Safety & Prevention Outcomes Study (SPOS)

This study is currently recruiting participants.
Verified January 2014 by University of Michigan
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Amy S.B. Bohnert, University of Michigan
ClinicalTrials.gov Identifier:
NCT01894087
First received: July 2, 2013
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

Unintentional poisoning is a developing public health problem in the U.S. Unintentional poisoning (or "overdose") deaths increased 157% among adults between 1999 and 2008. There were ~700,000 emergency department (ED) visits due to overdoses in 2007. Medication-related overdoses, particularly prescription opioid overdoses, have accounted for much of this increase. There have been parallel increases in sales of opioids (with a 6 fold increase between 1997 and 2007), as well as both medical and non-medical use of prescription opioids. Prescription opioids are now among the most common of drugs used non-medically in the U.S.

The specific aims of this project are to: 1) Develop an ED-based tailored brief prescription opioid overdose prevention intervention. We will examine therapeutic alliance, perceived satisfaction, and perceived utility of the intervention; 2) Examine intervention effects on precursors of overdose risk behavioral change immediately post-intervention. We will compare intervention and control participants on knowledge, self-efficacy, readiness to change, and behavioral intentions regarding overdose risk behavior; and 3) Examine intervention effects on overdose risk behaviors six months post-intervention. We will compare intervention and control participants on: 1) use of high dose/quantity of opioids; 2) using opioids in combinations with certain psychoactive substances (i.e., alcohol, heroin, cocaine, and sedatives); and, 3) route of administration.


Condition Intervention
Drug Overdose
Opioid-Related Disorders
Behavioral: TBI - Cohort 1
Behavioral: TBI - Cohort 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Brief Prescription Opioid Overdose Intervention in an Emergency Department

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Overdose risk behavior [ Time Frame: 6 months post-baseline ] [ Designated as safety issue: No ]
  • Overdose knowledge [ Time Frame: 6 months post-baseline ] [ Designated as safety issue: No ]
  • Behavioral intentions [ Time Frame: 6 months post-baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Substance use [ Time Frame: 6 months post-baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: April 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Therapist-led brief intervention (TBI) - Cohort 1
Participants will receive a therapist-led, computer-assisted intervention session with a master's level therapist. The interventions are designed to address extramedical prescription opioid use and overdose risk behaviors. This includes a review of the participants' strengths, values, and goals; feedback regarding their opioid use and overdose risk behaviors; developing a discrepancy between their opioid and other drug use and ability to meet goals and values; and the formulation of a "change plan" for each participant.
Behavioral: TBI - Cohort 1
No Intervention: Enhanced usual care - Cohort 1
Active Comparator: Therapist-led brief intervention (TBI) - Cohort 2
Participants will receive a therapist-led, computer-assisted intervention session with a master's level therapist. The interventions are designed to address extramedical prescription opioid use and overdose risk behaviors. This includes a review of the participants' strengths, values, and goals; feedback regarding their opioid use and overdose risk behaviors; developing a discrepancy between their opioid and other drug use and ability to meet goals and values; and the formulation of a "change plan" for each participant.
Behavioral: TBI - Cohort 2
No Intervention: Enhanced usual care - Cohort 2

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients 18-60 presenting to the ED for medical care
  • ability to provide informed consent
  • Additional criteria for intervention: past extramedical opioid use

Exclusion Criteria:

  • patients who do not understand English
  • prisoners
  • patients classified by medical staff as a "Level 1" trauma (e.g., in need of immediate lifesaving procedures)
  • patients deemed unable to provide informed consent
  • patients treated in the ED for suicide attempt or sexual assault
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01894087

Contacts
Contact: Anna Eisenberg, MPH 734-615-4171 eanna@med.umich.edu

Locations
United States, Michigan
University of Michigan Health System Emergency Department Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Anna Eisenberg, MPH    734-615-4171    eanna@med.umich.edu   
Principal Investigator: Amy Bohnert, Ph.D.         
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Amy Bohnert, Ph.D. University of Michigan
  More Information

No publications provided

Responsible Party: Amy S.B. Bohnert, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01894087     History of Changes
Other Study ID Numbers: R49 CE002099
Study First Received: July 2, 2013
Last Updated: January 28, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Opioid-Related Disorders
Overdose
Substance-Related Disorders
Mental Disorders
Poisoning
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants

ClinicalTrials.gov processed this record on April 15, 2014