Safety & Prevention Outcomes Study (SPOS)

• ClinicalTrials.gov Identifier: NCT01894087
• Recruitment Status: Completed
• First Posted: July 9, 2013
• Results First Posted: January 19, 2018
• Last Update Posted: January 19, 2018
• Sponsor: University of Michigan
• Collaborator: Centers for Disease Control and Prevention
• Information provided by (Responsible Party): Amy S.B. Bohnert, University of Michigan

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Drug Overdose; Opioid-Related Disorders	Behavioral: TBI - Cohort 1; Behavioral: TBI - Cohort 2	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 204 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Brief Prescription Opioid Overdose Intervention in an Emergency Department
• Study Start Date: April 2013
• Actual Primary Completion Date: January 2015
• Actual Study Completion Date: January 2015

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Michigan

University of Michigan Health System Emergency Department

Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

University of Michigan

Centers for Disease Control and Prevention

Investigators

• Principal Investigator: Amy Bohnert, Ph.D.; University of Michigan

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Amy S.B. Bohnert, Assistant Professor, University of Michigan
• ClinicalTrials.gov Identifier: NCT01894087
• Other Study ID Numbers: R49CE002099 ( U.S. NIH Grant/Contract )
• First Posted: July 9, 2013
• Results First Posted: January 19, 2018
• Last Update Posted: January 19, 2018
• Last Verified: May 2017

Additional relevant MeSH terms:

Opioid-Related Disorders; Drug Overdose; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders