Opioid-use DisorderNCT03398265
Treatment Navigation for Opioid Use Disorder
A study testing Treatment Navigation (Intervention) in people with Opioid-use Disorder, run by University of Washington at 5 sites in United States.
Trial summary
The investigators will conduct a pilot randomized controlled trial (RCT) study of 100 people with a history of opioid use disorder releasing to WA Department of Corrections (DOC) community corrections supervision in King County. Half of the subjects will receive treatment as usual (e.g. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- Treatment Navigation (Intervention)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 5 sitesUnited States
- Study dates
- 20 Mar 2017to 13 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets Diagnostic and Statistical Manual (DSM-5) criteria for opioid use disorder (at least 2 criteria) or were receiving treatment for opioid use disorder in the 12 months prior to incarceration.
- Released to community corrections, not currently incarcerated.
- Able to understand and provide informed consent.
- Has access to phone (voice or text) or email to communicate with research staff.
Who cannot join
- Under age 18 or over age 70 at time of recruitment.
- Currently enrolled in an opioid treatment program using medications.
- Has not used opioids (prescription type or heroin) in the past 6 months prior to incarceration.
- Unwilling to allow access to medical or drug treatment records, criminal history or criminal activity records.
- Inability to communicate in English verbally.
- Inability to provide adequate contact information to assist with follow-up.
Show all 9Show fewer
- Not planning on being in King County or reporting to community corrections in King County for 6 months.
- Violent or overtly hostile/threatening towards research staff.
- Entering a controlled environment for 31 days or more in the next 6 months.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
DOC Community Field Office
Auburn, Washington, 98002
DOC Community Field Office
Burien, Washington, 98166
DOC Community Field Office
Federal Way, Washington, 98032
DOC Community Field Office
Kent, Washington, 98032
DOC Community Field Office
Renton, Washington, 98057
About this study
Official title: Treatment Navigation for Recently Released Prisoners With Opioid Use Disorder
The investigators will conduct a pilot randomized controlled trial (RCT) study of 100 people with a history of opioid use disorder releasing to WA Department of Corrections (DOC) community corrections supervision in King County. Half of the subjects will receive treatment as usual (e.g. referral to treatment or outpatient drug counseling by DOC community corrections staff) and half will receive 6 months of intervention. The intervention involves treatment decision making, in which the study interventionists help subjects understand treatment choices, decide on the treatment that is best for them, get enrolled in treatment and remain in treatment. The study does not provide treatment, but works with treatment providers to facilitate access to care.
The aims of this study are to determine: 1) whether study procedures can be implemented with as designed, 2) whether offenders can be enrolled and maintained in the study, 3) which medications/treatment options subjects select and their experiences and satisfaction with the interventions, and 4) preliminary intervention effect size on outcomes of interest including recidivism, drug use, hospitalization, and treatment enrollment and retention.
- Conditions
- Opioid-use Disorder
- Being tested
- Treatment Navigation (Intervention), Control
- 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.
Treatment Navigation (Intervention)Behavioural
Also called Treatment Navigation, Treatment Decision Making, Shared Decision Making
Subjects in the intervention arm will begin a discussion with the interventionist about whether they are interested in treatment and medication choices for opioid use disorder. The interventionist will use a decision tool informed by the Substance Abuse and Mental Health Services Administration (SAMSHA) guide to medication assisted treatment in order to help make an informed decision about treatment choices. Once a decision is reached, the Treatment Navigator will communicate with the subject periodically to assist with entering treatment and help with locating other social services as needed within the community. The Treatment Navigator will emphasize getting into treatment as quickly as possible once a decision is made. The Treatment Navigator and the subject will continue communicating throughout the 6 month study period. Subjects will also receive overdose education and be offered take-home naloxone.
ControlOther
Subjects in the control arm will receive referrals from Department of Corrections (DOC) staff for treatment per DOC protocols. Subjects will not receive any treatment navigation or treatment decision making. Subjects will also receive overdose education and be offered take-home naloxone.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Initial discussion regarding opioid treatment options followed by 6 months of treatment navigation. Receives: Behavioral: Treatment Navigation (Intervention) |
| Control | Other | Referrals to treatment from corrections staff. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Feasibility
The number of potentially eligible subjects self-referred or identified by Department of Corrections whom study staff were able to contact, screen, determine to be eligible and enroll in the study at Community Corrections facilities.
Measured: 6 months
Secondary outcomes (8)
Criminal Activity
The rate of arrests, charges and/or convictions for the comparison group versus the intervention group accounting for various potential residual confounders.
Measured: 1 month
Criminal Activity
The rate of arrests, charges and/or convictions for the comparison group versus the intervention group accounting for various potential residual confounders.
Measured: 6 months
Hospitalizations
The rate of hospitalizations for the comparison group versus the intervention group accounting for various potential residual confounders.
Measured: 1 month
Hospitalizations
The rate of hospitalizations for the comparison group versus the intervention group accounting for various potential residual confounders.
Measured: 6 months
Treatment Enrollment
The rate of treatment enrollment for the comparison group versus the intervention group accounting for various potential residual confounders.
Measured: 1 month
Treatment Enrollment
The rate of treatment enrollment for the comparison group versus the intervention group accounting for various potential residual confounders.
Measured: 6 months
Relapse Prevention Medication Prescriptions
The rate of medication initiation for the comparison group versus the intervention group accounting for various potential residual confounders.
Measured: 1 month
Relapse Prevention Medication Prescriptions
The rate of medication initiation for the comparison group versus the intervention group accounting for various potential residual confounders.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start20 Mar 2017
- Primary completion31 Dec 2017
- Study completion13 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caleb Banta-Green, University of Washington
- Investigators
- Caleb Banta-Green, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398265
- Sponsor's protocol ID
- STUDY00000227
- Status last verified
- Jun 2021
- First submitted
- 5 Oct 2017
- Last updated
- 20 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Navigation for Recently Released Prisoners With Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT03398265
- Acronym / sponsor ID
- STUDY00000227
- Conditions
- Opioid-use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 13 Sep 2019 (actual)
- First posted
- 12 Jan 2018 (actual)
- Results
- Posted 20 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will conduct a pilot randomized controlled trial (RCT) study of 100 people with a history of opioid use disorder releasing to WA Department of Corrections (DOC) community corrections supervision in King County. Half of the subjects will receive treatment as usual (e.g. referral to treatment or outpatient drug counseling by DOC community corrections staff) and half will receive 6 months of intervention. The intervention involves treatment decision making, in which the study interventionists help subjects understand treatment choices, decide on the treatment that is best for them, get enrolled in treatment and remain in treatment. The study does not provide treatment, but works with treatment providers to facilitate access to care.
The aims of this study are to determine: 1) whether study procedures can be implemented with as designed, 2) whether offenders can be enrolled and maintained in the study, 3) which medications/treatment options subjects select and their experiences and satisfaction with the interventions, and 4) preliminary intervention effect size on outcomes of interest including recidivism, drug use, hospitalization, and treatment enrollment and retention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Treatment Navigation (Intervention)Initial discussion regarding opioid treatment options followed by 6 months of treatment navigation. |
| Control | Other | Other: ControlReferrals to treatment from corrections staff. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meets Diagnostic and Statistical Manual (DSM-5) criteria for opioid use disorder (at least 2 criteria) or were receiving treatment for opioid use disorder in the 12 months prior to incarceration.
- Released to community corrections, not currently incarcerated.
- Able to understand and provide informed consent.
- Has access to phone (voice or text) or email to communicate with research staff.
Key exclusion criteria (9 listed)
- Under age 18 or over age 70 at time of recruitment.
- Currently enrolled in an opioid treatment program using medications.
- Has not used opioids (prescription type or heroin) in the past 6 months prior to incarceration.
- Unwilling to allow access to medical or drug treatment records, criminal history or criminal activity records.
- Inability to communicate in English verbally.
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 |
|---|---|---|
| Treatment Navigation (Intervention)Also: Treatment Navigation, Treatment Decision Making, Shared Decision MakingSubjects in the intervention arm will begin a discussion with the interventionist about whether they are interested in treatment and medication choices for opioid use disorder. The interventionist will use a decision tool informed by the Substance Abuse and Mental Health Services Administration (SAMSHA) guide to medication assisted treatment in order to help make an informed decision about treatment choices. Once a decision is reached, the Treatment Navigator will communicate with the subject periodically to assist with entering treatment and help with locating other social services as needed within the community. The Treatment Navigator will emphasize getting into treatment as quickly as possible once a decision is made. The Treatment Navigator and the subject will continue communicating throughout the 6 month study period. Subjects will also receive overdose education and be offered take-home naloxone. | Behavioural | Intervention |
| ControlSubjects in the control arm will receive referrals from Department of Corrections (DOC) staff for treatment per DOC protocols. Subjects will not receive any treatment navigation or treatment decision making. Subjects will also receive overdose education and be offered take-home naloxone. | Other | Control |
Primary outcome
Intervention Feasibility
Time frame: 6 months
The number of potentially eligible subjects self-referred or identified by Department of Corrections whom study staff were able to contact, screen, determine to be eligible and enroll in the study at Community Corrections facilities.
8 secondary outcomes
Criminal Activity
Time frame: 1 month
Criminal Activity
Time frame: 6 months
Hospitalizations
Time frame: 1 month
Hospitalizations
Time frame: 6 months
Treatment Enrollment
Time frame: 1 month
Treatment Enrollment
Time frame: 6 months
Relapse Prevention Medication Prescriptions
Time frame: 1 month
Relapse Prevention Medication Prescriptions
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Caleb Banta-Green, PhD principal investigator
University of Washington
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment Navigation (Intervention) in people with Opioid-use Disorder, run by University of Washington at 5 sites 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 4 inclusion and 9 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 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Yes. Results are posted in the registry (first posted 20 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Intervention Feasibility (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2021.