Trial Outcomes & Findings for Project OOPEN: Opioid Overdose Prevention, Education and Intervention (NCT NCT01788306)

NCT ID: NCT01788306

Last Updated: 2022-01-11

Results Overview

Rate of fatal opioid overdose

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 256 participants
• Primary outcome timeframe: One year
• Results posted on: 2022-01-11

Participant Flow

Participant milestones

Measure	Intervention (OOPEN+BBCC) Study intervention, overdose prevention, education, intervention, brief behavioral change counseling, take-home naloxone, referral to local available resources. OOPEN+BBCC: Take-home naloxone is offered as part of a behavioral prevention intervention to reduce the occurrence of future opioid overdose.	Control Standard of care, referral to local available resources.
Overall Study STARTED	125	131
Overall Study COMPLETED	115	126
Overall Study NOT COMPLETED	10	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Project OOPEN: Opioid Overdose Prevention, Education and Intervention

Baseline characteristics by cohort

Measure	Intervention (OOPEN+BBCC) n=115 Participants Study intervention, overdose prevention, education, intervention, brief behavioral change counseling, take-home naloxone, referral to local available resources. OOPEN+BBCC: Take-home naloxone is offered as part of a behavioral prevention intervention to reduce the occurrence of future opioid overdose.	Control n=126 Participants Standard of care, referral to local available resources.	Total n=241 Participants Total of all reporting groups
Age, Continuous	40.2 years STANDARD_DEVIATION 11.5 • n=5 Participants	42.3 years STANDARD_DEVIATION 11.5 • n=7 Participants	41.3 years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	37 Participants n=7 Participants	69 Participants n=5 Participants
Sex: Female, Male Male	83 Participants n=5 Participants	89 Participants n=7 Participants	172 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=5 Participants	21 Participants n=7 Participants	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	101 Participants n=5 Participants	105 Participants n=7 Participants	206 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	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	17 Participants n=5 Participants	14 Participants n=7 Participants	31 Participants n=5 Participants
Race (NIH/OMB) White	60 Participants n=5 Participants	67 Participants n=7 Participants	127 Participants n=5 Participants
Race (NIH/OMB) More than one race	18 Participants n=5 Participants	19 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants
Region of Enrollment United States	115 participants n=5 Participants	126 participants n=7 Participants	241 participants n=5 Participants
Opioid overdose past 3 months	19 Participants n=5 Participants	27 Participants n=7 Participants	46 Participants n=5 Participants

PRIMARY outcome

Timeframe: One year

Population: Number of participants experiencing fatal opioid overdose.

Rate of fatal opioid overdose

Outcome measures

Measure	Intervention (OOPEN+BBCC) n=115 Participants Study intervention, overdose prevention, education, intervention, brief behavioral change counseling, take-home naloxone, referral to local available resources. OOPEN+BBCC: Take-home naloxone is offered as part of a behavioral prevention intervention to reduce the occurrence of future opioid overdose.	Control n=126 Participants Standard of care, referral to local available resources.	Control - Permanent or Stable Housing Standard of care, referral to local available resources.	Control - Temporary or Unstable Housing or Unhoused. Standard of care, referral to local available resources.
Rate of Fatal Opioid Overdose	2 Participants	6 Participants	—	—

PRIMARY outcome

Timeframe: One year

Population: Number of participants experiencing non-fatal opioid overdose.

Rate of non-fatal opioid overdose

Outcome measures

Measure	Intervention (OOPEN+BBCC) n=115 Participants Study intervention, overdose prevention, education, intervention, brief behavioral change counseling, take-home naloxone, referral to local available resources. OOPEN+BBCC: Take-home naloxone is offered as part of a behavioral prevention intervention to reduce the occurrence of future opioid overdose.	Control n=126 Participants Standard of care, referral to local available resources.	Control - Permanent or Stable Housing Standard of care, referral to local available resources.	Control - Temporary or Unstable Housing or Unhoused. Standard of care, referral to local available resources.
Rate of Non-fatal Opioid Overdose	22 Participants	27 Participants	—	—

PRIMARY outcome

Timeframe: Up to1064 days

Population: Mean days to first overdose event

Elapsed time until opioid overdose

Outcome measures

Measure	Intervention (OOPEN+BBCC) n=115 Participants Study intervention, overdose prevention, education, intervention, brief behavioral change counseling, take-home naloxone, referral to local available resources. OOPEN+BBCC: Take-home naloxone is offered as part of a behavioral prevention intervention to reduce the occurrence of future opioid overdose.	Control n=126 Participants Standard of care, referral to local available resources.	Control - Permanent or Stable Housing Standard of care, referral to local available resources.	Control - Temporary or Unstable Housing or Unhoused. Standard of care, referral to local available resources.
Elapsed Time Until Opioid Overdose	870 days Interval 272.0 to 1064.0	836 days Interval 272.0 to 1064.0	—	—

PRIMARY outcome

Timeframe: 3 months

Population: Participants reporting change in heroin use: "Compared to the last time you spoke with research staff 3 months ago, do you use heroin..."

Determine whether changes in behavior occur that increase or decrease risk of future overdose. Behaviors being measured include the amount of opioids taken, the use of opioids alone, use of opioids with alcohol or other drugs or medications, possessing naloxone, use of opioids in an environment that supports continued opioid use.(Data table includes proportions at 3 month follow-up.)

Outcome measures

Measure	Intervention (OOPEN+BBCC) n=30 Participants Study intervention, overdose prevention, education, intervention, brief behavioral change counseling, take-home naloxone, referral to local available resources. OOPEN+BBCC: Take-home naloxone is offered as part of a behavioral prevention intervention to reduce the occurrence of future opioid overdose.	Control n=29 Participants Standard of care, referral to local available resources.	Control - Permanent or Stable Housing Standard of care, referral to local available resources.	Control - Temporary or Unstable Housing or Unhoused. Standard of care, referral to local available resources.
Change in Overdose Risk (Change in Opioid Use - Heroin) More	6 Participants	4 Participants	—	—
Change in Overdose Risk (Change in Opioid Use - Heroin) Less	14 Participants	17 Participants	—	—
Change in Overdose Risk (Change in Opioid Use - Heroin) Same Amount	7 Participants	7 Participants	—	—
Change in Overdose Risk (Change in Opioid Use - Heroin) Don't Know	3 Participants	1 Participants	—	—
Change in Overdose Risk (Change in Opioid Use - Heroin) N/A (was not using previously)	0 Participants	0 Participants	—	—

PRIMARY outcome

Timeframe: 3 months

Population: Participants reporting change in prescription-type opioid use: "Compared to the last time you spoke with research staff 3 months ago, do you use prescription-type medications..."

Determine whether changes in behavior occur that increase or decrease risk of future overdose. Behaviors being measured include the amount of opioids taken, the use of opioids alone, use of opioids with alcohol or other drugs or medications, possessing naloxone, use of opioids in an environment that supports continued opioid use.(Data table includes proportions at 3 month follow-up.)

Outcome measures

Measure	Intervention (OOPEN+BBCC) n=35 Participants Study intervention, overdose prevention, education, intervention, brief behavioral change counseling, take-home naloxone, referral to local available resources. OOPEN+BBCC: Take-home naloxone is offered as part of a behavioral prevention intervention to reduce the occurrence of future opioid overdose.	Control n=39 Participants Standard of care, referral to local available resources.	Control - Permanent or Stable Housing Standard of care, referral to local available resources.	Control - Temporary or Unstable Housing or Unhoused. Standard of care, referral to local available resources.
Change in Overdose Risk (Change in Opioid Use - Prescription-Type Opioids) More	7 Participants	9 Participants	—	—
Change in Overdose Risk (Change in Opioid Use - Prescription-Type Opioids) Less	12 Participants	11 Participants	—	—
Change in Overdose Risk (Change in Opioid Use - Prescription-Type Opioids) Same Amount	12 Participants	16 Participants	—	—
Change in Overdose Risk (Change in Opioid Use - Prescription-Type Opioids) Don't know Don't Know	2 Participants	3 Participants	—	—
Change in Overdose Risk (Change in Opioid Use - Prescription-Type Opioids) N/A (was not using previously)	2 Participants	0 Participants	—	—

PRIMARY outcome

Timeframe: 3 months

Population: Mean days using opioids alone, among people who used one or more days in the past 30, "In the past 30 days, how many days have you used opioids when nobody else was around?"

Determine whether changes in behavior occur that increase or decrease risk of future overdose. Behaviors being measured include the amount of opioids taken, the use of opioids alone, use of opioids with alcohol or other drugs or medications, possessing naloxone, use of opioids in an environment that supports continued opioid use. (Data table includes means at 3 month follow-up.)

Outcome measures

Measure	Intervention (OOPEN+BBCC) n=97 Participants Study intervention, overdose prevention, education, intervention, brief behavioral change counseling, take-home naloxone, referral to local available resources. OOPEN+BBCC: Take-home naloxone is offered as part of a behavioral prevention intervention to reduce the occurrence of future opioid overdose.	Control n=103 Participants Standard of care, referral to local available resources.	Control - Permanent or Stable Housing Standard of care, referral to local available resources.	Control - Temporary or Unstable Housing or Unhoused. Standard of care, referral to local available resources.
Change in Overdose Risk (Using Alone When Taking Opioids) Baseline	17.9 days in the past 30 Standard Deviation 10.5	15.6 days in the past 30 Standard Deviation 10.9	—	—
Change in Overdose Risk (Using Alone When Taking Opioids) Follow-up	16.5 days in the past 30 Standard Deviation 10.9	16.7 days in the past 30 Standard Deviation 10.7	—	—

PRIMARY outcome

Timeframe: 3 months

Population: Use of sedatives when taking opioids, "When you use opioids, how often do you use sedatives or downers within 2 hours before or after?" .

Determine whether changes in behavior occur that increase or decrease risk of future overdose. Behaviors being measured include the amount of opioids taken, the use of opioids alone, use of opioids with alcohol or other drugs or medications, possessing naloxone, use of opioids in an environment that supports continued opioid use. (Data table includes proportions at 3 month follow-up.)

Outcome measures

Measure	Intervention (OOPEN+BBCC) n=125 Participants Study intervention, overdose prevention, education, intervention, brief behavioral change counseling, take-home naloxone, referral to local available resources. OOPEN+BBCC: Take-home naloxone is offered as part of a behavioral prevention intervention to reduce the occurrence of future opioid overdose.	Control n=131 Participants Standard of care, referral to local available resources.	Control - Permanent or Stable Housing Standard of care, referral to local available resources.	Control - Temporary or Unstable Housing or Unhoused. Standard of care, referral to local available resources.
Change in Overdose Risk (Use of Sedatives When Taking Opioids) Baseline: Always	11 Participants	11 Participants	—	—
Change in Overdose Risk (Use of Sedatives When Taking Opioids) Baseline: Sometimes	41 Participants	53 Participants	—	—
Change in Overdose Risk (Use of Sedatives When Taking Opioids) Baseline: Never	73 Participants	67 Participants	—	—
Change in Overdose Risk (Use of Sedatives When Taking Opioids) Follow-up: Always	2 Participants	2 Participants	—	—
Change in Overdose Risk (Use of Sedatives When Taking Opioids) Follow-up: Sometimes	15 Participants	11 Participants	—	—
Change in Overdose Risk (Use of Sedatives When Taking Opioids) Follow-up: Never	39 Participants	45 Participants	—	—

PRIMARY outcome

Timeframe: 3 months

Population: Use of alcohol when taking opioids, "When you use opioids, how often do drink alcohol with 2 hours before or after?"

Determine whether changes in behavior occur that increase or decrease risk of future overdose. Behaviors being measured include the amount of opioids taken, the use of opioids alone, use of opioids with alcohol or other drugs or medications, possessing naloxone, use of opioids in an environment that supports continued opioid use.(Data table includes proportions at 3 month follow-up.)

Outcome measures

Measure	Intervention (OOPEN+BBCC) n=125 Participants Study intervention, overdose prevention, education, intervention, brief behavioral change counseling, take-home naloxone, referral to local available resources. OOPEN+BBCC: Take-home naloxone is offered as part of a behavioral prevention intervention to reduce the occurrence of future opioid overdose.	Control n=131 Participants Standard of care, referral to local available resources.	Control - Permanent or Stable Housing Standard of care, referral to local available resources.	Control - Temporary or Unstable Housing or Unhoused. Standard of care, referral to local available resources.
Change in Overdose Risk (Use of Alcohol When Taking Opioids) Baseline: Always	8 Participants	19 Participants	—	—
Change in Overdose Risk (Use of Alcohol When Taking Opioids) Baseline: Sometimes	31 Participants	35 Participants	—	—
Change in Overdose Risk (Use of Alcohol When Taking Opioids) Baseline: Never	86 Participants	77 Participants	—	—
Change in Overdose Risk (Use of Alcohol When Taking Opioids) Follow-up: Always	5 Participants	4 Participants	—	—
Change in Overdose Risk (Use of Alcohol When Taking Opioids) Follow-up: Sometimes	9 Participants	9 Participants	—	—
Change in Overdose Risk (Use of Alcohol When Taking Opioids) Follow-up: Never	43 Participants	45 Participants	—	—

SECONDARY outcome

Timeframe: One year (annual rate)

Population: Annual mean number per person

Appropriate health care utilization (e.g. fewer emergency department visits and admissions to inpatient care)

Outcome measures

Measure	Intervention (OOPEN+BBCC) n=115 Participants Study intervention, overdose prevention, education, intervention, brief behavioral change counseling, take-home naloxone, referral to local available resources. OOPEN+BBCC: Take-home naloxone is offered as part of a behavioral prevention intervention to reduce the occurrence of future opioid overdose.	Control n=126 Participants Standard of care, referral to local available resources.	Control - Permanent or Stable Housing Standard of care, referral to local available resources.	Control - Temporary or Unstable Housing or Unhoused. Standard of care, referral to local available resources.
Health Care Utilization (ED and Inpatient Admissions) Emergency department visits	4.96 annual visits Interval 4.04 to 6.1	4.85 annual visits Interval 3.96 to 5.93	—	—
Health Care Utilization (ED and Inpatient Admissions) Inpatient admissions	1.29 annual visits Interval 0.95 to 1.76	1.05 annual visits Interval 0.8 to 1.39	—	—

SECONDARY outcome

Timeframe: 3 months

Population: Frequency of condom use in the past 3 months, "In the past three months, how often did you use condoms when you had sex?"

Determine whether change occurs in the number of sexual risk behaviors (such as engaging in intercourse without a condom) and/or injection use behaviors (such as sharing syringes) that may increase the risk of contracting HIV.(Data table includes proportions at 3 month follow-up.)

Outcome measures

Measure	Intervention (OOPEN+BBCC) n=71 Participants Study intervention, overdose prevention, education, intervention, brief behavioral change counseling, take-home naloxone, referral to local available resources. OOPEN+BBCC: Take-home naloxone is offered as part of a behavioral prevention intervention to reduce the occurrence of future opioid overdose.	Control n=73 Participants Standard of care, referral to local available resources.	Control - Permanent or Stable Housing Standard of care, referral to local available resources.	Control - Temporary or Unstable Housing or Unhoused. Standard of care, referral to local available resources.
Change in HIV Risk Behaviors (Condom Use) Baseline · All the time	20 Participants	14 Participants	—	—
Change in HIV Risk Behaviors (Condom Use) Baseline · Most of the time	8 Participants	6 Participants	—	—
Change in HIV Risk Behaviors (Condom Use) Baseline · Some of the time	8 Participants	5 Participants	—	—
Change in HIV Risk Behaviors (Condom Use) Baseline · None of the time	33 Participants	45 Participants	—	—
Change in HIV Risk Behaviors (Condom Use) Baseline · Not applicable/No sex past 3 months	2 Participants	3 Participants	—	—
Change in HIV Risk Behaviors (Condom Use) Follow-up · All the time	12 Participants	5 Participants	—	—
Change in HIV Risk Behaviors (Condom Use) Follow-up · Most of the time	0 Participants	1 Participants	—	—
Change in HIV Risk Behaviors (Condom Use) Follow-up · Some of the time	3 Participants	1 Participants	—	—
Change in HIV Risk Behaviors (Condom Use) Follow-up · None of the time	13 Participants	15 Participants	—	—
Change in HIV Risk Behaviors (Condom Use) Follow-up · Not applicable/No sex past 3 months	1 Participants	3 Participants	—	—

SECONDARY outcome

Timeframe: 3 months

Population: Number of participants who shared syringes or injection supplies, "In the past three months, have you shared needles or works?"

Determine whether change occurs in the number of sexual risk behaviors (such as engaging in intercourse without a condom) and/or injection use behaviors (such as sharing syringes) that may increase the risk of contracting HIV. (Data table includes proportions at 3 month follow-up.)

Outcome measures

Measure	Intervention (OOPEN+BBCC) n=102 Participants Study intervention, overdose prevention, education, intervention, brief behavioral change counseling, take-home naloxone, referral to local available resources. OOPEN+BBCC: Take-home naloxone is offered as part of a behavioral prevention intervention to reduce the occurrence of future opioid overdose.	Control n=97 Participants Standard of care, referral to local available resources.	Control - Permanent or Stable Housing Standard of care, referral to local available resources.	Control - Temporary or Unstable Housing or Unhoused. Standard of care, referral to local available resources.
Change in HIV Risk Behaviors (Shared Syringes) Baseline	29 Participants	29 Participants	—	—
Change in HIV Risk Behaviors (Shared Syringes) Follow-up	11 Participants	4 Participants	—	—

SECONDARY outcome

Timeframe: 3 Months

Population: Number of people with naloxone in the past 3 months, "At any time in the past 3 months did you have take-home naloxone?"

Change in overdose response including naloxone availability and change in overdose risk perceptions. (Data table includes proportions at 3 month follow-up.)

Outcome measures

Measure	Intervention (OOPEN+BBCC) n=57 Participants Study intervention, overdose prevention, education, intervention, brief behavioral change counseling, take-home naloxone, referral to local available resources. OOPEN+BBCC: Take-home naloxone is offered as part of a behavioral prevention intervention to reduce the occurrence of future opioid overdose.	Control n=58 Participants Standard of care, referral to local available resources.	Control - Permanent or Stable Housing Standard of care, referral to local available resources.	Control - Temporary or Unstable Housing or Unhoused. Standard of care, referral to local available resources.
Change in Overdose Risk Behaviors and Perceptions (Take Home Naloxone)	41 Participants	10 Participants	—	—

SECONDARY outcome

Timeframe: 3 Months

Population: Perception of likelihood of opioid overdose, "How likely is it that you will experience an opiate overdose in the next year?"

Change in overdose response including naloxone availability and change in overdose risk perceptions. (Data table includes proportions at 3 month follow-up.)

Outcome measures

Measure	Intervention (OOPEN+BBCC) n=64 Participants Study intervention, overdose prevention, education, intervention, brief behavioral change counseling, take-home naloxone, referral to local available resources. OOPEN+BBCC: Take-home naloxone is offered as part of a behavioral prevention intervention to reduce the occurrence of future opioid overdose.	Control n=63 Participants Standard of care, referral to local available resources.	Control - Permanent or Stable Housing Standard of care, referral to local available resources.	Control - Temporary or Unstable Housing or Unhoused. Standard of care, referral to local available resources.
Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) Baseline · Extremely/somewhat likely	12 Participants	15 Participants	—	—
Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) Baseline · Not sure	14 Participants	19 Participants	—	—
Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) Baseline · Extreme/somewhat unlikely	38 Participants	29 Participants	—	—
Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) Follow-up · Extremely/somewhat likely	1 Participants	3 Participants	—	—
Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) Follow-up · Not sure	17 Participants	6 Participants	—	—
Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) Follow-up · Extreme/somewhat unlikely	17 Participants	20 Participants	—	—

SECONDARY outcome

Timeframe: 3 Months

Population: Perception of concern about opioid overdose, "How concerned are you about YOU experiencing an overdose?"

Change in overdose response including naloxone availability and change in overdose risk perceptions. (Data table includes proportions at 3 month follow-up.)

Outcome measures

Measure	Intervention (OOPEN+BBCC) n=64 Participants Study intervention, overdose prevention, education, intervention, brief behavioral change counseling, take-home naloxone, referral to local available resources. OOPEN+BBCC: Take-home naloxone is offered as part of a behavioral prevention intervention to reduce the occurrence of future opioid overdose.	Control n=63 Participants Standard of care, referral to local available resources.	Control - Permanent or Stable Housing Standard of care, referral to local available resources.	Control - Temporary or Unstable Housing or Unhoused. Standard of care, referral to local available resources.
Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) Baseline · Extremely/somewhat concerned	24 Participants	28 Participants	—	—
Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) Baseline · Not sure	1 Participants	3 Participants	—	—
Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) Baseline · Not very/at all concerned	39 Participants	32 Participants	—	—
Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) Follow-up · Extremely/somewhat concerned	9 Participants	7 Participants	—	—
Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) Follow-up · Not sure	2 Participants	0 Participants	—	—
Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) Follow-up · Not very/at all concerned	24 Participants	22 Participants	—	—

SECONDARY outcome

Timeframe: 3 months

Population: Frequency of condom use in the past 3 months by housing status. "In the past three months, how often did you use condoms when you had sex?"

Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.)

Outcome measures

Measure	Intervention (OOPEN+BBCC) n=10 Participants Study intervention, overdose prevention, education, intervention, brief behavioral change counseling, take-home naloxone, referral to local available resources. OOPEN+BBCC: Take-home naloxone is offered as part of a behavioral prevention intervention to reduce the occurrence of future opioid overdose.	Control n=19 Participants Standard of care, referral to local available resources.	Control - Permanent or Stable Housing n=12 Participants Standard of care, referral to local available resources.	Control - Temporary or Unstable Housing or Unhoused. n=13 Participants Standard of care, referral to local available resources.
Subgroup Analyses - Change in HIV Risk Behaviors (Condom Use) All the time	4 Participants	8 Participants	2 Participants	3 Participants
Subgroup Analyses - Change in HIV Risk Behaviors (Condom Use) Most of the time	0 Participants	0 Participants	0 Participants	1 Participants
Subgroup Analyses - Change in HIV Risk Behaviors (Condom Use) Some of the time	1 Participants	2 Participants	1 Participants	0 Participants
Subgroup Analyses - Change in HIV Risk Behaviors (Condom Use) None of the time	5 Participants	8 Participants	8 Participants	7 Participants
Subgroup Analyses - Change in HIV Risk Behaviors (Condom Use) Not applicable/No sex past 3 months	0 Participants	1 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Number of participants who shared syringes or injection supplies by housing status. "In the past three months, have you shared needles or works?"

Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.)

Outcome measures

Measure	Intervention (OOPEN+BBCC) n=11 Participants Study intervention, overdose prevention, education, intervention, brief behavioral change counseling, take-home naloxone, referral to local available resources. OOPEN+BBCC: Take-home naloxone is offered as part of a behavioral prevention intervention to reduce the occurrence of future opioid overdose.	Control n=26 Participants Standard of care, referral to local available resources.	Control - Permanent or Stable Housing n=15 Participants Standard of care, referral to local available resources.	Control - Temporary or Unstable Housing or Unhoused. n=17 Participants Standard of care, referral to local available resources.
Subgroup Analyses - Change in HIV Risk Behaviors (Shared Syringes)	4 Participants	7 Participants	2 Participants	2 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Participants reporting change in heroin use by housing status: "Compared to the last time you spoke with research staff 3 months ago, do you use heroin..."

Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.)

Outcome measures

Measure	Intervention (OOPEN+BBCC) n=8 Participants Study intervention, overdose prevention, education, intervention, brief behavioral change counseling, take-home naloxone, referral to local available resources. OOPEN+BBCC: Take-home naloxone is offered as part of a behavioral prevention intervention to reduce the occurrence of future opioid overdose.	Control n=22 Participants Standard of care, referral to local available resources.	Control - Permanent or Stable Housing n=12 Participants Standard of care, referral to local available resources.	Control - Temporary or Unstable Housing or Unhoused. n=17 Participants Standard of care, referral to local available resources.
Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Heroin) More	1 Participants	5 Participants	3 Participants	1 Participants
Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Heroin) Less	4 Participants	10 Participants	6 Participants	11 Participants
Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Heroin) Same Amount	2 Participants	5 Participants	3 Participants	4 Participants
Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Heroin) Don't Know	1 Participants	2 Participants	0 Participants	1 Participants
Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Heroin) N/A (was not using previously)	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Participants reporting change in prescription-type opioids by use by housing status: "Compared to the last time you spoke with research staff 3 months ago, do you use prescription type opioids..."

Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.)

Outcome measures

Measure	Intervention (OOPEN+BBCC) n=11 Participants Study intervention, overdose prevention, education, intervention, brief behavioral change counseling, take-home naloxone, referral to local available resources. OOPEN+BBCC: Take-home naloxone is offered as part of a behavioral prevention intervention to reduce the occurrence of future opioid overdose.	Control n=24 Participants Standard of care, referral to local available resources.	Control - Permanent or Stable Housing n=24 Participants Standard of care, referral to local available resources.	Control - Temporary or Unstable Housing or Unhoused. n=15 Participants Standard of care, referral to local available resources.
Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Prescription Type Opioids) More	2 Participants	5 Participants	6 Participants	3 Participants
Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Prescription Type Opioids) Less	3 Participants	9 Participants	7 Participants	4 Participants
Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Prescription Type Opioids) Same Amount	5 Participants	7 Participants	10 Participants	6 Participants
Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Prescription Type Opioids) Don't Know	1 Participants	1 Participants	1 Participants	2 Participants
Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Prescription Type Opioids) N/A (was not using previously)	0 Participants	2 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Mean days using opioids alone, among people who used one or more days in the past 30 by housing status. "In the past 30 days, how many days have you used opioids when nobody else was around?"

Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes means at 3 month follow-up.)

Outcome measures

Measure	Intervention (OOPEN+BBCC) n=8 Participants Study intervention, overdose prevention, education, intervention, brief behavioral change counseling, take-home naloxone, referral to local available resources. OOPEN+BBCC: Take-home naloxone is offered as part of a behavioral prevention intervention to reduce the occurrence of future opioid overdose.	Control n=9 Participants Standard of care, referral to local available resources.	Control - Permanent or Stable Housing n=14 Participants Standard of care, referral to local available resources.	Control - Temporary or Unstable Housing or Unhoused. n=11 Participants Standard of care, referral to local available resources.
Sub-group Analyses - Change in Overdose Risk (Using Alone When Taking Opioids)	19.1 days in the past 30 Standard Deviation 10.8	14.2 days in the past 30 Standard Deviation 11.1	17.7 days in the past 30 Standard Deviation 10.8	15.4 days in the past 30 Standard Deviation 11.0

SECONDARY outcome

Timeframe: 3 months

Population: Use of sedatives when taking opioids by housing status. "When you use opioids, how often do you take sedatives or downers with 2 hours before or after?"

Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.)

Outcome measures

Measure	Intervention (OOPEN+BBCC) n=18 Participants Study intervention, overdose prevention, education, intervention, brief behavioral change counseling, take-home naloxone, referral to local available resources. OOPEN+BBCC: Take-home naloxone is offered as part of a behavioral prevention intervention to reduce the occurrence of future opioid overdose.	Control n=38 Participants Standard of care, referral to local available resources.	Control - Permanent or Stable Housing n=32 Participants Standard of care, referral to local available resources.	Control - Temporary or Unstable Housing or Unhoused. n=26 Participants Standard of care, referral to local available resources.
Subgroup Analyses- Change in Overdose Risk (Use of Sedatives When Taking Opioids) Always	1 Participants	1 Participants	0 Participants	2 Participants
Subgroup Analyses- Change in Overdose Risk (Use of Sedatives When Taking Opioids) Sometimes	6 Participants	9 Participants	3 Participants	8 Participants
Subgroup Analyses- Change in Overdose Risk (Use of Sedatives When Taking Opioids) Never	11 Participants	28 Participants	29 Participants	16 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Use of alcohol when taking opioids by housing status "When you use opioids, how often do drink alcohol with 2 hours before or after?"

Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.)

Outcome measures

Measure	Intervention (OOPEN+BBCC) n=18 Participants Study intervention, overdose prevention, education, intervention, brief behavioral change counseling, take-home naloxone, referral to local available resources. OOPEN+BBCC: Take-home naloxone is offered as part of a behavioral prevention intervention to reduce the occurrence of future opioid overdose.	Control n=39 Participants Standard of care, referral to local available resources.	Control - Permanent or Stable Housing n=32 Participants Standard of care, referral to local available resources.	Control - Temporary or Unstable Housing or Unhoused. n=26 Participants Standard of care, referral to local available resources.
Subgroup Analyses- Change in Overdose Risk (Use of Alcohol When Taking Opioids) Always	1 Participants	4 Participants	3 Participants	1 Participants
Subgroup Analyses- Change in Overdose Risk (Use of Alcohol When Taking Opioids) Sometimes	1 Participants	8 Participants	3 Participants	6 Participants
Subgroup Analyses- Change in Overdose Risk (Use of Alcohol When Taking Opioids) Never	16 Participants	27 Participants	26 Participants	19 Participants

SECONDARY outcome

Timeframe: 3 Months

Population: Number of people with naloxone in the past 3 months by housing status. "At any time in the past 3 months did you have take-home naloxone?"

Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.)

Outcome measures

Measure	Intervention (OOPEN+BBCC) n=18 Participants Study intervention, overdose prevention, education, intervention, brief behavioral change counseling, take-home naloxone, referral to local available resources. OOPEN+BBCC: Take-home naloxone is offered as part of a behavioral prevention intervention to reduce the occurrence of future opioid overdose.	Control n=39 Participants Standard of care, referral to local available resources.	Control - Permanent or Stable Housing n=32 Participants Standard of care, referral to local available resources.	Control - Temporary or Unstable Housing or Unhoused. n=26 Participants Standard of care, referral to local available resources.
Sub-group Analyses - Change in Overdose Risk Behaviors and Perceptions (Take Home Naloxone)	11 Participants	30 Participants	4 Participants	6 Participants

SECONDARY outcome

Timeframe: 3 Months

Population: Perception of likelihood of opioid overdose by housing status. "How likely is it that you will experience an opiate overdose in the next year?"

Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.)

Outcome measures

Measure	Intervention (OOPEN+BBCC) n=8 Participants Study intervention, overdose prevention, education, intervention, brief behavioral change counseling, take-home naloxone, referral to local available resources. OOPEN+BBCC: Take-home naloxone is offered as part of a behavioral prevention intervention to reduce the occurrence of future opioid overdose.	Control n=27 Participants Standard of care, referral to local available resources.	Control - Permanent or Stable Housing n=16 Participants Standard of care, referral to local available resources.	Control - Temporary or Unstable Housing or Unhoused. n=13 Participants Standard of care, referral to local available resources.
Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) Extremely likely	0 Participants	1 Participants	0 Participants	0 Participants
Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) Somewhat likely	0 Participants	0 Participants	2 Participants	1 Participants
Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) Not sure	2 Participants	5 Participants	3 Participants	3 Participants
Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) Somewhat unlikely	3 Participants	7 Participants	3 Participants	1 Participants
Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) Extremely unlikely	3 Participants	14 Participants	8 Participants	8 Participants

SECONDARY outcome

Timeframe: 3 Months

Population: Perception of concern about opioid overdose by housing status. "How concerned are you about YOU experiencing an overdose?"

Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.)

Outcome measures

Measure	Intervention (OOPEN+BBCC) n=8 Participants Study intervention, overdose prevention, education, intervention, brief behavioral change counseling, take-home naloxone, referral to local available resources. OOPEN+BBCC: Take-home naloxone is offered as part of a behavioral prevention intervention to reduce the occurrence of future opioid overdose.	Control n=27 Participants Standard of care, referral to local available resources.	Control - Permanent or Stable Housing n=16 Participants Standard of care, referral to local available resources.	Control - Temporary or Unstable Housing or Unhoused. n=13 Participants Standard of care, referral to local available resources.
Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) Extremely concerned	1 Participants	5 Participants	2 Participants	1 Participants
Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) Somewhat concerned	1 Participants	2 Participants	3 Participants	1 Participants
Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) Not sure	1 Participants	1 Participants	0 Participants	0 Participants
Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) Not very concerned	4 Participants	6 Participants	4 Participants	2 Participants
Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) Not concerned at all	1 Participants	13 Participants	7 Participants	9 Participants

SECONDARY outcome

Timeframe: Two years

Population: Health care cost data were not obtained, therefore these analyses could not be conducted.

Total health care costs

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Two years

Population: Data for initiation of buprenorphine and methadone for those not on treatment medications were not obtained, therefore these analyses could not be conducted.

Rate and elapsed time until initiation of buprenorphine or methadone maintenance. (for those not on treatment medications)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Two years

Population: Retention data for buprenorphine and methadone were not obtained, therefore these analyses could not be conducted.

Retention time on buprenorphine or methadone (for those on medications at baseline)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Two years

Population: Specific dates when naloxone was obtained were not collected, therefore these analyses could not be conducted.

Crossover analysis- Comparison group participants who obtain naloxone during the follow up period will be analyzed with those in the intervention arm and compared with those who did not obtain naloxone in the comparison arm to examine differences in overdose rates and elapsed time to overdose.

Outcome measures

Outcome data not reported

Adverse Events

Intervention (OOPEN+BBCC)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 10 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 13 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: calebbg@uw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place