NCT02120612

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 23, 2014

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

July 23, 2020

Status Verified

July 1, 2020

Enrollment Period

6.3 years

First QC Date

April 21, 2014

Last Update Submit

July 21, 2020

Conditions

Keywords

Opioid DependenceAddictionNaloxoneNaloxone EducationOpiate Overdose Knowledge ScaleOOKS

Outcome Measures

Primary Outcomes (1)

  • Opiate Overdose Knowledge Scale (OOKS)

    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.

    0-3 months

Secondary Outcomes (2)

  • History Survey

    0-3 months

  • Guilt and Shame Proneness Scale (GASP)

    0-3 months

Study Arms (2)

Historical Control Group

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

Naloxone Education Intervention Group

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

Other: Naloxone Education Intervention

Interventions

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.

Naloxone Education Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult subjects who have been diagnosed with a DSM opioid use disorder enrolled in an outpatient treatment program for the substance use disorder.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linden Oaks

Naperville, Illinois, 60563, United States

Location

MeSH Terms

Conditions

Opioid-Related DisordersBehavior, Addictive

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersCompulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • David C Lott, M.D.

    Linden Oaks Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2014

First Posted

April 23, 2014

Study Start

April 1, 2014

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

July 23, 2020

Record last verified: 2020-07

Locations