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

NCT ID: NCT02120612

Last Updated: 2020-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2020-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Opioid Dependence Opioid Use Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Historical Control Group

Historical Control Group will be assessed for knowledge prior to the implementation of the educational program.

No interventions assigned to this group

Naloxone Education Intervention Group

Group to begin receiving the Naloxone Education Intervention on the signs of opioid overdose and appropriate use of naloxone.

Naloxone Education Intervention

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Naloxone Education Intervention

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Edward Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David C Lott, M.D.

Role: PRINCIPAL_INVESTIGATOR

Linden Oaks Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Linden Oaks

Naperville, Illinois, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LOH32414

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Nasal Naloxone for Narcotic Overdose
NCT01912573 UNKNOWN PHASE4