Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA030351 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This prospective, randomized emergency department trial will study the effectiveness of an intervention that combines opioid overdose prevention, education and intervention that includes take home naloxone with brief behavioral change counseling. The study will recruit both heroin users (n=500) and pharmaceutical opioid users at elevated risk for overdose (n=500). Outcomes of interest include subsequent opioid overdoses and overdose risk behaviors.
Primary Aims
The primary aims are to test whether those who receive the intervention compared to standard care have: 1) Lower rates of opioid non-fatal and fatal overdose; 2) Reduce drug use, inappropriate medication use, and other overdose risk behaviors.
Secondary Aims
The secondary aims are to test whether those who receive the intervention compared to standard care have: 3) More appropriate health care utilization (e.g. fewer emergency department visits and admissions to inpatient care); 4) Lower total health care costs; 5) Determine the prevalence of HIV risk behaviors among heroin and pharmaceutical opioid users at risk for overdose and whether the intervention impacts these behaviors.
Fatal overdoses involving pharmaceutical opioids have increased dramatically over the past decade, surpassing those related to heroin, and are the leading cause of drug overdose in much of the U.S. In Seattle-King County, 75% of drug overdoses involved pharmaceutical opioids and/or heroin in 2009. Opioid overdoses, heroin and pharmaceutical, are preventable and reversible. Research indicates that drug users and their partners can be successfully trained to recognize and reverse overdoses with naloxone (an opioid antagonist medicine or "antidote").
Despite active heroin overdose prevention, education and intervention programs with naloxone (OOPEN) in 15 states with thousands of overdose reversals and no serious adverse events, rigorous studies of these programs on rates of subsequent heroin overdoses have not been conducted. No OOPEN programs or studies have yet been implemented for pharmaceutical opioid users at elevated risk for overdose. The Emergency Department (ED) setting holds great promise for identifying and recruiting those at elevated risk of both heroin and pharmaceutical opioid overdose: 1) the ED study site for this proposal provides most services to those needing care for acute opioid related medical problems in Seattle, and 2) patients' need for urgent medical attention may heighten their concern about potential harms from opioids.
Unique to this setting is the potential to identify high risk pharmaceutical opioid users, a population that is difficult to locate and engage. ED interventions using brief behavior change counseling (BBCC) have been shown to significantly improve health behaviors such as alcohol use and injury, to increase entry into drug treatment as well as to reduce costs. Evidence is promising, but limited, regarding the impact of BBCC on opioid related risk behaviors.
This prospective, randomized ED trial will study the effectiveness of an intervention that combines OOPEN with BBCC for both heroin users (n=500) and pharmaceutical opioid users at elevated risk for overdose (n=500). The primary outcome is subsequent opioid overdoses, ascertained by follow up interviews conducted at 3, 6 and 12 months as well as via administrative records for up to 24 months (i.e. medical records, ambulance responses, and death certificates).
Primary Aims
The primary aims are to test whether those who receive the intervention compared to standard care have: 1) Lower rates of opioid non-fatal and fatal overdose; 2) Reduce drug use, inappropriate medication use, and other overdose risk behaviors.
Secondary Aims
The secondary aims are to test whether those who receive the intervention compared to standard care have: 3) More appropriate health care utilization (e.g. fewer emergency department visits and admissions to inpatient care); 4) Lower total health care costs; 5) Determine the prevalence of HIV risk behaviors among heroin and pharmaceutical opioid users at risk for overdose and whether the intervention impacts these behaviors.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention (OOPEN+BBCC) | Active Comparator | Study intervention, overdose prevention, education, intervention, brief behavioral change counseling, take-home naloxone, referral to local available resources. |
|
| Control | No Intervention | Standard of care, referral to local available resources. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OOPEN+BBCC | Drug | Take-home naloxone is offered as part of a behavioral prevention intervention to reduce the occurrence of future opioid overdose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Fatal Opioid Overdose | Rate of fatal opioid overdose | One year |
| Rate of Non-fatal Opioid Overdose | Rate of non-fatal opioid overdose | One year |
| Elapsed Time Until Opioid Overdose | Elapsed time until opioid overdose | Up to1064 days |
| Change in Overdose Risk (Change in Opioid 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.) | 3 months |
| Change in Overdose Risk (Change in Opioid Use - Prescription-Type Opioids) | 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.) | 3 months |
| Change in Overdose Risk (Using Alone When Taking Opioids) | 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.) |
| Measure | Description | Time Frame |
|---|---|---|
| Health Care Utilization (ED and Inpatient Admissions) | Appropriate health care utilization (e.g. fewer emergency department visits and admissions to inpatient care) | One year (annual rate) |
| Change in HIV Risk Behaviors (Condom Use) |
Not provided
Inclusion Criteria:
Meets study definition of elevated risk of future opioid overdose
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harborview Medical Center | Seattle | Washington | 98104 | United States | ||
| Evergreen Treatment Services |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29436397 | Derived | Banta-Green CJ, Coffin PO, Merrill JO, Sears JM, Dunn C, Floyd AS, Whiteside LK, Yanez ND, Donovan DM. Impacts of an opioid overdose prevention intervention delivered subsequent to acute care. Inj Prev. 2019 Jun;25(3):191-198. doi: 10.1136/injuryprev-2017-042676. Epub 2018 Feb 7. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Control | Standard of care, referral to local available resources. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Fatal Opioid Overdose | Rate of fatal opioid overdose | Number of participants experiencing fatal opioid overdose. | Posted | Count of Participants | Participants | One year |
|
Three years.
In this study, potential adverse events that may be related to the study would be an increase in emotional distress in relation to discussion of past or current drug use behaviors or side effects of naloxone.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Caleb Banta-Green | University of Washington | 206-543-0937 | calebbg@uw.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 22, 2014 | Nov 12, 2020 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000083682 | Opiate Overdose |
| ID | Term |
|---|---|
| D062787 | Drug Overdose |
| D063487 | Prescription Drug Misuse |
| D000076064 | Drug Misuse |
| D019966 | Substance-Related Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 3 months |
| Change in Overdose Risk (Use of Sedatives When Taking Opioids) | 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.) | 3 months |
| Change in Overdose Risk (Use of Alcohol When Taking Opioids) | 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.) | 3 months |
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.)
| 3 months |
| Change in HIV Risk Behaviors (Shared Syringes) | 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.) | 3 months |
| Change in Overdose Risk Behaviors and Perceptions (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.) | 3 Months |
| Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) | Change in overdose response including naloxone availability and change in overdose risk perceptions. (Data table includes proportions at 3 month follow-up.) | 3 Months |
| Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) | Change in overdose response including naloxone availability and change in overdose risk perceptions. (Data table includes proportions at 3 month follow-up.) | 3 Months |
| Subgroup Analyses - Change in HIV Risk Behaviors (Condom Use) | Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.) | 3 months |
| Subgroup Analyses - Change in HIV Risk Behaviors (Shared Syringes) | Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.) | 3 months |
| Sub-group Analyses - Change in Overdose Risk (Change in Opioid 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.) | 3 months |
| Sub-group Analyses - Change in Overdose Risk (Change in Opioid 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.) | 3 months |
| Sub-group Analyses - Change in Overdose Risk (Using Alone When Taking Opioids) | Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes means at 3 month follow-up.) | 3 months |
| Subgroup Analyses- Change in Overdose Risk (Use of Sedatives When Taking 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.) | 3 months |
| Subgroup Analyses- Change in Overdose Risk (Use of Alcohol When Taking 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.) | 3 months |
| Sub-group Analyses - Change in Overdose Risk Behaviors and Perceptions (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.) | 3 Months |
| Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Likelihood of 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.) | 3 Months |
| Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Concerned About 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.) | 3 Months |
| Health Care Costs | Total health care costs | Two years |
| Health Care Utilization | Rate and elapsed time until initiation of buprenorphine or methadone maintenance. (for those not on treatment medications) | Two years |
| Health Care Utilization | Retention time on buprenorphine or methadone (for those on medications at baseline) | Two years |
| Opioid Overdose - Crossover Analysis | 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. | Two years |
| Seattle |
| Washington |
| 98134 |
| United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| Control |
Standard of care, referral to local available resources. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Opioid overdose past 3 months | Count of Participants | Participants |
|
|
|
| Primary | Rate of Non-fatal Opioid Overdose | Rate of non-fatal opioid overdose | Number of participants experiencing non-fatal opioid overdose. | Posted | Count of Participants | Participants | One year |
|
|
|
| Primary | Elapsed Time Until Opioid Overdose | Elapsed time until opioid overdose | Mean days to first overdose event | Posted | Mean | Full Range | days | Up to1064 days |
|
|
|
| Primary | Change in Overdose Risk (Change in Opioid 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.) | Participants reporting change in heroin use: "Compared to the last time you spoke with research staff 3 months ago, do you use heroin..." | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Primary | Change in Overdose Risk (Change in Opioid Use - Prescription-Type Opioids) | 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.) | 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..." | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Primary | Change in Overdose Risk (Using Alone When Taking Opioids) | 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.) | 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?" | Posted | Mean | Standard Deviation | days in the past 30 | 3 months |
|
|
|
| Primary | Change in Overdose Risk (Use of Sedatives When Taking Opioids) | 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.) | Use of sedatives when taking opioids, "When you use opioids, how often do you use sedatives or downers within 2 hours before or after?" . | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Primary | Change in Overdose Risk (Use of Alcohol When Taking Opioids) | 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.) | Use of alcohol when taking opioids, "When you use opioids, how often do drink alcohol with 2 hours before or after?" | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Health Care Utilization (ED and Inpatient Admissions) | Appropriate health care utilization (e.g. fewer emergency department visits and admissions to inpatient care) | Annual mean number per person | Posted | Mean | 95% Confidence Interval | annual visits | One year (annual rate) |
|
|
|
| Secondary | Change in HIV Risk Behaviors (Condom Use) | 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.) | Frequency of condom use in the past 3 months, "In the past three months, how often did you use condoms when you had sex?" | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Change in HIV Risk Behaviors (Shared Syringes) | 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.) | Number of participants who shared syringes or injection supplies, "In the past three months, have you shared needles or works?" | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Change in Overdose Risk Behaviors and Perceptions (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.) | Number of people with naloxone in the past 3 months, "At any time in the past 3 months did you have take-home naloxone?" | Posted | Count of Participants | Participants | 3 Months |
|
|
|
| Secondary | Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) | Change in overdose response including naloxone availability and change in overdose risk perceptions. (Data table includes proportions at 3 month follow-up.) | Perception of likelihood of opioid overdose, "How likely is it that you will experience an opiate overdose in the next year?" | Posted | Count of Participants | Participants | 3 Months |
|
|
|
| Secondary | Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) | Change in overdose response including naloxone availability and change in overdose risk perceptions. (Data table includes proportions at 3 month follow-up.) | Perception of concern about opioid overdose, "How concerned are you about YOU experiencing an overdose?" | Posted | Count of Participants | Participants | 3 Months |
|
|
|
| Secondary | Subgroup Analyses - Change in HIV Risk Behaviors (Condom Use) | Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.) | 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?" | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Subgroup Analyses - Change in HIV Risk Behaviors (Shared Syringes) | Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.) | Number of participants who shared syringes or injection supplies by housing status. "In the past three months, have you shared needles or works?" | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Sub-group Analyses - Change in Overdose Risk (Change in Opioid 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.) | 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..." | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Sub-group Analyses - Change in Overdose Risk (Change in Opioid 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.) | 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..." | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Sub-group Analyses - Change in Overdose Risk (Using Alone When Taking Opioids) | Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes means at 3 month follow-up.) | 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?" | Posted | Mean | Standard Deviation | days in the past 30 | 3 months |
|
|
|
| Secondary | Subgroup Analyses- Change in Overdose Risk (Use of Sedatives When Taking 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.) | 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?" | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Subgroup Analyses- Change in Overdose Risk (Use of Alcohol When Taking 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.) | Use of alcohol when taking opioids by housing status "When you use opioids, how often do drink alcohol with 2 hours before or after?" | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Sub-group Analyses - Change in Overdose Risk Behaviors and Perceptions (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.) | 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?" | Posted | Count of Participants | Participants | 3 Months |
|
|
|
| Secondary | Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Likelihood of 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.) | Perception of likelihood of opioid overdose by housing status. "How likely is it that you will experience an opiate overdose in the next year?" | Posted | Count of Participants | Participants | 3 Months |
|
|
|
| Secondary | Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Concerned About 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.) | Perception of concern about opioid overdose by housing status. "How concerned are you about YOU experiencing an overdose?" | Posted | Count of Participants | Participants | 3 Months |
|
|
|
| Secondary | Health Care Costs | Total health care costs | Health care cost data were not obtained, therefore these analyses could not be conducted. | Posted | Two years |
|
|
| Secondary | Health Care Utilization | Rate and elapsed time until initiation of buprenorphine or methadone maintenance. (for those not on treatment medications) | Data for initiation of buprenorphine and methadone for those not on treatment medications were not obtained, therefore these analyses could not be conducted. | Posted | Two years |
|
|
| Secondary | Health Care Utilization | Retention time on buprenorphine or methadone (for those on medications at baseline) | Retention data for buprenorphine and methadone were not obtained, therefore these analyses could not be conducted. | Posted | Two years |
|
|
| Secondary | Opioid Overdose - Crossover Analysis | 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. | Specific dates when naloxone was obtained were not collected, therefore these analyses could not be conducted. | Posted | Two years |
|
|
| 10 |
| 115 |
| 0 |
| 115 |
| 0 |
| 115 |
| EG001 | Control | Standard of care, referral to local available resources. | 13 | 126 | 0 | 126 | 0 | 126 |
Not provided
Not provided
| D064419 |
| Chemically-Induced Disorders |
| D009293 | Opioid-Related Disorders |
| D000079524 | Narcotic-Related Disorders |
| D001523 | Mental Disorders |
| Same Amount |
|
| Don't Know |
|
| N/A (was not using previously) |
|
| Same Amount |
|
| Don't know Don't Know |
|
| N/A (was not using previously) |
|
| Follow-up |
|
|
| Baseline: Sometimes |
|
|
| Baseline: Never |
|
|
| Follow-up: Always |
|
|
| Follow-up: Sometimes |
|
|
| Follow-up: Never |
|
|
| Baseline: Sometimes |
|
|
| Baseline: Never |
|
|
| Follow-up: Always |
|
|
| Follow-up: Sometimes |
|
|
| Follow-up: Never |
|
|
| Most of the time |
|
| Some of the time |
|
| None of the time |
|
| Not applicable/No sex past 3 months |
|
| Follow-up |
|
|
| Follow-up |
|
|
| Not sure |
|
| Extreme/somewhat unlikely |
|
| Follow-up |
|
|
| Not sure |
|
| Not very/at all concerned |
|
| Follow-up |
|
|
| Most of the time |
|
| Some of the time |
|
| None of the time |
|
| Not applicable/No sex past 3 months |
|
| Less |
|
| Same Amount |
|
| Don't Know |
|
| N/A (was not using previously) |
|
| Less |
|
| Same Amount |
|
| Don't Know |
|
| N/A (was not using previously) |
|
| Sometimes |
|
| Never |
|
| Sometimes |
|
| Never |
|
| Somewhat likely |
|
| Not sure |
|
| Somewhat unlikely |
|
| Extremely unlikely |
|
| Somewhat concerned |
|
| Not sure |
|
| Not very concerned |
|
| Not concerned at all |
|