Opioid-Related DisordersNCT02751762
A Prospective Investigation of the Risks of Opioid Misuse, Abuse, and Addiction Among Patients Treated With Opioids for the Treatment of Chronic Pain
An observational study of Opioid-Related Disorders and Opiate Addiction, run by Member Companies of the Opioid PMR Consortium at 2 sites in United States.
Trial summary
The purpose of this study is to quantify the serious risks of prescription opioid misuse or abuse or opioid use disorder (OUD) associated with the long term use of opioid analgesics for management of chronic pain, among patients prescribed opioid products. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Opioid-Related Disorders, Opiate Addiction, Narcotic Abuse
- What is being tested?
- Observation Only
- How many people
- 3,600 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2017to 31 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Of the approximately 2300 eligible subjects in the prospective study, approximately 2200 will be from the HCSRN sites, 25 from the VA, and a total of 100 from the PBRN sites. Sampling and recruitment strategies for the cross-sectional study will parallel those used to identify the prospective sample.
Who may be able to join
- Initiation* of ER/LA opioid therapy that includes 28+ days of an ER/LA followed by a subsequent ER/LA prescription (ER/LA initiators) or initiation** of long-term opioid therapy (LtOT - 90+ days of use) with ER/LA and/or Schedule II IR/SA opioids (LtOT initiators).
- Age 18-79 years at incident prescription
- Enrolled in the health plan (HCSRN sites) or regularly receiving care in the health system (VA and PBRNs) for at least 12 months prior to incident use of opioids
- Ability to complete interview/self-administered questionnaires in English
- Willing and able to provide informed consent
- Initiation or new use of ER/LA therapy defined as no ER/LA opioid use in the prior six-months ** Initiation or new LtOT use defined as no ER/LA or Schedule II IR/SA opioid use in the prior six-months
Show all 10Show fewer
- Regular opioid use in the past year with at least 1 prescription for an ER/LA opioid. See Figure 4 for specifics on how these criteria are operationalized.
- Age 18-79 years at index prescription Enrolled in the health plan (HCSRN sites) or regularly receiving care in the health system (VA and PBRNs) for at least 12 months prior to index date.
- Ability to complete interview/self-administered questionnaires in English
- Willing and able to provide informed consent
Who cannot join
- Not using an ER/LA or Schedule II IR/SA opioid at the time of recruitment or first interview (self-report)
- Cognitive impairment that interferes with the ability to consent or participate in the interview
- Unavailable for 12 months of follow-up (self-report)
- Receiving hospice care (EHR and recruitment screening)
- Diagnosis of a terminal illness in the prior 12 months per chart review or recruitment screening
- Existing opioid use disorder (ICD-9 and ICD-10 diagnosis codes)
Show all 11Show fewer
- Medication assisted treatment with methadone or buprenorphine (self-report)
- Eligibility Criteria - Cross Sectional Study:
- Not using an opioid at the time of recruitment or first interview (self-report)
- Cognitive impairment that interferes with the ability to consent or participate in the interview
- Receiving hospice care (EHR and recruitment screening)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Kaiser Permanente Northwest
Portland, Oregon, 97210
Kaiser Permanente Washington
Seattle, Washington, 98112
About this study
The purpose of this study is to quantify the serious risks of prescription opioid misuse or abuse or opioid use disorder (OUD) associated with the long term use of opioid analgesics for management of chronic pain, among patients prescribed opioid products.
Read the detailed description
The Food and Drug Administration (FDA) has asked the companies that are New Drug Application (NDA) holders of extended-release/long-acting (ER/LA) opioids to conduct one or more studies to provide quantitative estimates of the serious risks of prescription opioid misuse or abuse or opioid use disorder associated with long-term use of opioid analgesics for management of chronic pain, among patients prescribed opioid products. Although abuse and misuse of prescription opioids have increased over the past decade, there is debate about the magnitude of misuse, abuse, and addiction among patients who are treated with prescription opioids for chronic pain. Further, although there appears to be comorbidity of opioid use disorders with other substance use and psychiatric disorders, there is insufficient data to estimate how the risk of these outcomes varies by the presence of risk factors among patients treated with opioids long-term. This study seeks to fill that gap. The primary objective is to quantify the serious risks of prescription opioid misuse or abuse or OUD associated with long-term use of opioid analgesics for management of chronic pain among patients prescribed opioid products. Patients will be recruited from seven Health Care System Research Network (HCSRN) sites; one U.S. Department of Veterans Affairs (VA) site; and clinics participating in two Primary Care Practice-Based Research Network sites. The data sources for the proposed study will be: 1) patient reported outcomes through in-person interviews (or phone if unavailable to participate in-person), 2) web-based assessments (or phone if unable to complete via web), and 3) electronic medical record and claims data. The study design includes two components: 1) a prospective longitudinal study of patients who have recently initiated long-term opioid therapy or initiated ER/LA opioid therapy, and 2) a cross-sectional study of patients who have been treated with opioids (including at least one ER/LA opioid) for at least one year.
- Conditions
- Opioid-Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Being tested
- Observation Only
- Medical subject headings
- Opioid-Related Disorders, Narcotic-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation OnlyOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| Prospective Longitudinal Cohort | Patients who have recently initiated long-term opioid therapy or initiated ER/LA opioid therapy Receives: Other: Observation Only | |
| Cross-sectional Cohort | Patients who have been treated with opioids (including at least one ER/LA opioid) for greater than one year Receives: Other: Observation Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prospective Longitudinal study: Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)
Estimation of the incidence of misuse and abuse associated with long-term use of opioids for chronic pain.
Measured: Change from baseline at up to one year
Prospective Longitudinal study: Psychiatric Research Interview for Substance and Mental Disorders, adapted for assessing addiction to opioid analgesics (PRISM-5-OP)
Estimation of the incidence of addiction associated with long-term use of opioids for chronic pain.
Measured: Change from baseline at one year
Cross sectional Study: Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)
Estimation of the prevalence of misuse and abuse associated with long term use of opioids for chronic pain.
Measured: Day 1 Assessment
Cross sectional Study: Psychiatric Research Interview for Substance and Mental Disorders, adapted for assessing addiction to opioid analgesics (PRISM-5-OP)
Estimation of the prevalence of addiction associated with long term use of opioids for chronic pain.
Measured: Day 1 Assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study start1 Nov 2017
- Primary completion1 Oct 2021
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Member Companies of the Opioid PMR Consortium
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kaiser Permanente
- Responsible party
- Sponsor
- Investigators
- Kenneth R Petronis, Study chair, Epi Ideas LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02751762
- Sponsor's protocol ID
- Observational Study 3033-1
- Other IDs
- Study 3033-1
- Status last verified
- Jan 2025
- First submitted
- 6 Apr 2016
- Last updated
- 29 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yarborough BJH, Smith N, Stumbo SP, Janoff S, Keast E, Wartko PD, Yeung K, Zhu W, Petronis KR, Ahmedani BK, Andrade SE, Campbell CI, Clark RE, Cottler LB, Hechter RC, Mudumbai SC, Starrels JL, Boudreau DM. Incidence of opioid use disorder among patients prescribed long-term opioid therapy: An observational study. Drug Alcohol Depend. 2026 Oct 8;288:113385. doi: 10.1016/j.drugalcdep.2026.113385. Online ahead of print.
PubMed 42879916
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Investigation of the Risks of Opioid Misuse, Abuse, and Addiction Among Patients Treated With Opioids for the Treatment of Chronic Pain
- ClinicalTrials.gov ID
- NCT02751762
- Acronym / sponsor ID
- Observational Study 3033-1
- Conditions
- Opioid-Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,600 participants (actual)
- Lead sponsor
- Member Companies of the Opioid PMR ConsortiumIndustry (pharma, biotech, devices)
- Collaborators
- Kaiser Permanente
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 26 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to quantify the serious risks of prescription opioid misuse or abuse or opioid use disorder (OUD) associated with the long term use of opioid analgesics for management of chronic pain, among patients prescribed opioid products.
Detailed description
The Food and Drug Administration (FDA) has asked the companies that are New Drug Application (NDA) holders of extended-release/long-acting (ER/LA) opioids to conduct one or more studies to provide quantitative estimates of the serious risks of prescription opioid misuse or abuse or opioid use disorder associated with long-term use of opioid analgesics for management of chronic pain, among patients prescribed opioid products. Although abuse and misuse of prescription opioids have increased over the past decade, there is debate about the magnitude of misuse, abuse, and addiction among patients who are treated with prescription opioids for chronic pain. Further, although there appears to be comorbidity of opioid use disorders with other substance use and psychiatric disorders, there is insufficient data to estimate how the risk of these outcomes varies by the presence of risk factors among patients treated with opioids long-term. This study seeks to fill that gap. The primary objective is to quantify the serious risks of prescription opioid misuse or abuse or OUD associated with long-term use of opioid analgesics for management of chronic pain among patients prescribed opioid products. Patients will be recruited from seven Health Care System Research Network (HCSRN) sites; one U.S. Department of Veterans Affairs (VA) site; and clinics participating in two Primary Care Practice-Based Research Network sites. The data sources for the proposed study will be: 1) patient reported outcomes through in-person interviews (or phone if unavailable to participate in-person), 2) web-based assessments (or phone if unable to complete via web), and 3) electronic medical record and claims data. The study design includes two components: 1) a prospective longitudinal study of patients who have recently initiated long-term opioid therapy or initiated ER/LA opioid therapy, and 2) a cross-sectional study of patients who have been treated with opioids (including at least one ER/LA opioid) for at least one year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective Longitudinal Cohort | – | Other: Observation OnlyPatients who have recently initiated long-term opioid therapy or initiated ER/LA opioid therapy |
| Cross-sectional Cohort | – | Other: Observation OnlyPatients who have been treated with opioids (including at least one ER/LA opioid) for greater than one year |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Of the approximately 2300 eligible subjects in the prospective study, approximately 2200 will be from the HCSRN sites, 25 from the VA, and a total of 100 from the PBRN sites. Sampling and recruitment strategies for the cross-sectional study will parallel those used to identify the prospective sample.
Key inclusion criteria (10 listed)
- Initiation* of ER/LA opioid therapy that includes 28+ days of an ER/LA followed by a subsequent ER/LA prescription (ER/LA initiators) or initiation** of long-term opioid therapy (LtOT - 90+ days of use) with ER/LA and/or Schedule II IR/SA opioids (LtOT initiators).
- Age 18-79 years at incident prescription
- Enrolled in the health plan (HCSRN sites) or regularly receiving care in the health system (VA and PBRNs) for at least 12 months prior to incident use of opioids
- Ability to complete interview/self-administered questionnaires in English
- Willing and able to provide informed consent
Key exclusion criteria (11 listed)
- Not using an ER/LA or Schedule II IR/SA opioid at the time of recruitment or first interview (self-report)
- Cognitive impairment that interferes with the ability to consent or participate in the interview
- Unavailable for 12 months of follow-up (self-report)
- Receiving hospice care (EHR and recruitment screening)
- Diagnosis of a terminal illness in the prior 12 months per chart review or recruitment screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation OnlyNo Intervention | Other | Cross-sectional Cohort, Prospective Longitudinal Cohort |
Primary outcome
Prospective Longitudinal study: Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)
Time frame: Change from baseline at up to one year
Estimation of the incidence of misuse and abuse associated with long-term use of opioids for chronic pain.
Prospective Longitudinal study: Psychiatric Research Interview for Substance and Mental Disorders, adapted for assessing addiction to opioid analgesics (PRISM-5-OP)
Time frame: Change from baseline at one year
Estimation of the incidence of addiction associated with long-term use of opioids for chronic pain.
Cross sectional Study: Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)
Time frame: Day 1 Assessment
Estimation of the prevalence of misuse and abuse associated with long term use of opioids for chronic pain.
Cross sectional Study: Psychiatric Research Interview for Substance and Mental Disorders, adapted for assessing addiction to opioid analgesics (PRISM-5-OP)
Time frame: Day 1 Assessment
Estimation of the prevalence of addiction associated with long term use of opioids for chronic pain.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Derived from this study: PubMed 42879916Yarborough BJH, Smith N, Stumbo SP, Janoff S, Keast E, Wartko PD, Yeung K, Zhu W, Petronis KR, Ahmedani BK, Andrade SE, Campbell CI, Clark RE, Cottler LB, Hechter RC, Mudumbai SC, Starrels JL, Boudreau DM. Incidence of opioid use disorder among patients prescribed long-term opioid therapy: An observational study. Drug Alcohol Depend. 2026 Oct 8;288:113385. doi: 10.1016/j.drugalcdep.2026.113385. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth R Petronis study chair
Epi Ideas LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid-Related Disorders and Opiate Addiction, run by Member Companies of the Opioid PMR Consortium at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prospective Longitudinal study: Prescription Opioid Misuse and Abuse Questionnaire (POMAQ) (time frame: Change from baseline at up to one year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02751762, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.