Safety and Health Intervention Project (SHIP)

University of Michigan

Status: Completed

Conditions: Opioid Related Disorders; Drug Overdose

Treatments: Behavioral: Therapist-led brief intervention (TBI)

Study type: Interventional

Funder types: Other

Identifiers

NCT02152397

1R34DA035331-01A1

Details and patient eligibility

About

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.

Enrollment: 139 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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139 participants in 2 patient groups

Therapist-led brief intervention (TBI)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Therapist-led brief intervention (TBI)

Enhanced usual care

No Intervention group

Description:

Participants will receive therapist-led, computer-assisted control sessions with a therapist.