NCT03863353: STOMPYA

Scenario Tailored Opioid Messaging Program (STOMP) to Improve Risk Understanding in Young Adults

Completed NA Results posted Last updated 6 April 2022

What this trial tests

NA trial testing Educational Intervention in Pain, Postoperative in 503 participants. Completed in 1 December 2021.

Timeline

1 November 2019

Primary endpoint
1 December 2021

1 December 2021

Quick facts

Lead sponsor	University of Michigan
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	triple
Primary purpose	prevention
Enrollment	503
Start date	1 November 2019
Primary completion	1 December 2021
Estimated completion	1 December 2021
Sites	2 locations across United States

Drugs / interventions tested

• Educational Intervention

Conditions studied

• Pain, Postoperative — all drugs for Pain, Postoperative →
• Medication Adherence — all drugs for Medication Adherence →
• Opioid Use — all drugs for Opioid Use →
• Knowledge, Attitudes, Practice — all drugs for Knowledge, Attitudes, Practice →

Sponsor

University of Michigan

Who can join

Adults 15 to 24, any sex, with Pain, Postoperative or Medication Adherence. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Opioid Risk Perception Primary · Baseline, day 14, 3 months post intervention

Perceived riskiness of opioid misuse (0-40 where 40 indicates highest risk perception)

Baseline

Group	Value	95% CI
Education Intervention	31.4	± 0.85
Control	31.1	± 1.01

Day 14

Group	Value	95% CI
Education Intervention	32.8	± .65
Control	30.02	± 1.12

Month 3

Group	Value	95% CI
Education Intervention	31.0	± .62
Control	29.8	± 1.21

Opioid Misuse Intention Decisions Secondary · 3 months post intervention

Number of participants with opioid misuse intentions and behaviors

Misuse Intentions

Group	Value	95% CI
Education Intervention	47
Control	38

Misuse behavior

Group	Value	95% CI
Education Intervention	18
Control	12

Adverse events — posted to ClinicalTrials.gov

Time frame: 3 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Education Intervention

Serious: 9/258 (3%)

Deaths: 0/258

Control

Serious: 6/201 (3%)

Deaths: 0/201

Serious adverse events (1 terms)

Reaction	System	Education Intervention	Control
Hospitalization	Surgical and medical procedures	—	—

Most-reported serious reactions: Hospitalization.

Data from ClinicalTrials.gov NCT03863353 adverse events section.

Sponsor's own description

Legitimate prescription opioid use during adolescence has been associated with later prescription opioid misuse and substance use disorder symptoms during adulthood. Thus, primary prevention interventions for older adolescents and young adults (15-24 yrs) at the time of prescribing are imperative.

The goal of our research is to improve opioid analgesic safety and efficacy by optimizing opioid risk recognition and informed decision-making among 15-24 year olds who are prescribed these agents for home use. Young adults and older adolescents who manage their own prescription pain medicines need to recognize opioid-related risks and make decisions that will both reduce these risks yet ensure effective pain relief. The proposed research will evaluate new strategies to help subjects learn about opioid risks and make safe and effective analgesic decisions. 355 subjects who are undergoing an elective surgical procedure will be recruited. Subjects will be randomized to receive the new educational routine information. Subjects' knowledge and perceptions will be evaluated at baseline and at critical times after surgery.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Enhancing risk perception may be insufficient to curtail prescription opioid use and misuse among youth after surgery: A randomized controlled trial.
   Voepel-Lewis T, Veliz P, Heinze J, Boyd CJ, et al · · 2022 · cited 3× · PMID 35216854 · DOI 10.1016/j.pec.2022.01.015