Safety & Prevention Outcomes Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Drug Overdose Opioid-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

TBI - Cohort 1

Intervention Type BEHAVIORAL

Enhanced usual care - Cohort 1

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

TBI - Cohort 2

Intervention Type BEHAVIORAL

Enhanced usual care - Cohort 2

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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TBI - Cohort 1

Intervention Type BEHAVIORAL

TBI - Cohort 2

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No