Safety & Prevention Outcomes Study

NCT01894087 | Completed Results

• 1 other identifier: R49CE002099
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Drug Overdose; Opioid-Related Disorders

Outcome Measures

Primary Outcomes (3)

• Overdose Risk Behavior

  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.

  6 months post-baseline

• Overdose Knowledge

  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.

  6 months post-baseline

• Behavioral Intentions

  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.

  6 months post-baseline

Secondary Outcomes (1)

• Substance Use - Current Opioid Misuse Measure

  6 months post-baseline

Study Arms (4)

Therapist-led brief intervention (TBI) - Cohort 1

ACTIVE COMPARATOR

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

Enhanced usual care - Cohort 1

NO INTERVENTION

Therapist-led brief intervention (TBI) - Cohort 2

ACTIVE COMPARATOR

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

Enhanced usual care - Cohort 2

NO INTERVENTION

Interventions

TBI - Cohort 1 BEHAVIORAL

Therapist-led brief intervention (TBI) - Cohort 1

TBI - Cohort 2 BEHAVIORAL

Therapist-led brief intervention (TBI) - Cohort 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

University of Michigan Health System Emergency Department

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Bohnert AS, Bonar EE, Cunningham R, Greenwald MK, Thomas L, Chermack S, Blow FC, Walton M. A pilot randomized clinical trial of an intervention to reduce overdose risk behaviors among emergency department patients at risk for prescription opioid overdose. Drug Alcohol Depend. 2016 Jun 1;163:40-7. doi: 10.1016/j.drugalcdep.2016.03.018. Epub 2016 Mar 26.

  PMID: 27062245 DERIVED

MeSH Terms

Conditions

Drug Overdose; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Narcotic-Related Disorders

Results Point of Contact

• Title: Amy Bohnert
• Organization: University of Michigan

amybohne@med.umich.edu

734-845-3638

Study Officials

• Amy Bohnert, Ph.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 2, 2013
• First Posted: July 9, 2013
• Study Start: April 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: January 19, 2018
• Results First Posted: January 19, 2018

Record last verified: 2017-05

Locations

US (1)