Starting Treatment With Agonist Replacement Therapies Follow-up Study

August 4, 2016 updated by: Yih-Ing Hser, University of California, Los Angeles

START Follow-up Study (NIDA CTN Protocol 0050)

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.

Study Overview

Status

Completed

Conditions

Detailed Description

The primary outcome is the trajectory of opioid use since START entry, operationalized as number of days using opioids per month over the follow-up period since START enrollment. Other long-term outcomes of interest will include alcohol and other drug use, mental and physical health, quality of life, criminal justice status, HIV/HCV risk behaviors, and mortality. Treatment access and utilization factors of interest will include: predisposing personal factors, treatment experiences, and perceptions and attitudes toward treatment. Other correlates of interest will include cognitive functioning, mental health functioning, and social support.

2.2 Hypotheses There will be no differences in long-term outcomes of participants randomized to Suboxone treatment versus methadone treatment. To assess this outcome, trajectories of opioid use (operationalized as number of days using opioids per month over the follow-up period since START enrollment) will be analyzed. Other secondary long-term outcomes of interest will also be analyzed and will include alcohol and other drug use, mental and physical health, quality of life, criminal justice status, HIV/HCV risk behaviors, and mortality. Participants with greater access and utilization of treatment, fewer predisposing personal factors, greater social support, and more positive perceptions and attitudes toward treatment, will be more likely to be a member of the low or decreasing drug use trajectories.

2.3 Study Design This longitudinal, observational study will involve contacting the study participants from the original START study for future assessments. The study is expected to be completed in five years.

The follow-up study will consist of three interviews of the START study participants, beginning approximately 2 to 5 years after initial enrollment in the START study and will assess these participants over a 5-year period to provide long-term outcome data 7 to 10 years after START enrollment. This study information will be supplemented by (electronic) medical and other administrative records, as available. An intent-to-treat design will be adopted to include all 1,269 study participants enrolled in START.

Figure 1 presents a summary of the timeline for the conduct of project activities. There will be three participant interviews over the five years of the project. After receiving IRB approval for the conduct of the study, the START community treatment provider (CTP) or Node staff will contact their START participants, obtain participant consent to take part in the follow-up study, and conduct the initial assessment. This assessment will take place in the clinic if possible and by phone if the participant is not able to come in person.

By agreeing to take part in this study the participant will agree to:

  1. Updating their locator information initially and throughout the duration of the study;
  2. Sharing of clinic and survey data with the lead research team (UCLA);
  3. Completing various assessments and providing urine and oral fluid/blood specimens for lab assessments;
  4. Providing access to administrative records (e.g., medical records, criminal justice records);
  5. Being contacted by the study staff for 2 more interviews in person or by phone (consented prior to each interview).

Local CTP or Node staff will conduct the Visit 1 interview in Years 1-2 of the START follow-up study. Enrollment for the Visit 1 interview will remain open for the life of the study to allow sites that are able to continue to seek participants for Visit 1 beyond Year 2 of the study to do so. The Lead Node staff will conduct the Visit 2 interview by telephone approximately 12 months after the completion of Visit 1. The Lead Node and/or CTP staff will conduct another participant interview approximately 12-18 months after Visit 2 is completed. If a study participant is found late in the study progress for Visit 1, the following visits, 2 and 3 will occur sooner than originally planned, but as far apart as possible. All assessments are completed by the end of Year 5 of the START follow-up study.

Study Type

Observational

Enrollment (Actual)

877

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90016
        • Matrix Institute on Addictions
      • Sacramento, California, United States, 95838
        • Bi-Valley Medical Clinic, Inc.
      • San Francisco, California, United States, 94102
        • BAART Programs
    • Connecticut
      • Hartford, Connecticut, United States, 06120
        • Hartford Dispensary
      • New Haven, Connecticut, United States, 06510
        • Yale University School Of Medicine
    • Oregon
      • Portland, Oregon, United States, 97214
        • CODA, Inc.
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19137
        • NET Steps
    • Washington
      • Seattle, Washington, United States, 98134
        • Evergreen Treatment Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from 2006-2009 to 2011-2016

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality
Time Frame: from 2006-2009 to 2011-2016
Rate of mortality over approximately ten years time period
from 2006-2009 to 2011-2016

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Yih-Ing Hser, Ph.D., University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

May 3, 2012

First Submitted That Met QC Criteria

May 4, 2012

First Posted (Estimate)

May 7, 2012

Study Record Updates

Last Update Posted (Estimate)

August 8, 2016

Last Update Submitted That Met QC Criteria

August 4, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTN-0050
  • U10DA013045 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified data will be shared via NIDA Clinical Trials Network Website

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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