Trial Outcomes & Findings for Treatment Navigation for Opioid Use Disorder (NCT NCT03398265)

Last Updated: 2021-07-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

17 participants

Primary outcome timeframe

6 months

Results posted on

2021-07-20

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	7	8
Overall Study COMPLETED	7	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment Navigation for Opioid Use Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=7 Participants 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.	Control n=8 Participants 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.	Total n=15 Participants Total of all reporting groups
Age, Continuous	36.6 years STANDARD_DEVIATION 7.3 • n=5 Participants	37.1 years STANDARD_DEVIATION 9.6 • n=7 Participants	36.9 years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants	8 participants n=7 Participants	15 participants n=5 Participants
Days of opioid use in last 30 days prior to incarceration Mean days used heroin	24.8 days STANDARD_DEVIATION 10.4 • n=5 Participants	30 days STANDARD_DEVIATION 0 • n=7 Participants	27.8 days STANDARD_DEVIATION 6.9 • n=5 Participants
Days of opioid use in last 30 days prior to incarceration Mean days used prescription opioids	19.8 days STANDARD_DEVIATION 13.9 • n=5 Participants	11.7 days STANDARD_DEVIATION 15.9 • n=7 Participants	16.8 days STANDARD_DEVIATION 14.2 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention n=7 Participants 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.	Control n=8 Participants 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.
Intervention Feasibility	7 Participants	8 Participants

SECONDARY outcome

Timeframe: 1 month

Population: Criminal activity data were not obtainable and therefore analyses were not conducted.

The rate of arrests, charges and/or convictions for the comparison group versus the intervention group accounting for various potential residual confounders.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Criminal activity data were not obtainable and therefore analyses were not conducted.

The rate of arrests, charges and/or convictions for the comparison group versus the intervention group accounting for various potential residual confounders.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 month

Population: Hospitalization data were not obtainable and therefore analyses were not conducted.

The rate of hospitalizations for the comparison group versus the intervention group accounting for various potential residual confounders.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Hospitalization data were not obtainable and therefore analyses were not conducted.

The rate of hospitalizations for the comparison group versus the intervention group accounting for various potential residual confounders.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 month

Population: Treatment enrollment data were not obtainable and therefore analyses were not conducted.

The rate of treatment enrollment for the comparison group versus the intervention group accounting for various potential residual confounders.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Because intervention feasibility was not demonstrated, treatment enrollment data were not obtained, and analyses were not conducted.

The rate of treatment enrollment for the comparison group versus the intervention group accounting for various potential residual confounders.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 month

Population: Relapse prevention medication prescription data were not obtainable and therefore analyses were not conducted.

The rate of medication initiation for the comparison group versus the intervention group accounting for various potential residual confounders.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Relapse prevention medication prescription data were not obtainable and therefore analyses were not conducted.

The rate of medication initiation for the comparison group versus the intervention group accounting for various potential residual confounders.

Outcome measures

Outcome data not reported

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Caleb Banta-Green

University of Washington

Phone: 206-543-0937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place