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Safety and Health Intervention Project (SHIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02152397
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : April 17, 2017
Sponsor:
Information provided by (Responsible Party):
Amy S.B. Bohnert, University of Michigan

Tracking Information
First Submitted Date  ICMJE May 19, 2014
First Posted Date  ICMJE June 2, 2014
Last Update Posted Date April 17, 2017
Actual Study Start Date  ICMJE October 2014
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2014)
  • Overdose risk behavior [ Time Frame: Change over time (3- and 6-month post-baseline) ]
    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 [ Time Frame: Change over time (3- and 6-months post-baseline) ]
    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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Health Intervention Project
Official Title  ICMJE Developing a Prescription Opioid Overdose Prevention Intervention in Addictions Treatment
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Drug Overdose
  • Opioid Related Disorders
Intervention  ICMJE Behavioral: Therapist-led brief intervention (TBI)
Study Arms  ICMJE
  • Active Comparator: Therapist-led brief intervention (TBI)
    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.
    Intervention: Behavioral: Therapist-led brief intervention (TBI)
  • No Intervention: Enhanced usual care
    Participants will receive therapist-led, computer-assisted control sessions with a therapist.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 13, 2016)
139
Original Estimated Enrollment  ICMJE
 (submitted: May 28, 2014)
400
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02152397
Other Study ID Numbers  ICMJE 1R34DA035331-01A1( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amy S.B. Bohnert, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Amy Bohnert, PhD University of Michigan
PRS Account University of Michigan
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP