Opioid-use Disorder Clinical Trial
Official title:
Treatment Navigation for Recently Released Prisoners With Opioid Use Disorder
Verified date | June 2021 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 17 |
Est. completion date | September 13, 2019 |
Est. primary completion date | December 31, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. 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. 2. Released to community corrections, not currently incarcerated. 3. Able to understand and provide informed consent. 4. Has access to phone (voice or text) or email to communicate with research staff. Exclusion Criteria: 1. Under age 18 or over age 70 at time of recruitment. 2. Currently enrolled in an opioid treatment program using medications. 3. Has not used opioids (prescription type or heroin) in the past 6 months prior to incarceration. 4. Unwilling to allow access to medical or drug treatment records, criminal history or criminal activity records. 5. Inability to communicate in English verbally. 6. Inability to provide adequate contact information to assist with follow-up. 7. Not planning on being in King County or reporting to community corrections in King County for 6 months. 8. Violent or overtly hostile/threatening towards research staff. 9. Entering a controlled environment for 31 days or more in the next 6 months. |
Country | Name | City | State |
---|---|---|---|
United States | DOC Community Field Office | Auburn | Washington |
United States | DOC Community Field Office | Burien | Washington |
United States | DOC Community Field Office | Federal Way | Washington |
United States | DOC Community Field Office | Kent | Washington |
United States | DOC Community Field Office | Renton | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | 6 months | |
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. | 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. | 6 months | |
Secondary | Hospitalizations | The rate of hospitalizations for the comparison group versus the intervention group accounting for various potential residual confounders. | 1 month | |
Secondary | Hospitalizations | The rate of hospitalizations for the comparison group versus the intervention group accounting for various potential residual confounders. | 6 months | |
Secondary | Treatment Enrollment | The rate of treatment enrollment for the comparison group versus the intervention group accounting for various potential residual confounders. | 1 month | |
Secondary | Treatment Enrollment | The rate of treatment enrollment for the comparison group versus the intervention group accounting for various potential residual confounders. | 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. | 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. | 6 months |
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