Skip to content

Evaluation of a Computerized Opioid Overdose Prevention Program

Development and Validation of a Computerized Opioid Overdose Intervention.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02040077
Enrollment
75
Registered
2014-01-20
Start date
2015-01-31
Completion date
2015-09-30
Last updated
2017-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Computer + Fluency, Computer Only, Treatment as Usual

Keywords

opioid, overdose, OD, opiate, prescription opioids, prescription pain medication, heroin, detoxification, prevention

Brief summary

Unintentional fatal drug overdose (OD) is now the 2nd leading cause of accidental death in the general population. Fatal OD from opioid analgesics specifically has increased over 400% between 1999 and 2008, and nonfatal overdose occurs at a rate 3-7 greater than fatal OD. Unintentional opioid OD is a public health crisis in several societal populations including drug users, patients being treated for chronic pain, elderly individuals, adolescents, and children. Educational interventions have been developed to increase knowledge regarding opioid OD risk factors, symptoms, and appropriate responses, however no randomized controlled evaluations of these interventions have been conducted. Within-subject evaluations report immediate and sustained increases in participant knowledge and behavior change, yet these programs suffer from limitations that may limit their widespread dissemination. Thus, there is an urgent, critical need to develop an opioid OD educational intervention that can be accessed by a broad audience, and produces immediate and sustained gains in knowledge in an easily administered and cost-effective way. This study will develop a web-based, computerized, interactive, opioid OD education training program that will incorporate multi-media learning components and fluency training to produce knowledge gains. This program will be evaluated using a randomized, controlled comparison of the active intervention against two control interventions. Participants will be recruited from a brief inpatient detoxification (n=75), will receive the intervention immediately upon completing the detoxification (post-treatment), and will complete 2 follow-up visits to evaluate sustained knowledge. The primary outcome will be percent change from baseline on a knowledge test that is administered immediately before and after the intervention, and at a 1 and 3-month follow-up visit. Secondary outcomes will include self-reported behavior change and participant acceptance of the intervention. The study hypothesis is that participants who receive the primary intervention will evidence the largest increase in knowledge gain and retention over time, compared to the control groups. The rationale and public health benefit of this research cannot be understated- this project will make available a brief, empirically-supported intervention that can be administered quickly and easily within hundreds of settings (e.g., treatment centers, prisons and jails, needle exchange centers, primary care offices, schools), and to diverse patient populations (e.g., drug users, chronic pain patients, elderly, student, children, parents). These outcomes are expected to have a positive impact because they will provide cheap, easily-administered intervention strategy that will help reduce the current national epidemic of opioid OD, and will expand the use of computerized interventions to address public health issues more broadly.

Interventions

BEHAVIORALComputer + Fluency
BEHAVIORALComputer Only
BEHAVIORALTreatment as Usual

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age (\>18yrs old) * Past yr diagnosis of opioid dependence * Recent completion of opioid detoxification

Exclusion criteria

* Completion of local overdose prevention programs and/or beta-testing of the computerized intervention * Physical limitations that will prevent adequate seeing/hearing of the intervention, or from using computer

Design outcomes

Primary

MeasureTime frameDescription
Knowledge GainBefore the intervention (pre-test) and immediately after the intervention (post-test), an average of 10 minutes.The primary outcome is based on performance in the randomized, controlled trial and is change from baseline on a knowledge test that is administered immediately before and after the intervention. At the time of the study, no validated scales to assess general information regarding overdose in a true/false manner were available. Therefore the study developed a scale for the purpose of measuring knowledge increase. The scale included 51 items, rated as true, false, or I don't know (to discourage random guessing from resulting in accurate responses accidentally). The answers to all items were included as part of the intervention content so it was possible for every answer to be learned. The scale was summed together as a single measure of number correct responses (range 0-51) with no subscales. Higher values indicated more correct responses.

Secondary

MeasureTime frameDescription
Percent Participants Who Would Recommend the Intervention to a Family Member or Friend.Immediately after the intervention (an average of 10 minutes).Participant willingness (yes or no) to recommend the intervention to a family member or friend.

Countries

United States

Participant flow

Pre-assignment details

Although the study expected to enroll and randomize 75 participants, an additional participant was randomized into the study - resulting in a final overall sample of 76 randomized participants.

Participants by arm

ArmCount
Computer + Questions
Will receive computerized intervention and will be required to periodically answer questions embedded within the program correctly to proceed into the next module.
27
Computer Only
Will receive computerized intervention with no embedded questions
24
Pamphlet
Receive a printed version of the same intervention
25
Total76

Baseline characteristics

CharacteristicComputer + QuestionsComputer OnlyPamphletTotal
Age, Continuous40.0 years
STANDARD_DEVIATION 13.1
37.8 years
STANDARD_DEVIATION 10.6
41.9 years
STANDARD_DEVIATION 14.1
39.9 years
STANDARD_DEVIATION 12.6
Region of Enrollment
United States
27 Participants24 Participants25 Participants76 Participants
Sex: Female, Male
Female
12 Participants7 Participants12 Participants31 Participants
Sex: Female, Male
Male
15 Participants17 Participants13 Participants45 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 270 / 240 / 25
other
Total, other adverse events
0 / 270 / 240 / 25
serious
Total, serious adverse events
0 / 270 / 240 / 25

Outcome results

Primary

Knowledge Gain

The primary outcome is based on performance in the randomized, controlled trial and is change from baseline on a knowledge test that is administered immediately before and after the intervention. At the time of the study, no validated scales to assess general information regarding overdose in a true/false manner were available. Therefore the study developed a scale for the purpose of measuring knowledge increase. The scale included 51 items, rated as true, false, or I don't know (to discourage random guessing from resulting in accurate responses accidentally). The answers to all items were included as part of the intervention content so it was possible for every answer to be learned. The scale was summed together as a single measure of number correct responses (range 0-51) with no subscales. Higher values indicated more correct responses.

Time frame: Before the intervention (pre-test) and immediately after the intervention (post-test), an average of 10 minutes.

ArmMeasureGroupValue (MEAN)Dispersion
Computer + MasteryKnowledge GainPre-Test30.6 units on a scaleStandard Deviation 5.75
Computer + MasteryKnowledge GainPost-Test40.7 units on a scaleStandard Deviation 6.22
Computer OnlyKnowledge GainPre-Test30.5 units on a scaleStandard Deviation 5.8
Computer OnlyKnowledge GainPost-Test40.5 units on a scaleStandard Deviation 6.16
PamphletKnowledge GainPre-Test27.56 units on a scaleStandard Deviation 5.94
PamphletKnowledge GainPost-Test36.2 units on a scaleStandard Deviation 10.88
Secondary

Percent Participants Who Would Recommend the Intervention to a Family Member or Friend.

Participant willingness (yes or no) to recommend the intervention to a family member or friend.

Time frame: Immediately after the intervention (an average of 10 minutes).

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Computer + MasteryPercent Participants Who Would Recommend the Intervention to a Family Member or Friend.27 Participants
Computer OnlyPercent Participants Who Would Recommend the Intervention to a Family Member or Friend.24 Participants
PamphletPercent Participants Who Would Recommend the Intervention to a Family Member or Friend.25 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026