Overview

This trial is active, not recruiting.

Conditions drug overdose, opioid related disorders
Treatment therapist-led brief intervention (tbi)
Sponsor University of Michigan
Start date October 2014
End date February 2017
Trial size 139 participants
Trial identifier NCT02152397, 1R34DA035331-01A1

Summary

Use of opioid medications for treatment of pain has increased greatly in the U.S., with the average quantity of prescribed opioids increasing 700% in a decade, from ~100 morphine milligram equivalents (MME) per person to ~700 MME per person from 1997 to 2007. There have been concurrent increases in opioid-related adverse outcomes, such as extramedical use, opioid use disorders, and overdose. As a result, there were more unintentional poisoning deaths than deaths due to motor vehicle crashes among adults in 2010 (32,723 vs. 32,640). Additionally, the number of Americans seeking treatment for opioid use disorders has increased; in SAMHSA's Treatment Episode Data Set, prescription opioids were the primary substance of abuse for 142,782 individuals in 2009, compared to 22,637 in 1999, a 530% increase.

The specific aims of this project are to: (1) Refine a motivational enhancement prevention intervention for prescription opioid overdose risk reduction and improved witnessed overdose response for at-risk patients in addictions treatment; (2) Conduct a pilot randomized controlled trial comparing the prescription opioid overdose prevention intervention to a supportive educational control condition for patients in addictions treatment in order to: (a) obtain information about the feasibility of randomized controlled procedures; and (b) determine the distribution and variability of the primary (overdose risk behaviors) and mediating/secondary (witnessed overdose response, self-efficacy to reduce overdose risk, knowledge of overdose risk factors and symptom recognition) outcomes; and (3) Determine the distribution and variability in changes in HIV risk behaviors (e.g., reductions in injection of prescription opioids) over follow-up.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
Participants will receive therapist-led, computer-assisted intervention sessions with a 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.
therapist-led brief intervention (tbi)
(No Intervention)
Participants will receive therapist-led, computer-assisted control sessions with a therapist.

Primary Outcomes

Measure
Overdose risk behavior
time frame: Change over time (3- and 6-month post-baseline)
HIV risk behavor
time frame: Change over time (3- and 6-months post-baseline)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients 18 and older in treatment at CPI - able to provide informed consent. Exclusion Criteria: - acute suicidality - psychiatric condition that precludes participation in the intervention - inability to speak and understand English - inability to give informed, voluntary, written consent for any reason

Additional Information

Official title Developing a Prescription Opioid Overdose Prevention Intervention in Addictions Treatment
Principal investigator Amy Bohnert, PhD
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by University of Michigan.