NCT01592461

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
877

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2010

Longer than P75 for all trials

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 3, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 7, 2012

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 8, 2016

Status Verified

August 1, 2016

Enrollment Period

5.9 years

First QC Date

May 3, 2012

Last Update Submit

August 4, 2016

Conditions

Opioid Dependence

Keywords

Substance abuse treatment outcomesOpioid dependenceSuboxoneMethadone

Outcome Measures

Primary Outcomes (1)

  • Opioid use as determined by the Timeline Follow Back measure

    Opiate use over approximately ten years time period

    from 2006-2009 to 2011-2016

Secondary Outcomes (1)

  • mortality

    from 2006-2009 to 2011-2016

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Matrix Institute on Addictions

Los Angeles, California, 90016, United States

Location

Bi-Valley Medical Clinic, Inc.

Sacramento, California, 95838, United States

Location

BAART Programs

San Francisco, California, 94102, United States

Location

Hartford Dispensary

Hartford, Connecticut, 06120, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

CODA, Inc.

Portland, Oregon, 97214, United States

Location

NET Steps

Philadelphia, Pennsylvania, 19137, United States

Location

Evergreen Treatment Services

Seattle, Washington, 98134, United States

Location

Related Publications (2)

  • Hser YI, Zhu Y, Fei Z, Mooney LJ, Evans EA, Kelleghan A, Matthews A, Yoo C, Saxon AJ. Long-term follow-up assessment of opioid use outcomes among individuals with comorbid mental disorders and opioid use disorder treated with buprenorphine or methadone in a randomized clinical trial. Addiction. 2022 Jan;117(1):151-161. doi: 10.1111/add.15594. Epub 2021 Jun 22.

    PMID: 34105213DERIVED

  • Evans EA, Yoo C, Huang D, Saxon AJ, Hser YI. Effects of access barriers and medication acceptability on buprenorphine-naloxone treatment utilization over 2 years: Results from a multisite randomized trial of adults with opioid use disorder. J Subst Abuse Treat. 2019 Nov;106:19-28. doi: 10.1016/j.jsat.2019.08.002. Epub 2019 Aug 7.

    PMID: 31540607DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Yih-Ing Hser, Ph.D.

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 3, 2012

First Posted

May 7, 2012

Study Start

September 1, 2010

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

August 8, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share

Deidentified data will be shared via NIDA Clinical Trials Network Website

Locations

US(8)