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Safety and Health Intervention Project (SHIP)

Primary Purpose

Drug Overdose, Opioid Related Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Therapist-led brief intervention (TBI)
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Drug Overdose

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Community Programs, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Therapist-led brief intervention (TBI)

Enhanced usual care

Arm 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.

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

Outcomes

Primary Outcome Measures

Overdose risk behavior
Overdose risk behavior will be measured for change over time using the Current Opioid Misuse Measure (COMM), Overdose Experience, Self and Witnessed (OESW), Overdose Risk Behavior (ORB) and Timeline Follow-Back (TLFB). The COMM is an 8 item scale assessing prescription pain medication use in the past months. It has a good test-retest reliability and an α=.93 in our prior studies. The OESW is an 11 item scale assessing experiences with overdoses in the past months (self and witnessed) which are related to drug use and psychosocial characteristics. The ORB is a 27 item scale assessing prescription opioid use, specific to the dose and type of opioid used, combination with other substances, route and if they use alone. The TLFB is a semi-structured interview assessing alcohol and drug use. This instrument has test-retest reliability >.86. All of these measures have been validated.
HIV risk behavor
HIV risk behavior will be measured for change over time using the HIV Risk Behavior Scale (HRBS), HIV testing (HT), Sexual Behaviors (SB) and HIV Risk Questionnaire - Timeline Follow-Back (HRQ-TLFB). The HRBS is a 6 item scale assessing individual HIV risk in regard to drug use. It is derived from an 11 item scale assessing both drug and sexual HIV risk behaviors, and has test-retest reliability >.85. The HT is a 4 item scale assessing testing history and knowledge of own HIV status. The SB is a 30 item scale assessing sexual risk behavior over the past months to assess for HIV risk. The HRQ-TLFB is a semi-structure interview measuring sex and drug HIV risk behavior. It has strong psychometric properties among those with substance use disorders (SUD).

Secondary Outcome Measures

Full Information

First Posted
May 19, 2014
Last Updated
April 14, 2017
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT02152397
Brief Title
Safety and Health Intervention Project
Acronym
SHIP
Official Title
Developing a Prescription Opioid Overdose Prevention Intervention in Addictions Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Overdose, Opioid Related Disorders

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapist-led brief intervention (TBI)
Arm Type
Active Comparator
Arm 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.
Arm Title
Enhanced usual care
Arm Type
No Intervention
Arm Description
Participants will receive therapist-led, computer-assisted control sessions with a therapist.
Intervention Type
Behavioral
Intervention Name(s)
Therapist-led brief intervention (TBI)
Primary Outcome Measure Information:
Title
Overdose risk behavior
Description
Overdose risk behavior will be measured for change over time using the Current Opioid Misuse Measure (COMM), Overdose Experience, Self and Witnessed (OESW), Overdose Risk Behavior (ORB) and Timeline Follow-Back (TLFB). The COMM is an 8 item scale assessing prescription pain medication use in the past months. It has a good test-retest reliability and an α=.93 in our prior studies. The OESW is an 11 item scale assessing experiences with overdoses in the past months (self and witnessed) which are related to drug use and psychosocial characteristics. The ORB is a 27 item scale assessing prescription opioid use, specific to the dose and type of opioid used, combination with other substances, route and if they use alone. The TLFB is a semi-structured interview assessing alcohol and drug use. This instrument has test-retest reliability >.86. All of these measures have been validated.
Time Frame
Change over time (3- and 6-month post-baseline)
Title
HIV risk behavor
Description
HIV risk behavior will be measured for change over time using the HIV Risk Behavior Scale (HRBS), HIV testing (HT), Sexual Behaviors (SB) and HIV Risk Questionnaire - Timeline Follow-Back (HRQ-TLFB). The HRBS is a 6 item scale assessing individual HIV risk in regard to drug use. It is derived from an 11 item scale assessing both drug and sexual HIV risk behaviors, and has test-retest reliability >.85. The HT is a 4 item scale assessing testing history and knowledge of own HIV status. The SB is a 30 item scale assessing sexual risk behavior over the past months to assess for HIV risk. The HRQ-TLFB is a semi-structure interview measuring sex and drug HIV risk behavior. It has strong psychometric properties among those with substance use disorders (SUD).
Time Frame
Change over time (3- and 6-months post-baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Bohnert, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community Programs, Inc.
City
Waterford
State/Province
Michigan
ZIP/Postal Code
48327
Country
United States

12. IPD Sharing Statement

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Safety and Health Intervention Project

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