Opioid-use Disorder
Conditions
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.
Interventions
BEHAVIORALTreatment 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.
OTHERControl
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.
Sponsors
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Feasibility | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Criminal Activity | 1 month | The rate of arrests, charges and/or convictions for the comparison group versus the intervention group accounting for various potential residual confounders. |
| Hospitalizations | 1 month | The rate of hospitalizations for the comparison group versus the intervention group accounting for various potential residual confounders. |
| Treatment Enrollment | 1 month | The rate of treatment enrollment for the comparison group versus the intervention group accounting for various potential residual confounders. |
| Relapse Prevention Medication Prescriptions | 1 month | The rate of medication initiation for the comparison group versus the intervention group accounting for various potential residual confounders. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 7 |
| 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. | 8 |
| Total | 15 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Continuous | 36.6 years STANDARD_DEVIATION 7.3 | 37.1 years STANDARD_DEVIATION 9.6 | 36.9 years STANDARD_DEVIATION 8.3 |
| Days of opioid use in last 30 days prior to incarceration Mean days used heroin | 24.8 days STANDARD_DEVIATION 10.4 | 30 days STANDARD_DEVIATION 0 | 27.8 days STANDARD_DEVIATION 6.9 |
| Days of opioid use in last 30 days prior to incarceration Mean days used prescription opioids | 19.8 days STANDARD_DEVIATION 13.9 | 11.7 days STANDARD_DEVIATION 15.9 | 16.8 days STANDARD_DEVIATION 14.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 8 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 7 Participants | 6 Participants | 13 Participants |
| Region of Enrollment United States | 7 participants | 8 participants | 15 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 7 Participants | 8 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 8 |
| other Total, other adverse events | 0 / 7 | 0 / 8 |
| serious Total, serious adverse events | 0 / 7 | 0 / 8 |
Outcome results
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.
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Intervention Feasibility | 7 Participants |
| Control | Intervention Feasibility | 8 Participants |
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.
Time frame: 1 month
Population: Criminal activity data were not obtainable and therefore analyses were not conducted.
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.
Time frame: 6 months
Population: Criminal activity data were not obtainable and therefore analyses were not conducted.
Secondary
Hospitalizations
The rate of hospitalizations for the comparison group versus the intervention group accounting for various potential residual confounders.
Time frame: 6 months
Population: Hospitalization data were not obtainable and therefore analyses were not conducted.
Secondary
Hospitalizations
The rate of hospitalizations for the comparison group versus the intervention group accounting for various potential residual confounders.
Time frame: 1 month
Population: Hospitalization data were not obtainable and therefore analyses were not conducted.
Secondary
Relapse Prevention Medication Prescriptions
The rate of medication initiation for the comparison group versus the intervention group accounting for various potential residual confounders.
Time frame: 1 month
Population: Relapse prevention medication prescription data were not obtainable and therefore analyses were not conducted.
Secondary
Relapse Prevention Medication Prescriptions
The rate of medication initiation for the comparison group versus the intervention group accounting for various potential residual confounders.
Time frame: 6 months
Population: Relapse prevention medication prescription data were not obtainable and therefore analyses were not conducted.
Secondary
Treatment Enrollment
The rate of treatment enrollment for the comparison group versus the intervention group accounting for various potential residual confounders.
Time frame: 1 month
Population: Treatment enrollment data were not obtainable and therefore analyses were not conducted.
Secondary
Treatment Enrollment
The rate of treatment enrollment for the comparison group versus the intervention group accounting for various potential residual confounders.
Time frame: 6 months
Population: Because intervention feasibility was not demonstrated, treatment enrollment data were not obtained, and analyses were not conducted.