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Project OOPEN: Opioid Overdose Prevention, Education and Intervention (OOPEN)

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ClinicalTrials.gov Identifier: NCT01788306
Recruitment Status : Completed
First Posted : February 11, 2013
Last Update Posted : April 17, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Caleb Banta-Green, University of Washington

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Opioid Overdose Drug: OOPEN+BBCC Phase 4

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 518 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Trial to Prevent Opioid Overdose: E.D. Based Intervention & Take-home Naloxone
Study Start Date : January 2013
Actual Primary Completion Date : October 2018
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Naloxone

Arm Intervention/treatment
Active Comparator: Intervention (OOPEN+BBCC)
Study intervention, overdose prevention, education, intervention, brief behavioral change counseling, take-home naloxone, referral to local available resources.
Drug: OOPEN+BBCC
Take-home naloxone is offered as part of a behavioral prevention intervention to reduce the occurrence of future opioid overdose.

No Intervention: Control
Standard of care, referral to local available resources.



Primary Outcome Measures :
  1. Opioid overdose [ Time Frame: One year ]
    Rates of opioid fatal overdose

  2. Opioid overdose [ Time Frame: One year ]
    Rates of opioid non-fatal overdose

  3. Opioid overdose [ Time Frame: One year ]
    Elapsed time until opioid overdose

  4. Change in overdose risk [ Time Frame: Baseline, 3 months, 6 months, 12 months ]
    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.


Secondary Outcome Measures :
  1. Health care utilization [ Time Frame: Two years ]
    Appropriate health care utilization (e.g. fewer emergency department visits and admissions to inpatient care)

  2. Health care utilization [ Time Frame: Two years ]
    Rate and elapsed time until initiation of buprenorphine or methadone maintenance. (for those not on treatment medications)

  3. Health care utilization [ Time Frame: Two years ]
    Retention time on buprenorphine or methadone (for those on medications at baseline)

  4. Health care costs [ Time Frame: Two years ]
    Total health care costs

  5. Change in HIV risk behaviors [ Time Frame: Baseline, 3 months, 6 months, 12 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.

  6. Change in overdose risk behaviors and perceptions [ Time Frame: Baseline, 3 months, 6 months, 12 months ]

    Change in overdose response including calling 911, rescue breathing, administering naloxone.

    Change in overdose risk perceptions.


  7. Opioid overdose - crossover analysis [ Time Frame: Two years ]
    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.

  8. Opioid overdose - subgroup analyses [ Time Frame: Two years ]
    Sub-group analyses- all primary and secondary outcomes will be examined by homelessness status at baseline.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Meets study definition of elevated risk of future opioid overdose

  • Reason for visit is opioid overdose (regardless of frequency of use), or
  • Use of pharmaceutical opioids not prescribed to the patient 2 or more times in the prior month, or
  • Use of other opioids, alcohol, benzodiazepines or stimulants within two hours of using opioids 2 or more times in the prior month, or
  • Average daily dose of prescribed opioids consumed is greater than10 mg morphine equivalent analgesic dose or higher for 15 or more days in the last 30.
  • Enrolled in opioid substitution program (e.g. methadone or suboxone) and receiving doses.
  • Use of heroin through any route of administration at least 2 times in the last 30 days (or if institutionalized recently, in the most recent month they were not institutionalized) with or without other risks being present.
  • Use of pharmaceutical opioids at least 2 times in the last 30 days (or if institutionalized recently, in the most recent month they were not institutionalized) with other risks being present.
  • Average daily dose of prescribed opioids consumed is 30 mg morphine equivalent analgesic dose or higher without other risks being present.(For adult medicine clinic patients only.)

Exclusion Criteria:

  • Unwilling to allow further access to medical or drug treatment records.
  • Inability to communicate in English.
  • Current active suicidal ideation.
  • Significant cognitive or psychiatric impairment (per judgment of clinical staff)
  • Inability to provide adequate contact information to assist with follow-up.
  • Under age 18 or over age 70 at time of recruitment.
  • Not currently living in Washington State or planning to move from Washington State within the following year.
  • Receiving treatment for sexual assault.
  • Have non-expired take-home naloxone at home, on their person, or in their possessions.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01788306


Locations
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United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Evergreen Treatment Services
Seattle, Washington, United States, 98134
University of Washington Medical Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
National Institute on Drug Abuse (NIDA)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Caleb Banta-Green, Research Scientist, University of Washington
ClinicalTrials.gov Identifier: NCT01788306     History of Changes
Other Study ID Numbers: 43874
1R01DA030351 ( U.S. NIH Grant/Contract )
First Posted: February 11, 2013    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Keywords provided by Caleb Banta-Green, University of Washington:
Elevated risk
opioid overdose
Additional relevant MeSH terms:
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Drug Overdose
Substance-Related Disorders
Chemically-Induced Disorders
Analgesics, Opioid
Naloxone
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists