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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Initial discussion regarding opioid treatment options followed by 6 months of treatment navigation. |
|
| Control | Other | Referrals to treatment from corrections staff. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment Navigation (Intervention) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Criminal Activity | The rate of arrests, charges and/or convictions for the comparison group versus the intervention group accounting for various potential residual confounders. | 1 month |
| Criminal Activity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Caleb Banta-Green, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DOC Community Field Office | Auburn | Washington | 98002 | United States | ||
| DOC Community Field Office |
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125 people releasing from prison were identified by Washington Department of Corrections with notifications sent to local community corrections officers of their approximate release dates. Of the 125 people releasing from prison, 63 were approached for study participation. Of the 63 who were approached, 44 declined participation or were not opioid users. Of the remaining 19 who were assessed, 2 were ineligible and 17 were consented. Of the 17 who were consented, 15 were assigned to groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Initial discussion regarding opioid treatment options followed by 6 months of treatment navigation. Treatment Navigation (Intervention): 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. |
| FG001 | Control | Referrals to treatment from corrections staff. Control: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Initial discussion regarding opioid treatment options followed by 6 months of treatment navigation. Treatment Navigation (Intervention): 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Of the 125 people releasing from prison, 63 were approached for study participation. Of the 63 who were approached, 44 declined participation or were not opioid users. Of the remaining 19 who were assessed, 2 were ineligible and 17 were consented. Of the 17 who were consented, 2 declined participation and15 were assigned to groups. The 15 assigned to groups were included in the analysis. | Posted | Count of Participants | Participants | 6 months |
|
Nine months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Initial discussion regarding opioid treatment options followed by 6 months of treatment navigation. Treatment Navigation (Intervention): 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Caleb Banta-Green | University of Washington | 206-543-0937 | calebbg@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 20, 2017 | Dec 17, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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|
|
| Control | Other | 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. |
|
The rate of arrests, charges and/or convictions for the comparison group versus the intervention group accounting for various potential residual confounders.
| 6 months |
| Hospitalizations | The rate of hospitalizations for the comparison group versus the intervention group accounting for various potential residual confounders. | 1 month |
| Hospitalizations | The rate of hospitalizations for the comparison group versus the intervention group accounting for various potential residual confounders. | 6 months |
| Treatment Enrollment | The rate of treatment enrollment for the comparison group versus the intervention group accounting for various potential residual confounders. | 1 month |
| Treatment Enrollment | The rate of treatment enrollment for the comparison group versus the intervention group accounting for various potential residual confounders. | 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. | 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. | 6 months |
| Burien |
| Washington |
| 98166 |
| United States |
| DOC Community Field Office | Federal Way | Washington | 98032 | United States |
| DOC Community Field Office | Kent | Washington | 98032 | United States |
| DOC Community Field Office | Renton | Washington | 98057 | United States |
| BG001 | Control | Referrals to treatment from corrections staff. Control: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Days of opioid use in last 30 days prior to incarceration | Mean | Standard Deviation | days |
|
| OG001 | Control | Referrals to treatment from corrections staff. Control: 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. |
|
|
| Secondary | Criminal Activity | The rate of arrests, charges and/or convictions for the comparison group versus the intervention group accounting for various potential residual confounders. | Criminal activity data were not obtainable and therefore analyses were not conducted. | Posted | 1 month |
|
|
| Secondary | Criminal Activity | The rate of arrests, charges and/or convictions for the comparison group versus the intervention group accounting for various potential residual confounders. | Criminal activity data were not obtainable and therefore analyses were not conducted. | Posted | 6 months |
|
|
| Secondary | Hospitalizations | The rate of hospitalizations for the comparison group versus the intervention group accounting for various potential residual confounders. | Hospitalization data were not obtainable and therefore analyses were not conducted. | Posted | 1 month |
|
|
| Secondary | Hospitalizations | The rate of hospitalizations for the comparison group versus the intervention group accounting for various potential residual confounders. | Hospitalization data were not obtainable and therefore analyses were not conducted. | Posted | 6 months |
|
|
| Secondary | Treatment Enrollment | The rate of treatment enrollment for the comparison group versus the intervention group accounting for various potential residual confounders. | Treatment enrollment data were not obtainable and therefore analyses were not conducted. | Posted | 1 month |
|
|
| Secondary | Treatment Enrollment | The rate of treatment enrollment for the comparison group versus the intervention group accounting for various potential residual confounders. | Because intervention feasibility was not demonstrated, treatment enrollment data were not obtained, and analyses were not conducted. | Posted | 6 months |
|
|
| Secondary | Relapse Prevention Medication Prescriptions | The rate of medication initiation for the comparison group versus the intervention group accounting for various potential residual confounders. | Relapse prevention medication prescription data were not obtainable and therefore analyses were not conducted. | Posted | 1 month |
|
|
| Secondary | Relapse Prevention Medication Prescriptions | The rate of medication initiation for the comparison group versus the intervention group accounting for various potential residual confounders. | Relapse prevention medication prescription data were not obtainable and therefore analyses were not conducted. | Posted | 6 months |
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Control | Referrals to treatment from corrections staff. Control: 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. | 0 | 8 | 0 | 8 | 0 | 8 |
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