Clinical Trial: Project OOPEN: Opioid Overdose Prevention, Education and Intervention

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Trial to Prevent Opioid Overdose: E.D. Based Intervention & Take-home Naloxone

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.

Detailed Summary:

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.

Sponsor: University of Washington

Current Primary Outcome:

• Opioid overdose [ Time Frame: One year ]
  Rates of opioid fatal overdose
• Opioid overdose [ Time Frame: One year ]
  Rates of opioid non-fatal overdose
• Opioid overdose [ Time Frame: One year ]
  Elapsed time until opioid overdose
• 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.

Original Primary Outcome:

• Opioid overdose [ Time Frame: One year ]
  Rates of opioid non-fatal and fatal overdose
• 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, use of opioids in an environment that supports continued opioid use.

Current Secondary Outcome:

• Health care utilization [ Time Frame: Two years ]
  Appropriate health care utilization (e.g. fewer emergency department visits and admissions to inpatient care)
• Health care utilization [ Time Frame: Two years ]
  Rate and elapsed time until initiation of buprenorphine or methadone maintenance. (for those not on treatment medications)
• Health care utilization [ Time Frame: Two years ]
  Retention time on buprenorphine or methadone (for those on medications at baseline)
• Health care costs [ Time Frame: Two years ]
  Total health care costs
• 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.
• 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.

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

Original Secondary Outcome:

• Health care utilization [ Time Frame: Two years ]
  Appropriate health care utilization (e.g. fewer emergency department visits and admissions to inpatient care)
• Health care costs [ Time Frame: Two years ]
  Total health care costs
• 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.

Information By: University of Washington

Dates:
Date Received: February 1, 2013
Date Started: January 2013
Date Completion: April 2021
Last Updated: November 1, 2016
Last Verified: November 2016