Francisco, California, United States, 94102
United States, Connecticut
Hartford Dispensary
Hartford, Connecticut, United States, 06120
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
United States, Oregon
CODA, Inc.
Portland, Oregon, United States, 97214
United States, Pennsylvania
NET Steps
Philadelphia, Pennsylvania, United States, 19137
United States, Washington
Evergreen Treatment Services
Seattle, Washington, United States, 98134
Sponsors and Collaborators
University of California, Los Angeles
National Institute on Drug Abuse (NIDA)
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Principal Investigator: Yih-Ing Hser, Ph.D. University of California, Los Angeles
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Yih-Ing Hser, Professor, University of California, Los Angeles Identifier: NCT01592461    
Other Study ID Numbers: CTN-0050
U10DA013045 ( U.S. NIH Grant/Contract )
First Posted: May 7, 2012    Key Record Dates
Last Update Posted: August 8, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified data will be shared via NIDA Clinical Trials Network Website
Keywords provided by Yih-Ing Hser, University of California, Los Angeles:
Substance abuse treatment outcomes
Opioid dependence
Additional relevant MeSH terms:
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Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders