NCT01442493

Brief Summary

The purpose of the study is to determine whether a change in the rules and staff roles in methadone treatment programs will result in greater lengths of stay in treatment and lower rates of heroin and cocaine use, crime and HIV-risk behavior as compared to methadone treatment as usual.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

2 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, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2011

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 28, 2011

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

September 18, 2017

Completed
Last Updated

December 29, 2017

Status Verified

December 1, 2017

Enrollment Period

3.6 years

First QC Date

September 7, 2011

Results QC Date

February 1, 2017

Last Update Submit

December 5, 2017

Conditions

Opiate Dependence

Keywords

Methadone TreatmentOpiate dependenceServices research

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Opiate Positive Urine Tests

    Number of participants with opiate positive urine tests

    12-months post-baseline

Secondary Outcomes (6)

  • Number of Participants With Cocaine Positive Urine Tests

    12-months post-baseline

  • Drug Use HIV Risk Behavior

    12-months post-baseline

  • Criminal Behavior

    12-months post-baseline

  • Global Score on the World Health Organization Quality of Life Measure

    12-months post-baseline

  • Number of Participants Meeting DSM-IV Opiate Dependence Criteria

    12-months post-baseline

  • +1 more secondary outcomes

Study Arms (2)

Patient-Centered Methadone Treatment

EXPERIMENTAL

Patient-Centered Methadone Treatment alters the rules and staff roles in methadone treatment as usual in an attempt to increase treatment retention and improve patient outcomes.

Other: Patient-Centered Methadone Treatment

Methadone Treatment as Usual

ACTIVE COMPARATOR

Methadone treatment provided as usual in the U.S.

Other: Methadone Treatment as usual

Interventions

Patient-Centered Methadone TreatmentOTHER

Unlike in treatment as usual, counseling will be encouraged but not required and counselors will be responsible for enforcing the clinic's rules. The rules will be enforced by the Clinical Director. Clinic rules will be modified such that involuntary discharge from treatment will be a rare event.

Patient-Centered Methadone Treatment
Methadone Treatment as usualOTHER

Counseling will be required and counselors will enforce the usual clinic rules. Involuntary discharge may occur for ongoing drug use or rule infractions as usually occurs in the clinic.

Methadone Treatment as Usual

Eligibility Criteria

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

You may qualify if:

  • opiate dependence
  • newly admitted to methadone treatment

You may not qualify if:

  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institutes for Behavior Resources REACH

Baltimore, Maryland, 21218, United States

Location

University of Maryland Drug Treatment Center

Baltimore, Maryland, 21223, United States

Location

Related Publications (1)

  • Mitchell SG, Monico LB, Lertch E, Kelly SM, Gryczynski J, Jaffe JH, O'Grady KE, Schwartz RP. Counseling Staff's Views of Patient-Centered Methadone Treatment: Changing Program Rules and Staff Roles. J Behav Health Serv Res. 2018 Jul;45(3):506-515. doi: 10.1007/s11414-018-9603-1.

    PMID: 29536342DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Robert Schwartz, M.D.
Organization
Friends Research Institute
rschwartz@friendsresearch.org
410-837-3977

Study Officials

  • Robert P Schwartz, M.D.

    Friends Research Institute, Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2011

First Posted

September 28, 2011

Study Start

September 1, 2011

Primary Completion

April 1, 2015

Study Completion

August 1, 2015

Last Updated

December 29, 2017

Results First Posted

September 18, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

US(2)