Opioid-Related DisordersMATICCENCT01344122
Medication-Assisted Treatment Implementation in Community Correctional Environments (MATICCE)
A study testing KPI training only and KPI plus OLI in people with Opioid-Related Disorders and Alcohol-Related Disorders, run by Rhode Island Hospital.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Opioid-Related Disorders, Alcohol-Related Disorders
- What is being tested?
- KPI training only and KPI plus OLI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Oct 2010to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Probation/parole or community treatment agency staff.
About this study
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.
- Being tested
- KPI training only, KPI plus OLI
- Medical subject headings
- Opioid-Related Disorders, Alcohol-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KPI training onlyOther
See comparison arm description.
KPI plus OLIOther
See experimental arm description.
| Study group | Role | What they receive |
|---|---|---|
| KPI training only | Active comparator | Study sites randomized to this arm will receive a knowledge, perceptions and information (KPI) training for community correctional and treatment staff to address knowledge, perceptions, and information regarding local resources about MAT. Receives: Other: KPI training only |
| KPI plus OLI | Experimental | Study sites randomized to this arm will receive the KPI training plus a Organizational Linkage Intervention (OLI) that will: (a) establish a local Pharmacotherapy Exchange Council (PEC) among agencies important for the implementation of MAT in community corrections; (b) facilitate a strategic planning process within the PEC to increase the availability of MAT for opiate and/or alcohol dependent individuals who are on probation/parole; and (c) identify a community corrections coordinator in one of the local agencies to operationalize and implement the strategic plan. Receives: Other: KPI plus OLI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6-month follow-up
Secondary outcomes (2)
Interorganizational Relationships
Will be assessed at baseline, and post intervention (6-month follow-up).
Measured: 6-month follow-up
Referrals to Medication Assisted Treatment (MAT)
Estimated numbers of alcohol- and opiate-dependent offenders on Probation/Parole
Measured: 6-Month Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2011 (estimated)
- Study startOct 2010
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Principal investigator, Peter D. Friedmann, Rhode Island Hospital
- Investigators
- Peter D Friedmann, MD, MPH, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01344122
- Sponsor's protocol ID
- CJDATS2-001
- Other IDs
- U01DA016191
- Acronym
- MATICCE
- Status last verified
- Oct 2014
- First submitted
- 21 Apr 2011
- Last updated
- 30 Oct 2014
- Results posted
- No
Publications
Friedmann PD, Wilson D, Knudsen HK, Ducharme LJ, Welsh WN, Frisman L, Knight K, Lin HJ, James A, Albizu-Garcia CE, Pankow J, Hall EA, Urbine TF, Abdel-Salam S, Duvall JL, Vocci FJ. Effect of an organizational linkage intervention on staff perceptions of medication-assisted treatment and referral intentions in community corrections. J Subst Abuse Treat. 2015 Mar;50:50-8. doi: 10.1016/j.jsat.2014.10.001. Epub 2014 Oct 14.
PubMed 25456091
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication-Assisted Treatment Implementation in Community Correctional Environments (MATICCE)
- ClinicalTrials.gov ID
- NCT01344122
- Acronym / sponsor ID
- MATICCE / CJDATS2-001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- 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
- Study start
- Oct 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 28 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KPI training only | Active comparator | Other: KPI training onlyStudy sites randomized to this arm will receive a knowledge, perceptions and information (KPI) training for community correctional and treatment staff to address knowledge, perceptions, and information regarding local resources about MAT. |
| KPI plus OLI | Experimental | Other: KPI plus OLIStudy sites randomized to this arm will receive the KPI training plus a Organizational Linkage Intervention (OLI) that will: (a) establish a local Pharmacotherapy Exchange Council (PEC) among agencies important for the implementation of MAT in community corrections; (b) facilitate a strategic planning process within the PEC to increase the availability of MAT for opiate and/or alcohol dependent individuals who are on probation/parole; and (c) identify a community corrections coordinator in one of the local agencies to operationalize and implement the strategic plan. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KPI training onlySee comparison arm description. | Other | KPI training only |
| KPI plus OLISee experimental arm description. | Other | KPI plus OLI |
Primary outcome
Opinions About MAT
Time frame: 6-month follow-up
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.
2 secondary outcomes
Interorganizational Relationships
Time frame: 6-month follow-up
Referrals to Medication Assisted Treatment (MAT)
Time frame: 6-Month Follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2014.
- Derived from this study: PubMed 25456091Friedmann PD, Wilson D, Knudsen HK, Ducharme LJ, Welsh WN, Frisman L, Knight K, Lin HJ, James A, Albizu-Garcia CE, Pankow J, Hall EA, Urbine TF, Abdel-Salam S, Duvall JL, Vocci FJ. Effect of an organizational linkage intervention on staff perceptions of medication-assisted treatment and referral intentions in community corrections. J Subst Abuse Treat. 2015 Mar;50:50-8. doi: 10.1016/j.jsat.2014.10.001. Epub 2014 Oct 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter D Friedmann, MD, MPH principal investigator
Rhode Island Hospital
Questions about this trial
What is this clinical trial studying?
A study testing KPI training only and KPI plus OLI in people with Opioid-Related Disorders and Alcohol-Related Disorders, run by Rhode Island Hospital.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opinions About MAT (time frame: 6-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01344122, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2014.