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Treatment Navigation for Opioid Use Disorder

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University of Washington

Status

Completed

Conditions

Opioid-use Disorder

Treatments

Behavioral: Treatment Navigation (Intervention)
Other: Control

Study type

Interventional

Funder types

Other

Identifiers

NCT03398265
STUDY00000227

Details and patient eligibility

About

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.

Enrollment

17 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

17 participants in 2 patient groups

Intervention
Experimental group
Description:
Initial discussion regarding opioid treatment options followed by 6 months of treatment navigation.
Treatment:
Behavioral: Treatment Navigation (Intervention)
Control
Other group
Description:
Referrals to treatment from corrections staff.
Treatment:
Other: Control

Trial documents
1

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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