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Completed

NCT Number: NCT01894087

Safety & Prevention Outcomes Study

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.

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Key information

Conditions

Drug Overdose Chemically-Induced Disorders Drug Misuse Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Prescription Drug Misuse Substance-Related Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Health System Emergency Department

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TBI - Cohort 1

Behavioral

TBI - Cohort 2

Behavioral

Primary outcomes

  1. Overdose Risk Behavior

    Time frame: 6 months post-baseline

    This scale is a total sum of 9 items assessing participant's self-report of engaging in behavior that increases risk for overdose. Higher scores indicate greater risk for overdose. The range for this measure is 0 to 28 in one assessment. Results reported here as group means are for the change in sum score between baseline and follow-up, which had a possible range of -28 to 28, with lower values indicating greater decreases in overdose risk behavior.

  2. Overdose Knowledge

    Time frame: 6 months post-baseline

    Overdose symptom knowledge was assessed using an inventory of 5 true symptoms and 2 false symptoms of overdose, and the total score created as the sum of correct answers, with a range of 0 to 7. Due to the skewed distribution, this total score was standardized by subtracting the observed responses from the overall sample mean, and then dividing by the standard deviation. This resulted in a range of -5.4 to 2.6 in this sample at the 6 month follow-up, with higher numbers indicating greater overdose symptom knowledge. Also reported here are change scores generated by subtracting the standardized sum score at 6 months from the baseline standardized sum score, which had a range of -3.0 to 6.4 in this sample. Thus, higher numbers in this "change" variable indicated greater improvements in overdose symptom knowledge. Negative numbers would represent a decrease in symptom knowledge.

  3. Behavioral Intentions

    Time frame: 6 months post-baseline

    Behavioral intentions were assessed with three items that measured participant's intention to use overdose risk reduction strategies. The three strategies were (1) using opioids as prescribed, (2) reducing or avoiding use of alcohol, drugs, or non-prescribed medications, and (3) avoiding combining substances. Each item was assessed on a scale of 1 to 10, with higher numbers indicating greater intention to avoid overdose risk.

Secondary outcomes

  1. Substance Use - Current Opioid Misuse Measure

    Time frame: 6 months post-baseline

    This measure contained 8 items from the Current Opioid Misuse Measure. Items were assessed on a scale of "never (0)," "rarely (1)," "sometimes (3)," "often (4)," and "very often (5)." A sum score took a range of 0 to 40, with higher numbers indicating more non-medical opioid use. For group means reported here, change scores were calculated by subtracting the baseline level of this measure from the level at 6 months follow-up. This change score has a possible range of -40 to 40, with lower values indicating greater decreases in non-medical opioid use.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

A Brief Prescription Opioid Overdose Intervention in an Emergency Department

Acronym: SPOS

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 9, 2013
Registry last updated
Jan 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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