Clinical trial NCT03398265: Treatment Navigation for Opioid Use Disorder
Official title: Treatment Navigation for Recently Released Prisoners With Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2018-01-12
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Intervention Feasibility
timeFrame: 6 months
Secondary outcomes:
measure: Criminal Activity
timeFrame: 1 month
measure: Criminal Activity
timeFrame: 6 months
measure: Hospitalizations
timeFrame: 1 month
measure: Hospitalizations
timeFrame: 6 months
measure: Treatment Enrollment
timeFrame: 1 month
measure: Treatment Enrollment
timeFrame: 6 months
measure: Relapse Prevention Medication Prescriptions
timeFrame: 1 month
measure: Relapse Prevention Medication Prescriptions
timeFrame: 6 months
Other outcomes:
Locations:
city: Auburn
country: United States
facility: DOC Community Field Office
state: Washington
city: Burien
country: United States
facility: DOC Community Field Office
state: Washington
city: Federal Way
country: United States
facility: DOC Community Field Office
state: Washington
city: Kent
country: United States
facility: DOC Community Field Office
state: Washington
city: Renton
country: United States
facility: DOC Community Field Office
state: Washington
Study officials:
affiliation: University of Washington
name: Caleb Banta-Green, PhD
role: PRINCIPAL_INVESTIGATOR
References: