Opioid-use DisorderNCT04188977
Facilitating the Implementation of Interim Methadone to Increase Treatment Access
A study testing Usual Practice and Implementation Facilitation in people with Opioid-use Disorder, run by Friends Research Institute, Inc. at 1 site in United States.
Trial summary
The primary aim of this study is to evaluate the effectiveness of Implementation Facilitation (IF) in promoting increased accessibility to methadone treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- Usual Practice and Implementation Facilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 30 Apr 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- OTP staff
- State health department staff responsible for OTP oversight
- requesting admission to OTP
Who cannot join
- Unwilling to be interviewed
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Robert Philip Schwartz, M.D.
Baltimore, Maryland, 21201
About this study
Official title: Facilitating the Implementation of Interim Methadone to Increase Treatment Access: A Multi-Site Implementation Trial
The primary aim of this study is to evaluate the effectiveness of Implementation Facilitation (IF) in promoting increased accessibility to methadone treatment.
Read the detailed description
This is a Type 3 implementation-effectiveness type study using a modified stepped wedge design. The study's purpose is to examine the effectiveness of Implementation Facilitation (IF) to prompt participating Opioid Treatment Programs (OTPs) to utilize interim methadone treatment and other approaches to reduce OTP admission delays. Interim methadone treamtent is an evidence-based practice permitted under federal OTP regulations to provide methadone treatment without routine counseling for individuals requesting methadone treatment who otherwise would not be able to be admitted to such treatment within 14 days of request. The study will be conducted at six OTPs in the US that are unable to admit individuals within 14 days of their request for methadone treatment. The OTPs will participate in a baseline Pre-Implementation Phase, an Implementation Phase, followed by a Sustainability Phase. OTPs will be randomly assigned in groups of two to the order in which they will initiate the Implementation Phase. IF will be delivered at the level of the OTP staff and their state health department official responsible for OTP oversight. OTP staff and state health department officials will be interviewed regarding facilitators and barriers to implementing interim methadone and other approaches to reduce admission delays. De-identified data will be gathered from the OTPs on the effectiveness of IF in prompting the implementation of interim methadone and reducing admission delays.
- Conditions
- Opioid-use Disorder
- Being tested
- Usual Practice, Implementation Facilitation
- Keywords
- Implementation Facilitation, Interim methadone treatment, Opioid Treatment Program
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual PracticeOther
OTP Directors are able to ask their state health officials permission to use interim methadone treatment. The state officials are in turn able to ask officials from the Center of Substance Abuse Treatment for permission to provide interim methadone treatment.
Implementation FacilitationOther
Implementation Facilitation (IF) will consist of educational outreach to OTP staff, identification of local champions, training, performance feedback, and learning collaborative for OTP staff and state health department officials.
| Study group | Role | What they receive |
|---|---|---|
| Usual Practice | Other | OTPs are able to request from state and federal health department officials to utilize interim methadone treatment to address admission delays in their OTP. Receives: Other: Usual Practice |
| Implementation Facilitation | Experimental | Implementation Facilitation (IF) will consist of educational outreach to OTP staff, identification of local champions, training, performance feedback, and learning collaborative for OTP staff and state health department officials. Receives: Other: Implementation Facilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accessibility
Accessibility will be assessed from de-identified OTP records as the proportion of individuals requesting methadone treatment who receive at least one dose of methadone through either interim methadone (IM) or standard methadone within 14 days, divided by the number of individuals requesting methadone treatment.
Measured: Nine months
Secondary outcomes (5)
Uptake
Uptake will be assessed from de-identified OTP records as the proportion of individuals unable to gain admission within 14 days who receive at least one interim methadone dose divided by the number of individuals who were unable to be admitted within 14 days.
Measured: Nine months
Efficiency
Efficiency will be assessed from de-identified OTP records as the number of days from the request for OTP admission prior to receiving a first methadone dose.
Measured: Nine months
Fidelity
Fidelity will be assessed from de-identified OTP records as the proportion of interim methadone patients transferred to standard methadone treatment within the permitted time limit from starting interim methadone treatment.
Measured: Six months
Uptake during the Sustainability Phase
Sustainability will be assessed from de-identified OTP records as the proportion of interim methadone patients admitted within 14 days of request during the Sustainability Phase
Measured: Six months
Effectiveness: percentage of opioid positive tests
Effectiveness will be assessed from de-identified OTP records as the percentage of opioid-positive urine tests of interim methadone patients at the time of transfer to standard methadone treatment
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start1 Nov 2019
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opioid-use DisorderStudies 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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Type 3 implementation-effectiveness type study using a modified stepped wedge design
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Friends Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Robert P Schwartz, M.D., Principal investigator, Friends Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04188977
- Sponsor's protocol ID
- U01DA046910
- Other IDs
- U01DA046910
- Status last verified
- Jul 2022
- First submitted
- 12 Nov 2019
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gryczynski J, Mitchell SG, Whitter M, Fuller D, Mitchell MM, Edelman EJ, Schwartz RP. A trial of implementation facilitation to increase timely admission to methadone treatment. J Subst Use Addict Treat. 2024 Jul;162:209375. doi: 10.1016/j.josat.2024.209375. Epub 2024 Apr 19.
PubMed 38642889Mitchell SG, Jester J, Gryczynski J, Whitter M, Fuller D, Halsted C, Schwartz RP. Impact of COVID-19-related methadone regulatory flexibilities: views of state opioid treatment authorities and program staff. Addict Sci Clin Pract. 2023 Oct 17;18(1):61. doi: 10.1186/s13722-023-00417-7.
PubMed 37848970
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating the Implementation of Interim Methadone to Increase Treatment Access: A Multi-Site Implementation Trial
- ClinicalTrials.gov ID
- NCT04188977
- Acronym / sponsor ID
- U01DA046910
- Conditions
- Opioid-use Disorder
- Keywords
- Implementation Facilitation, Interim methadone treatment, Opioid Treatment Program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Friends Research Institute, Inc.University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 6 Dec 2019 (actual)
- 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 primary aim of this study is to evaluate the effectiveness of Implementation Facilitation (IF) in promoting increased accessibility to methadone treatment.
Detailed description
This is a Type 3 implementation-effectiveness type study using a modified stepped wedge design. The study's purpose is to examine the effectiveness of Implementation Facilitation (IF) to prompt participating Opioid Treatment Programs (OTPs) to utilize interim methadone treatment and other approaches to reduce OTP admission delays. Interim methadone treamtent is an evidence-based practice permitted under federal OTP regulations to provide methadone treatment without routine counseling for individuals requesting methadone treatment who otherwise would not be able to be admitted to such treatment within 14 days of request. The study will be conducted at six OTPs in the US that are unable to admit individuals within 14 days of their request for methadone treatment. The OTPs will participate in a baseline Pre-Implementation Phase, an Implementation Phase, followed by a Sustainability Phase. OTPs will be randomly assigned in groups of two to the order in which they will initiate the Implementation Phase. IF will be delivered at the level of the OTP staff and their state health department official responsible for OTP oversight. OTP staff and state health department officials will be interviewed regarding facilitators and barriers to implementing interim methadone and other approaches to reduce admission delays. De-identified data will be gathered from the OTPs on the effectiveness of IF in prompting the implementation of interim methadone and reducing admission delays.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Type 3 implementation-effectiveness type study using a modified stepped wedge design
| Arm | Type | Receives |
|---|---|---|
| Usual Practice | Other | Other: Usual PracticeOTPs are able to request from state and federal health department officials to utilize interim methadone treatment to address admission delays in their OTP. |
| Implementation Facilitation | Experimental | Other: Implementation FacilitationImplementation Facilitation (IF) will consist of educational outreach to OTP staff, identification of local champions, training, performance feedback, and learning collaborative for OTP staff and state health department officials. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- OTP staff
- State health department staff responsible for OTP oversight
- requesting admission to OTP
Key exclusion criteria (2 listed)
- Unwilling to be interviewed
- None
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 |
|---|---|---|
| Usual PracticeOTP Directors are able to ask their state health officials permission to use interim methadone treatment. The state officials are in turn able to ask officials from the Center of Substance Abuse Treatment for permission to provide interim methadone treatment. | Other | Usual Practice |
| Implementation FacilitationImplementation Facilitation (IF) will consist of educational outreach to OTP staff, identification of local champions, training, performance feedback, and learning collaborative for OTP staff and state health department officials. | Other | Implementation Facilitation |
Primary outcome
Accessibility
Time frame: Nine months
Accessibility will be assessed from de-identified OTP records as the proportion of individuals requesting methadone treatment who receive at least one dose of methadone through either interim methadone (IM) or standard methadone within 14 days, divided by the number of individuals requesting methadone treatment.
5 secondary outcomes
Uptake
Time frame: Nine months
Efficiency
Time frame: Nine months
Fidelity
Time frame: Six months
Uptake during the Sustainability Phase
Time frame: Six months
Effectiveness: percentage of opioid positive tests
Time frame: Six months
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 29 Jul 2022.
- Derived from this study: PubMed 38642889Gryczynski J, Mitchell SG, Whitter M, Fuller D, Mitchell MM, Edelman EJ, Schwartz RP. A trial of implementation facilitation to increase timely admission to methadone treatment. J Subst Use Addict Treat. 2024 Jul;162:209375. doi: 10.1016/j.josat.2024.209375. Epub 2024 Apr 19.
- Derived from this study: PubMed 37848970Mitchell SG, Jester J, Gryczynski J, Whitter M, Fuller D, Halsted C, Schwartz RP. Impact of COVID-19-related methadone regulatory flexibilities: views of state opioid treatment authorities and program staff. Addict Sci Clin Pract. 2023 Oct 17;18(1):61. doi: 10.1186/s13722-023-00417-7.
- Individual participant dataSharing planned: No
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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.
Robert P Schwartz, M.D. principal investigator
Friends Research Institute, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Usual Practice and Implementation Facilitation in people with Opioid-use Disorder, run by Friends Research Institute, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Accessibility (time frame: Nine months). 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 NCT04188977, which also lists 2 linked publications.
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 29 Jul 2022.