Pain and Medication Use Following Surgery

Opioid Use Clinical Trial

— SODAS  

Official title:

Safe Opioid Disposal After Surgery Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03179566
• Other study ID #: HUM00129418
• Secondary ID: MA-2017
• Status: Completed
• Phase: N/A
• First received: June 5, 2017
• Last updated: September 8, 2017
• Start date: June 6, 2017
• Est. completion date: September 1, 2017

Study information

• Verified date: September 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients will be randomized to one of two interventions intended to facilitate safe disposal of opioids after cessation following surgery. For pragmatic reasons, participants will be randomized by day to either the information sheet or the disposal bag using a block randomization schedule. To ensuring adequate sample size, patients will be enrolled for a ~4-week period following the 2-week usual care run in period. In the event that the sample size estimate has not been reached after the 4-week intervention period, additional patients will be enrolled accordingly.

Description:

The lack of evidence-based guidelines for postoperative opioid prescribing has contributed to a surplus of opioid pills within our patients' homes and communities, increasing the potential for diversion and nonmedical use. A recent study suggests that for outpatient general surgery procedures, roughly 72% of prescribed opioids go unused. Current opioid disposal options are limited to DEA-authorized opioid collectors, including select law enforcement agencies, pharmacies, or organized pill drop events, and many patients remain unaware of these avenues. Several studies have found that few patients have knowledge about opioid disposal options and even fewer dispose of their unconsumed opioids.

Unconsumed opioids pose a diversion risk. In the 2011 National Survey on Drug Use and Health, 70.8% of those who used a prescription medication non-medically obtained the medication from a friend or relative, with or without their knowledge. Additionally, nonmedical prescription opioid use is a common pathway to heroin use. Importantly, over 80% of young intravenous drug users report initiation of prescription opioid misuse prior to heroin.

Considering that 40% of the prescriptions written by surgeons are for opioids and patients frequently have excess opioids and limited options for and/or knowledge of opioid disposal, the present study will provide patients with information and novel options for opioid disposal as part of the surgical care pathway.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 391
• Est. completion date: September 1, 2017
• Est. primary completion date: September 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Scheduled for surgery at Michigan Medicine's East Ann Arbor Ambulatory Surgery & Medical Procedures Center

Exclusion Criteria:

• Unable to speak English

• Inability to understand or complete the surveys

• Other conditions that preclude meaningful participation in the study

Related Conditions & MeSH terms

• Opioid Use

Intervention

Behavioral:
• Information Sheet
Patients will receive an informational sheet about how to dispose of leftover opioid medication during discharge. Nurses will provide this information sheet and a brief, scripted description of its use and importance of safe disposal at the time of discharge following surgery.
• Deterra Drug Deactivation System
This system is a pouch that deactivates prescription drugs, rendering them ineffective for misuse and safe for regular garbage disposal. It uses a patented activated carbon technology to deactivate drugs, including pills, liquids, and patches, and has been found to be 99% percent effective in studies funded by the National Institute of Drug Abuse (NIDA). Additionally, the pouches are made from environmentally friendly materials and contain active ingredients that are considered non-toxic and pose minimal risk, according to their MSDS. Nurses will provide the Deterra bag and a brief, scripted description of its use and importance of safe disposal at the time of discharge following surgery.

Locations

Country	Name	City	State
United States	East Ann Arbor Ambulatory Surgery & Medical Procedures Center - Michigan Medicine	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Michigan Department of Health and Human Services

Country where clinical trial is conducted

United States, 

References & Publications (13)

Boyd CJ, Esteban McCabe S, Teter CJ. Medical and nonmedical use of prescription pain medication by youth in a Detroit-area public school district. Drug Alcohol Depend. 2006 Jan 4;81(1):37-45. Epub 2005 Jul 22. — View Citation

Egan KL, Gregory E, Sparks M, Wolfson M. From dispensed to disposed: evaluating the effectiveness of disposal programs through a comparison with prescription drug monitoring program data. Am J Drug Alcohol Abuse. 2017 Jan;43(1):69-77. doi: 10.1080/00952990.2016.1240801. Epub 2016 Oct 31. — View Citation

Fortuna RJ, Robbins BW, Caiola E, Joynt M, Halterman JS. Prescribing of controlled medications to adolescents and young adults in the United States. Pediatrics. 2010 Dec;126(6):1108-16. doi: 10.1542/peds.2010-0791. Epub 2010 Nov 29. — View Citation

Hill MV, McMahon ML, Stucke RS, Barth RJ Jr. Wide Variation and Excessive Dosage of Opioid Prescriptions for Common General Surgical Procedures. Ann Surg. 2017 Apr;265(4):709-714. doi: 10.1097/SLA.0000000000001993. — View Citation

Lankenau SE, Teti M, Silva K, Jackson Bloom J, Harocopos A, Treese M. Initiation into prescription opioid misuse amongst young injection drug users. Int J Drug Policy. 2012 Jan;23(1):37-44. doi: 10.1016/j.drugpo.2011.05.014. Epub 2011 Jun 20. — View Citation

Levy B, Paulozzi L, Mack KA, Jones CM. Trends in Opioid Analgesic-Prescribing Rates by Specialty, U.S., 2007-2012. Am J Prev Med. 2015 Sep;49(3):409-13. doi: 10.1016/j.amepre.2015.02.020. Epub 2015 Apr 18. — View Citation

Lewis ET, Cucciare MA, Trafton JA. What do patients do with unused opioid medications? Clin J Pain. 2014 Aug;30(8):654-62. doi: 10.1097/01.ajp.0000435447.96642.f4. — View Citation

McCabe SE, West BT, Boyd CJ. Leftover prescription opioids and nonmedical use among high school seniors: a multi-cohort national study. J Adolesc Health. 2013 Apr;52(4):480-5. doi: 10.1016/j.jadohealth.2012.08.007. Epub 2012 Nov 22. — View Citation

Reddy A, de la Cruz M, Rodriguez EM, Thames J, Wu J, Chisholm G, Liu D, Frisbee-Hume S, Yennurajalingam S, Hui D, Cantu H, Marin A, Gayle V, Shinn N, Xu A, Williams J, Bruera E. Patterns of storage, use, and disposal of opioids among cancer outpatients. Oncologist. 2014 Jul;19(7):780-5. doi: 10.1634/theoncologist.2014-0071. Epub 2014 May 27. — View Citation

Rudd RA, Aleshire N, Zibbell JE, Gladden RM. Increases in Drug and Opioid Overdose Deaths--United States, 2000-2014. MMWR Morb Mortal Wkly Rep. 2016 Jan 1;64(50-51):1378-82. doi: 10.15585/mmwr.mm6450a3. — View Citation

Tanabe P, Paice JA, Stancati J, Fleming M. How do emergency department patients store and dispose of opioids after discharge? A pilot study. J Emerg Nurs. 2012 May;38(3):273-9. doi: 10.1016/j.jen.2011.09.023. Epub 2011 Dec 26. — View Citation

Vaughn MG, Nelson EJ, Salas-Wright CP, Qian Z, Schootman M. Racial and ethnic trends and correlates of non-medical use of prescription opioids among adolescents in the United States 2004-2013. J Psychiatr Res. 2016 Feb;73:17-24. doi: 10.1016/j.jpsychires.2015.11.003. Epub 2015 Nov 11. — View Citation

Voepel-Lewis T, Wagner D, Tait AR. Leftover prescription opioids after minor procedures: an unwitting source for accidental overdose in children. JAMA Pediatr. 2015 May;169(5):497-8. doi: 10.1001/jamapediatrics.2014.3583. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drug disposal	Patient-reported disposal of left-over opioid medications in any manner	4 weeks post-surgery
Secondary	Opioid disposal technique	Patient-reported technique for disposal of left-over opioid medications specifically assessing for safe disposal using recommended disposal methods	4 weeks post-surgery

External Links

•   Opioid painkiller prescribing: where you live makes a difference (2014)