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Completed

NCT Number: NCT02120612

Increasing Patient Knowledge of the Signs of Opioid Overdose and Naloxone in a Suburban Treatment Program

The purpose of this study is to determine the effect that an educational intervention has on patient knowledge of the signs of opioid overdose and appropriate use of naloxone in a suburban outpatient treatment program.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Linden Oaks

Naperville, Illinois, 60563, United States

About this study

The outpatient Addiction Services program at Linden Oaks will begin implementing an educational program on the signs of opioid overdose and naloxone for all patients who have a diagnosis of opiate dependence in the investigators suburban treatment program. Subjects will be recruited from that population and administered a new, empirically validated scale (i.e. the Opiate Overdose Knowledge Scale; OOKS) both pre- and post-intervention to measure the effect that the educational program has on patient knowledge.

Patients will also be surveyed (i.e. History Survey) about their experiences over the previous 12-months (e.g. exposure to opiate overdoses, access/use of naloxone) prior to treatment; and, this History Survey will then be re-administered by phone, 1-3 months after discharge. The aim is to measure whether education influences patient behavior. Finally, all subjects will be administered an empirically-validated measure to assess subject shame and guilt (i.e. Guilt and Shame Proneness Scale; GASP), and response patterns in their behavior, to evaluate whether shame and guilt predict behavior at follow-up. The investigators will compare to data (i.e. OOKS, GASP, and History Survey) from a historical control group prior to the implementation of the educational program - and, also at 1-3 month follow-up.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult subjects who have been diagnosed with a DSM opioid use disorder by LOH staff.

Exclusion criteria

  • Subjects who are deemed to have moderate to severe cognitive impairment - as assessed by standard psychiatric evaluation from Linden Oaks clinical staff - will be excluded from the study.

Treatment and study plan

Naloxone Education Intervention

Other

The Naloxone Education Intervention is a curriculum that has been adapted from New York State Department of Health's, "Opioid Overdose Prevention" program for non-medical responders.

Primary outcomes

  1. Opiate Overdose Knowledge Scale (OOKS)

    Time frame: 0-3 months

    The Opiate Overdose Knowledge Scale (OOKS) is an empirically-validated scale that measures knowledge of: (1) the risks, warning signs, and life-saving steps to take regarding an opioid overdose; and, (2) the appropriate use of naloxone.

Secondary outcomes

  1. History Survey

    Time frame: 0-3 months

    The History Survey assesses subjects' experiences over the previous 12-months (e.g. exposure to opiate overdoses, access/use of naloxone).

  2. Guilt and Shame Proneness Scale (GASP)

    Time frame: 0-3 months

    The Guilt and Shame Proneness Scale (GASP) is an empirically-validated measure to assess subject shame and guilt and behavioral response patterns.

Sponsors and collaborators

Lead sponsor

Edward Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Apr 23, 2014
Registry last updated
Jul 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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