Opioid Use
Conditions
Keywords
opioid misuse
Brief summary
The purpose of the study is to develop and test innovative interventions to prevent the development of opioid misuse and opioid use disorders among older adolescents and young adults (AYA; ages 16-30) who use opioids, which will be initiated from a health care visit in the emergency department and extended post discharge via a telehealth approach. This study will have significant impact by identifying optimal, cost-effective opioid prevention strategies to sustain outcomes among AYAs.
Interventions
BEHAVIORALBrief intervention (BI)
A remote brief intervention delivered by health coaches that uses Motivational Interviewing to address opioid misuse and risk factors. Remote health coaches use a web-based clinician support guide to maintain fidelity, while tailoring the session to unique participant factors.
BEHAVIORALPortal
Remote health coaches will push tailored messages to participants over a 4-week period. The messages will use Motivational Interviewing strategies. The messages are designed to elicit a response from the participant. Health coaches will also respond to participant replies consistent with Motivational Interviewing over a course of 4 weeks.
BEHAVIORALEnhanced Usual Care (EUC)
The brochure covers educational topics like opioid storage and disposal and overdose prevention, as well as resources such as naloxone, suicide hotlines, mental health, and substance use treatment. It will be available online and in print.
Sponsors
University of Michigan
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
16 Years to 30 Years
Healthy volunteers
No
Inclusion criteria
* Aged 16-30 years * Seeking care in Michigan Medicine emergency department (ED) * Ability to read/comprehend and communicate in English * Medically \& cognitively able to provide consent or assent * Prescription opioid use plus \>=1 other risk factor (misuse positive for marijuana, other illicit drugs, other prescription drug misuse; binge drinking; depression or suicidality) or opioid misuse \[prescription opioid misuse or illicit opioid use (e.g., heroin, fentanyl)\]
Exclusion criteria
* Presenting with acute sexual assault, acute suicidality or a current cancer diagnosis/are currently receiving cancer treatment * Current pregnancy at baseline * History of injection drug use within last 12 months * High risk for opioid use disorder * Enrolled in Aim 1
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Misuse Severity Score (Past 3-month) | 3, 6, and 12 months | Alcohol Smoking and Substance Involvement Screening Test severity risk score (severity of prescription opioids/heroin consumption and consequences, scores range 0-27 per subscale; the prescription opioid and heroin subscales are summed such that total possible range on this measure is 0-54, higher score indicates worse outcomes/more severity). Note: missing data was imputed and median scores are presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overdose Risk Behaviors | 3, 6, and 12 months | Opioid-related risk behaviors (score ranges from 0-32, higher score indicates worse outcomes) |
| Past 30-day Opioid Misuse (Dichotomized: 1+ Day vs. 0 Days) | 3, 6, and 12 months | Item based on the Addiction Severity Index (modified), data was collected for days of opioid misuse and possible scores ranged from 0-60. For statistical analysis, responses were dichotomized to 0 days vs. 1+ days, thus results are presented as # of participants reporting past 30-day opioid misuse. |
| Other Drug and Alcohol Use Severity | 3, 6, and 12 months | Substance use severity index (based on 7-items measuring frequency of: alcohol consumption, cannabis consumption, prescription sedative misuse, prescription stimulant misuse, cocaine consumption, methamphetamine consumption, hallucinogens consumption), sum of all 7 items with response options for each substance: 0 = never, 1= 1 time, 2= 2 times, 3= Once a month, 4= 2 to 3 times a month, 5= Once a week, 6= 2 times a week, 7= 3 to 4 times a week, 8= Nearly every day, 9= Every day, 10= More than once a day; total possible range is 0-70, higher scores indicate worse outcome/greater severity |
| Substance Use Consequences | 3, 6, and 12 months | Adapted alcohol (14 items), cannabis (14 items), and/or opioid-related consequences (14 items); response options for each item on each subscale were: 0=Never, 1=1 time, 2=2 times, 3=3-5 times, 4=6-9 times, 5=10-19 times, 6=20 or more times. Measure comprises total of sum of items across 3 subscales with a possible range of 0 to 252, higher score indicates worse outcomes/more consequences |
| Impaired Driving | 3, 6, and 12 months | Adapted items from Young Adult Driving Questionnaire (5 items; score ranges from 0-30; higher score indicates worse outcome) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMaureen Walton, PhD
University of Michigan
PRINCIPAL_INVESTIGATORErin Bonar, PhD
University of Michigan
Participant flow
Recruitment details
Recruitment occurred from January 2021 through February 2024 with patients who were attending the Emergency Department or had a recent Emergency Department visit.
Pre-assignment details
N/A, randomization was the point of enrollment in this study.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized 16-25 years | 777 Participants |
| Age, Customized 26-30 years | 378 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 25 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 267 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 61 Participants |
| Race (NIH/OMB) Black or African American | 190 Participants |
| Race (NIH/OMB) More than one race | 19 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 204 Participants |
| Sex: Female, Male Female | 209 Participants |
| Sex: Female, Male Male | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 284 | 2 / 286 | 1 / 295 | 1 / 290 |
| other Total, other adverse events | 0 / 284 | 0 / 286 | 1 / 295 | 0 / 290 |
| serious Total, serious adverse events | 17 / 284 | 5 / 286 | 15 / 295 | 7 / 290 |
Outcome results
None listed