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Protocol - Co-use of Opioids with Other Drugs and Overdose Risk

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Description

The Opioid Overdose Risk Behavior Scale, Version 2 (ORBS-2) is a 39-item interviewer-administered questionnaire with six subscales that cover use and misuse of prescription opioids and also combined use with other drugs. Respondents first identify which drugs they use and then are asked about drug use combinations.

Specific Instructions

The PhenX Substance Use and Recovery Working Group (WG) notes that investigators interested in using ORBS-2 in a nonclinical or nonresearch setting should contact the corresponding authors, LCE201@nyu.edu and ASB19@nyu.edu.

While the ORBS-2 was validated using an online self computer-administered format, the authors of the ORBS-2 and the Substance Use and Recovery WG acknowledge that it can also be administered by an interviewer.

The Substance Use and Recovery WG notes that researchers may want to analyze subscales separaterly.

Protocols may include terms and language that could be triggering to respondents. Investigators are encouraged to have resources in place to help respondents cope with triggers as needed.

Terminology related to substances, substance use, and recovery is fluid. Updates in protocol language may be appropriate based on circumstance. Suggestions for revision have been offered to update answer responses or other components of the questionnaires to account for the constantly changing landscape. These suggestions have not been tested or validated in research studies but may be considered by investigators to enhance relevance.

Availability

This protocol is freely available; permission not required for use.

Protocol

Opioid Overdose Risk Behavior Scale, Version 2 (ORBS-2)

Guide to use, Overview: The ORBS-2 is designed as a modular series of subscales, with each subscale addressing relatively unique patterns of risky behavior that each independently contribute to overdose risk. To reduce participant burden, a checklist of drugs is provided to all participants (referred to as Gateway questions), and each participant is asked to first indicate which drugs they have used in the past 30 days. Based on the responses to the Gateway questions, certain items then can be pre-filled or programmed at 0. For the subscale items, responses are given values on a 0-30 scale, representing the number of days that the participant has used each of the drugs over the past 30 days.

  • Subscale A (Prescription Opioid Misuse), Subscale B (Risky Non-Injection Use) or Subscale C (Injection Drug Use & Speedballing) can be used alone or in combination with any other scale

  • Subscales D-F all include increasingly complex combinations of substance use. Each subscale requires administering the subscale before it:

    • Subscale D (Opioid & Alcohol Combinations) requires administering subscale C first

    • Subscale E (Opioid & Benzodiazepine Combinations) requires administering subscale C AND D first

    • Subscale F (Higher Order Polysubstance Combinations) requires administering subscales C, D, AND E first

Instructions for Researchers:

  • Gateway Questions: Participants must first answer gateway questions, which indicate yes/no to substances used in the past 30 days. These gateway questions assist in the skip logic for the subsequent subscales.
  • Selecting Subscales: Researchers are encouraged to use as many of the subscales as possible; however, if they would like to offer a smaller number of subscales, they may wish to read the original manuscript and refer to Table 3 (which describes the association between various ORBS-2 subscales and various clinical constructs) to balance time, burden, and specific research questions.

  • Scoring and Interpretation: Subscale scores are represented as an average of all items, with higher scores conferring greater risk.

ITEM TEXT AND SCORING FOR RESEARCHERS:

As tested, the ORBS-2 was an interactive (i.e., online, computer-administered) instrument where items will display based on their relevance to the participant and skip if they are not relevant. This can be recreated in most survey hosting websites through “SKIP” rules for specific blocks of items or questions. The following skip rules will allow you to direct participants to the most relevant questions. This includes skipping the overall ORBS measure if the participant has not used opioids in the last 30 days and/or skipping select subscales (A, B, D, E, F) based on the responses to specific items.

In order to account for potential participant error, there are also validation questions built into the gateway checklist and into Subscale A.

Note on administration:
Subscale A (Prescription Opioid Misuse) requires Gateway Questions A–F
Subscale B (Risky Non-Injection Use), , requires Gateway Questions A–F
Subscale C (Injection Drug Use & Speedballing) requires Gateway Questions G and H
Subscale D (Opioid & Alcohol Combinations) requires Gateway Questions G–I and Subscale C
Subscale E (Opioid & Benzodiazepine Combinations) requires Gateway Questions G–J and Subscales C and D
Subscale F (Higher Order Polysubstance Combinations) requires Gateway Questions G–K and Subscales C–E

SKIP RULES:
IF Gateway questions A-F = 0 AND ORBS1X = 0; SKIP all ORBS2 questions and SET ALL ITEMS = 0
IF Gateway Question A = 0; SKIP Subscale A and SET Subscale A items = 0
IF Gateway Question A = 0 AND Gateway Question B = 0; SKIP Subscale B and SET Subscale B items = 0
IF Gateway Question I = 0; SKIP Subscale D
IF Gateway Question J = 0; SKIP Subscale E
IF Gateway Question K = 0; SKIP Subscale F

Note: Depending on your willingness to program, you can streamline further by omitting questions within specific subscales based on gateway questions. For example, you can drop any questions that mention amphetamines from all subscales C-F if participants answer BOTH Gateway Question G and Gateway Question H at 0.

GATEWAY QUESTIONS:

The following questions refer to medicines and other drugs you may have taken in the past 30 days. Please think back on the past 30 days, and answer to the best of your ability.

Please look at the list of drugs below and check all that you have used at any point in the last 30 days:

Used in Last 30 Days?

(check one)

YES

NO

  1. Opioid painkiller pills (Oxy, Lortab, Lorcet, Percocet, Roxicet, etc.)

1

0

  1. Heroin

1

0

  1. Kratom

1

0

  1. Codeine syrup (aka purple drank or sizurp)

1

0

  1. Methadone

1

0

  1. Buprenorphine (Suboxone, Subutex)

1

0

  1. Cocaine or Crack

1

0

  1. Amphetamine or methamphetamine substances (including ADHD meds like Adderall and Ritalin)

1

0

  1. Alcohol

1

0

  1. Benzo (diazepine) anti-anxiety pills (Valium, Xanax, Klonopin, etc.)

1

0

  1. Sleeping pills (Ambien, Restoril, Halcion, Sonata, etc.)

1

0

NOTE: Please note that the term "opioid" refers to a category of drug used primarily to manage physical pain. Pills such as Percocet, Oxycontin, Vicodin, Tramadol and Tylenol 3s are all opioids. So are Buprenorphine and Methadone, Opana, and Fentanyl. Codeine cough syrup (aka purple drank, sizurp) and fentanyl patches are opioids. Heroin is an opioid too. All are either based on or derived from the poppy flower which is used to produce opium, from which we get the term "opioid."

ORBS1-X:

X. On how many days in the past 30 did you take any opioids at all that were not prescribed to you by a doctor? This could include painkillers, methadone, or buprenorphine you got from a friend or dealer as well as heroin.

0-30 [numeric]

VALIDATION NOTES:
IF Gateway X > 0 AND Gateway a-f = 0, THEN STATE TO PARTICIPANTS:

There seems some confusion. You did not choose any opioid substances from the list on the last question. Please correct your responses before continuing or contact the project staff.

SUBSCALE A:

YES

NO

Y. Do you have a prescription for an opioid painkiller?

1

0

VALIDATION NOTES:
IF Gateway Question Y = 0, SKIP questions 1 and 2 and SET their values to 0.

# of days

1. On how many days in the past 30 did you use a prescribed opioid painkiller?

0-30

2. On how many days in the past 30 did you use more of your prescribed opioid painkillers than advised?

0-30

SUBSCALE B:

# of days

3. On how many days in the past 30 did you use opioid painkillers that you got from someone else who has a prescription or that you know came from a pharmacy?

0-30

4. On how many days in the past 30 did you use opioid painkillers that you got from a dealer or someone else who might not have a doctor’s prescription?

0-30

5. On how many days in the past 30 did you crush and snort opioid painkillers?

0-30

6. On how many days in the past 30 did you crush and smoke or vaporize opioid painkillers?

0-30

7. On how many days in the past 30 did you smoke or vaporize (aka chase the dragon) heroin?

0-30

SUBSCALE C:

# of days

8. On how many days in the past 30 did you inject heroin?

0-30

9. On how many days in the past 30 did you inject any opioid other than heroin (crushed pills, methadone, or buprenorphine, for example)?

0-30

10. On how many days in the past 30 did you use any opioids AND use a cocaine or amphetamine type stimulant within the same 6-hour period?

0-30

11. On how many days in the past 30 did you use any opioids AND a cocaine or amphetamine type stimulant at the same time (also known as a speedball)?

0-30

SUBSCALE D:

# of days

12. On how many days in the past 30 did you use any opioids AND drink alcohol within the same 6-hour period?

0-30

13. On how many days in the past 30 did you use any opioids and drink 4 or more alcoholic beverages quickly within the same 6-hour period?

0-30

14. On how many days in the past 30 did you use any opioids and use a cocaine or amphetamine type stimulant AND drink alcohol within the same 6-hour period?

0-30

SUBSCALE E:

# of days

15. On how many days in the past 30 did you use any opioids AND take benzos within the same 6-hour period?

0-30

16. On how many days in the past 30 did you use any opioids and take benzos AND use a cocaine or amphetamine type stimulant within the same 6-hour period?

0-30

17. On how many days in the past 30 did you use any opioids and take benzos AND drink alcohol within the same 6-hour period?

0-30

18. On how many days in the past 30 did you use any opioids and use benzos and use a cocaine or amphetamine type stimulant AND drink alcohol within the same 6-hour period?

0-30

SUBSCALE F:

# of days

19. On how many days in the past 30 did you use any opioids AND take prescription sleeping pills (within the same 6-hour period?

0-30

20. On how many days in the past 30 did you use any opioids and take a prescription sleeping pill AND use a cocaine or amphetamine type stimulant within the same 6-hour period?

0-30

21. On how many days in the past 30 did you use any opioids and take a sleeping pill and drink alcohol within the same 6-hour period?

0-30

22. On how many days in the past 30 did you use any opioids and take benzos AND take a prescription sleeping pill within the same 6-hour period?

0-30

23. On how many days in the past 30 did you use any opioids and use benzos and take a prescription sleeping pill and use a cocaine or amphetamine type stimulant within the same 6-hour period?

0-30

24. On how many days in the past 30 did you use any opioids and take a prescription sleeping pill and use a cocaine or amphetamine type stimulant AND drink alcohol within the same 6-hour period?

0-30

25. On how many days in the past 30 did you use any opioids and use benzos and take a prescription sleeping pill AND drink alcohol within the same 6-hour period?

0-30

26. On how many days in the past 30 did you use any opioids and use benzos and take a prescription sleeping pill and use a cocaine or amphetamine type stimulant AND drink alcohol within the same 6-hour period?

0-30

Personnel and Training Required
None
Equipment Needs
None
Requirements
Requirement CategoryRequired
Major equipment No
Specialized training No
Specialized requirements for biospecimen collection No
Average time of greater than 15 minutes in an unaffected individual No
Mode of Administration

Interviewer-administered questionnaire

Lifestage

Adult

Participants

18 years or older

Selection Rationale

The Opioid Overdose Risk Behaviors-2 (ORBS-2) is a validated measure specific to opioid combinations that can provide insight into the proximal/behavioral factors of greatest concern to reduce overdose mortality

Language

English

Standards
StandardNameIDSource
Derived Variables

None

Process and Review

Not Applicable

Protocol Name from Source

Opioid Overdose Risk Behavior Scale, Version 2 (ORBS-2)

Source

Elliott, L., Crasta, D., Khan, M., Roth, A., Green, T., Kolodny, A., & Bennett, A. S. (2021). Validation of the Opioid Overdose Risk Behavior Scale, Version 2 (ORBS-2).Drug and Alcohol Dependence, 223, 108721.

General References

Khan, M. R., Hoff, L., Elliott, L., Scheidell, J. D., Pamplin, J. R., 2nd, Townsend, T. N., Irvine, N. M., & Bennett, A. S. (2023). Racial/ethnic disparities in opioid overdose prevention: Comparison of the naloxone care cascade in White, Latinx, and Black people who use opioids in New York City.Harm Reduction Journal, 20(1), 24.
https://doi.org/10.1186/s12954-023-00736-7

Protocol ID

511501

Variables
Export Variables
Variable Name Variable IDVariable DescriptiondbGaP Mapping
Assessment of Substance Use and Substance Use Disorders
Measure Name

Patterns of Polysubstance Use

Release Date

January 30, 2025

Definition

Patterns of polysubstance use refers to the characteristics (types of drugs, numbers of drugs, primary and secondary drugs, routes of administration, etc.) of the consumption of at least two substances at the same time or taken sequentially within a 24-hour period. 

Purpose

Polysubstance use behaviors, including patterns of combination, are important to understand as polysubstance use is a risk factor for overdose and overdose related mortality.  

Keywords

polysubstance use, opioid, overdose, risk behaviors, substance use, drug interactions, prescription opioids, stimulants, addiction, dependence, tolerance, withdrawal, harm reduction, overdose prevention, public health, opioid epidemic, heroin, fentanyl, stimulants, Benzodiazepines, naloxone, co-use

Measure Protocols
Protocol ID Protocol Name
511501 Co-use of Opioids with Other Drugs and Overdose Risk
511502 Alcohol and Cannabis Simultaneous Use