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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01344122
Other study ID # CJDATS2-001
Secondary ID U01DA016191
Status Completed
Phase N/A
First received April 21, 2011
Last updated October 28, 2014
Start date October 2010
Est. completion date September 2013

Study information

Verified date October 2014
Source Rhode Island Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The goal of this study is to see whether or not a strategic planning process is able to introduce and sustain improvements in the working relationship between probation/parole departments and community-based addiction treatment agencies that provide medication assisted therapy (MAT) for individuals with opioid or alcohol dependence. In addition, this study seeks to improve probation/parole agency personnel's knowledge and perceptions about MAT, and increase the number of appropriate referrals to community treatment agencies that provide MAT. There are three phases to this study. Phase 1 includes a pilot study to determine the quality and availability of client level records and the collection of baseline data (the pilot study protocol was previously submitted to TMH IRB). Phase 2 will consist of a Knowledge, Perceptions and Information (KPI) intervention during which probation/parole agencies will undergo training to increase knowledge about the effectiveness of MAT, and complete a post training assessment to evaluate the effectiveness of the KPI intervention. During Phase 3, probation/parole agencies will be randomly assigned to a 12-month Organizational Linkage Intervention (OLI) condition or to control (no further intervention). Agencies assigned to the OLI will establish a Pharmacotherapy Exchange Council (PEC) that consists of staff from both the probation/parole and community treatment agencies. The PEC will undergo a strategic planning process to increase the availability of MAT for opiate and/or alcohol dependent individuals who are on probation/parole.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Probation/parole or community treatment agency staff.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label


Intervention

Other:
KPI training only
See comparison arm description.
KPI plus OLI
See experimental arm description.

Locations

Country Name City State
n/a

Sponsors (12)

Lead Sponsor Collaborator
Rhode Island Hospital Arizona State University, Friends Research Institute, Inc., National Development and Research Institutes, Inc., National Institute on Drug Abuse (NIDA), Temple University, Texas Christian University, University of California, Los Angeles, University of Connecticut, University of Delaware, University of Kentucky, University of Puerto Rico

Outcome

Type Measure Description Time frame Safety issue
Primary Opinions About MAT Measures knowledge, perceptions, and intentions regarding the use of pharmacotherapy for the treatment of opioid and alcohol dependence. Will be assessed at baseline, post-training, post intervention, and 6-month follow-up. 6-month follow-up No
Secondary Interorganizational Relationships Will be assessed at baseline, and post intervention (6-month follow-up). 6-month follow-up No
Secondary Referrals to Medication Assisted Treatment (MAT) Estimated numbers of alcohol- and opiate-dependent offenders on Probation/Parole 6-Month Follow-up No
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