PainPOSTNCT02464410
Primary Care Intervention to Reduce Prescription Opioid Overdoses
A study testing Motivational intervention and Long-term opioid therapy informed consent in people with Pain and Drug Overdose, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The high rate of adverse events, including overdose, resulting from opioid pain medication use threatens the quality and safety of pain care in the Veterans Health Administration (VHA) and elsewhere and is a critical public health problem in the United States. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Drug Overdose, Opioid Use Disorders
- What is being tested?
- Motivational intervention and Long-term opioid therapy informed consent
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 299 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2016to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient at the Ann Arbor VA Medical Center receiving treatment in a primary care clinic
- Currently prescribed 20 morphine-equivalent mg (MEM) per day or more of an opioid
- Received opioid therapy for at least 90 days
- 18 years of age or older
Who cannot join
- Plans to stop opioids or reduce dose to below 20 MEM/day in the next 6 months
- Use of fentanyl, due to the difficulty in determining morphine equivalency
- A terminal cancer diagnosis
- Acute suicidality requiring immediate treatment
- Moderately severe cognitive impairment
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105-2303
About this study
The high rate of adverse events, including overdose, resulting from opioid pain medication use threatens the quality and safety of pain care in the Veterans Health Administration (VHA) and elsewhere and is a critical public health problem in the United States. Pain is a highly common condition among VHA patients, and opioid therapy constitutes a primary mode of pain treatment.
This study seeks to address this issue by conducting a randomized controlled trial of a brief conversation to improve opioid safety among Veteran patients receiving long-term opioid therapy. Veterans receiving opioid therapy for pain in primary care will be recruited and randomized to receive either a single session motivational intervention focused on safe opioid use or an equal attention control condition. The primary hypothesis is that the motivational intervention will improve opioid safety, decrease risk behaviors, aberrant opioid use, and total quantities of opioids prescribed relative to the control condition. Study findings will inform efforts to ensure the safety and well-being of Veteran patients with pain.
Read the detailed description
Adverse outcomes, including overdose, related to opioid use have increased and represent a significant threat to the safety and quality of VHA pain care as well as a national public health concern. Efforts are underway to change opioid prescribing behavior, but concurrent strategies are needed to address patient behaviors that decrease opioid safety and thus increase opioid overdose risk. Overdoses result from a range of behaviors, including taking more than prescribed, using multiple substances with synergistic effects, and injecting/snorting crushed pills to get high. Factors such as having a mental health condition have been found to increase risk of overdose among Veterans receiving opioids for pain. Given the range of risk behaviors and relevant patient factors, tailored opioid risk reduction strategies are urgently needed. Motivational enhancement (ME) is an evidence-based strategy that uses tailoring to enact behavior change through improving self-efficacy and motivation. Recent VHA initiatives to increase behavioral health providers in primary care, such as Primary Care-Mental Health Integration (PC-MHI), provide a clear opportunity to deliver ME interventions to the many patients treated for long-term pain in primary care. Although the impact of ME on overdose risk behavior is unknown, the use of an ME approach to improve opioid safety and reduce risk behaviors is potentially well-suited to the context of long-term opioid pain care, when total and immediate discontinuation of opioid use is often unfeasible.
The proposed Prescription Opioid Safety Trial (POST) study will be a randomized controlled trial of a brief, tailored ME conversation that incorporates cognitive behavioral strategies to increase pain coping and is aimed at improving patients' opioid safety. The study will recruit 450 patients from primary care clinics at the VA Ann Arbor Healthcare System. Patients with long-term opioid use, defined as treatment for at least 84 days covered within the last 90 days, who are prescribed opioid doses of 20 morphine-equivalent mg/day or greater (an indicator of overdose risk) will be screened and recruited into the study. Participants will then be randomized to either the intervention (n = 225) or an enhanced usual care (EUC) condition (n = 225). Pharmacy records and patient self-report will be assessed at baseline and 3-, 6-, and 12-month follow-ups to measure key outcomes.
The specific aims are:
Aim 1) to examine if patients randomly assigned to a brief opioid safety intervention report reduced overdose risk behaviors (e.g., higher dose, concurrent alcohol use, concurrent other drug/medication use, returning to normal dose after breaks in use) over one year of follow-up compared to patients assigned to equal attention EUC.
Aim 2) to examine if patients randomly assigned to a brief opioid safety intervention have lower total quantities of opioids prescribed (from pharmacy fill records) and aberrant opioid use (e.g., using for reasons other than pain, obtaining opioids from someone other than primary provider) over one year of follow-up compared to patients assigned to equal attention EUC.
The study has two secondary aims: 1) to examine if patients randomly assigned to the brief intervention have fewer non-fatal overdoses and other medication-related adverse events (emergency department visits, over-sedation, injuries), better functioning, and more often store and dispose of opioids safely compared to patients assigned to EUC; and 2) to examine mediators (motivation and self-efficacy) and moderators (OIF/OEF/OND status, baseline mental health) of intervention effects.
- Conditions
- Pain, Drug Overdose, Opioid Use Disorders
- Being tested
- Motivational intervention, Psycho-educational control, Long-term opioid therapy informed consent
- Keywords
- Opioid analgesics, Primary care, Veterans, Motivational interviewing, Cognitive behavioral therapy, Self-efficacy, Behavioral symptoms, Injuries, Opioid Safety
- Medical subject headings
- Pain, Drug Overdose, Opioid-Related Disorders, Behavioral Symptoms, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interventionBehavioural
The intervention session combines elements of motivational enhancement (ME) and cognitive behavioral therapy (CBT). Similar to other ME brief interventions, the intervention content will be covered in a single session. Participants are presented with a variety of risk reduction strategies and strategies for coping with pain that may reduce reliance on opioids for managing pain.
Psycho-educational controlBehavioural
The educational control condition provides educational content related to the biology of pain response and an overview of pain conditions. The overall style is didactic.
Long-term opioid therapy informed consentOther
The Veterans Health Administration instituted a requirement that all patients receiving long-term opioid therapy receive an informed consent process that reviews the risks of opioid therapy. All individuals eligible for this study will meet this definition of long-term opioid therapy. The study therapists for both study arms will deliver the informed consent process during the sessions as part of treatment as usual.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Intervention | Experimental | The intervention session combines elements of motivational enhancement (ME) and cognitive behavioral therapy (CBT) and uses the structure of ME brief interventions. The motivational session is overlaid on the VA long-term opioid therapy informed consent process. Receives: Behavioral: Motivational intervention; Other: Long-term opioid therapy informed consent |
| Enhanced Usual Care | Active comparator | In addition to covering the VHA's long-term OA informed consent process, the enhanced usual care (EUC) condition provides educational content related to the biology of pain response and an overview of pain conditions. The overall style is didactic. This EUC condition will include some information related to risks of opioid use as part of the informed consent and will consequently have sufficient face validity as an intervention on opioid safety to effectively blind participant to randomization. However, the EUC therapist will not use the motivational enhancement approach of discussing strategies for avoiding these risks. It is designed to be equal in length to the motivational intervention. Receives: Behavioral: Psycho-educational control; Other: Long-term opioid therapy informed consent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overdose Risk Behaviors
This scale is a total sum of 9 items assessing participant's self-report of engaging in behavior that increases risk for overdose. Higher scores indicate greater risk for overdose. The range for this measure is 0 to 9 in one assessment.
Measured: 3-, 6-, and 12-months post-baseline
Aberrant Opioid Use
This measure contained 8 self-reported items from the Current Opioid Misuse Measure. Items were assessed on a scale of "never (0)," "rarely (1)," "sometimes (2)," "often (3)," and "very often (4)." A sum score took a range of 0 to 32, with higher numbers indicating more non-medical opioid use.
Measured: 3-, 6-, and 12-months post-baseline
Average Number of Days Prescribed Opioid Use Based on Pharmacy Records
Number of days prescribed opioid use was pulled from pharmacy records. For follow-up periods, times no dose were included to create averages over periods. Patients without medications during their follow-up period were included with a dose of zero.
Measured: 3-, 6-, and 12-months post-baseline
Secondary outcomes (7)
Number of Participants With Non-fatal Overdose Experiences
This scale is the number of overdose experiences as self-reported in the Overdose Experiences questionnaire. This item is a number of participants whom endorsed having experienced an overdose at that time period.
Measured: 3-, 6-, and 12-months post-baseline
Treatment Utilization
Number of visits to the emergency department, for medical, mental health or substance use visits, across VA and non-VA hospitals from the Treatment Service Utilization Questionnaire. The numbers reported are the mean number of visits among those participants that had any emergency department visits at each time point.
Measured: 3-, 6-, and 12-months post-baseline
Other (Non-overdose) Injuries From the Revised Injury Behavior Checklist Questionnaire
This scale is the number of non-overdose injuries assessed through the Revised Injury Behavior Checklist questionnaire, focusing on 4 topics (Injury 1. by violence or by being physically attacked; 2. By falling; 3. By a motor vehicle or by being hit by a moving vehicle while walking; 4. While riding a bicycle, skateboard, or rollerblading). This item is a count of participants who responded that they were injured during any of these types of activities and received treatment.
Measured: 3-, 6-, and 12-months post-baseline
Scores on an Opioid Storage and Disposal Knowledge and Behaviors Questionnaire
This scale assesses safe storage and disposal of prescription opioid medications with 6 items. Items were assessed on a scale of "never (0)," "rarely (1)," "sometimes (2)," "often (3)," and "very often (4)." A sum score took a range of 0 to 24, with higher numbers indicating less safe practices. The sum of the score of the 6 items was used to find the mean scores for those in each arm.
Measured: 3-, 6-, and 12-months post-baseline
Level of Oversedation as an Opioid Side Effect
The level of oversedation as an opioid side effect was assessed using two items from the Pain Treatment Satisfaction Scale looking at side effects of opioid medications (excessive fatigue and drowsiness). Items were assessed on a scale of 0 (did not experience) to 5 (extremely bothered). A sum score ranged from 0 to 10 with a higher score indicating the potential for more oversedation.
Measured: 3-, 6-, and 12-months post-baseline
General Physical and Mental Functioning From Short Form-12 Questionnaire Scores
A modified Veterans RAND 12-item health survey was used to assess general health. One item was scored from 1 (Excellent) to 5 (Poor). Score means were compared at baseline and each follow-up.
Measured: 3-, 6-, and 12-months post-baseline
Pain-specific Disability Score From an Adapted Version of Brief Pain Inventory Questionnaire
This scale is a sub-section of the Brief Pain Inventory that assesses the impact of pain on functioning across 7 different activities. Activities are assessed on a Likert scale from "Does not interfere (0)" to "Completely interferes (10)". BPI pain interference was scored as the mean of the seven interference items, scores range from 0 to 10, with a mean score of 10 (maximum score) indicating a complete interference in all activities.
Measured: 3-, 6-, and 12-months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study start4 Aug 2016
- Primary completion1 Oct 2020
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Amy S Bohnert, PhD MHS BA, Principal investigator, VA Ann Arbor Healthcare System, Ann Arbor, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02464410
- Sponsor's protocol ID
- IIR 13-322
- Acronym
- POST
- Status last verified
- Jul 2023
- First submitted
- 21 May 2015
- Last updated
- 27 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Humphreys K, Shover CL, Andrews CM, Bohnert ASB, Brandeau ML, Caulkins JP, Chen JH, Cuellar MF, Hurd YL, Juurlink DN, Koh HK, Krebs EE, Lembke A, Mackey SC, Larrimore Ouellette L, Suffoletto B, Timko C. Responding to the opioid crisis in North America and beyond: recommendations of the Stanford-Lancet Commission. Lancet. 2022 Feb 5;399(10324):555-604. doi: 10.1016/S0140-6736(21)02252-2. Epub 2022 Feb 2. No abstract available.
PubMed 35122753
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Care Intervention to Reduce Prescription Opioid Overdoses
- ClinicalTrials.gov ID
- NCT02464410
- Acronym / sponsor ID
- POST / IIR 13-322
- Conditions
- Pain, Drug Overdose, Opioid Use Disorders
- Keywords
- Opioid analgesics, Primary care, Veterans, Motivational interviewing, Cognitive behavioral therapy, Self-efficacy, Behavioral symptoms, Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 4 Aug 2016 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 8 Jun 2015 (estimated)
- Results
- Posted 2 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The high rate of adverse events, including overdose, resulting from opioid pain medication use threatens the quality and safety of pain care in the Veterans Health Administration (VHA) and elsewhere and is a critical public health problem in the United States. Pain is a highly common condition among VHA patients, and opioid therapy constitutes a primary mode of pain treatment.
This study seeks to address this issue by conducting a randomized controlled trial of a brief conversation to improve opioid safety among Veteran patients receiving long-term opioid therapy. Veterans receiving opioid therapy for pain in primary care will be recruited and randomized to receive either a single session motivational intervention focused on safe opioid use or an equal attention control condition. The primary hypothesis is that the motivational intervention will improve opioid safety, decrease risk behaviors, aberrant opioid use, and total quantities of opioids prescribed relative to the control condition. Study findings will inform efforts to ensure the safety and well-being of Veteran patients with pain.
Detailed description
Adverse outcomes, including overdose, related to opioid use have increased and represent a significant threat to the safety and quality of VHA pain care as well as a national public health concern. Efforts are underway to change opioid prescribing behavior, but concurrent strategies are needed to address patient behaviors that decrease opioid safety and thus increase opioid overdose risk. Overdoses result from a range of behaviors, including taking more than prescribed, using multiple substances with synergistic effects, and injecting/snorting crushed pills to get high. Factors such as having a mental health condition have been found to increase risk of overdose among Veterans receiving opioids for pain. Given the range of risk behaviors and relevant patient factors, tailored opioid risk reduction strategies are urgently needed. Motivational enhancement (ME) is an evidence-based strategy that uses tailoring to enact behavior change through improving self-efficacy and motivation. Recent VHA initiatives to increase behavioral health providers in primary care, such as Primary Care-Mental Health Integration (PC-MHI), provide a clear opportunity to deliver ME interventions to the many patients treated for long-term pain in primary care. Although the impact of ME on overdose risk behavior is unknown, the use of an ME approach to improve opioid safety and reduce risk behaviors is potentially well-suited to the context of long-term opioid pain care, when total and immediate discontinuation of opioid use is often unfeasible.
The proposed Prescription Opioid Safety Trial (POST) study will be a randomized controlled trial of a brief, tailored ME conversation that incorporates cognitive behavioral strategies to increase pain coping and is aimed at improving patients' opioid safety. The study will recruit 450 patients from primary care clinics at the VA Ann Arbor Healthcare System. Patients with long-term opioid use, defined as treatment for at least 84 days covered within the last 90 days, who are prescribed opioid doses of 20 morphine-equivalent mg/day or greater (an indicator of overdose risk) will be screened and recruited into the study. Participants will then be randomized to either the intervention (n = 225) or an enhanced usual care (EUC) condition (n = 225). Pharmacy records and patient self-report will be assessed at baseline and 3-, 6-, and 12-month follow-ups to measure key outcomes.
The specific aims are:
Aim 1) to examine if patients randomly assigned to a brief opioid safety intervention report reduced overdose risk behaviors (e.g., higher dose, concurrent alcohol use, concurrent other drug/medication use, returning to normal dose after breaks in use) over one year of follow-up compared to patients assigned to equal attention EUC.
Aim 2) to examine if patients randomly assigned to a brief opioid safety intervention have lower total quantities of opioids prescribed (from pharmacy fill records) and aberrant opioid use (e.g., using for reasons other than pain, obtaining opioids from someone other than primary provider) over one year of follow-up compared to patients assigned to equal attention EUC.
The study has two secondary aims: 1) to examine if patients randomly assigned to the brief intervention have fewer non-fatal overdoses and other medication-related adverse events (emergency department visits, over-sedation, injuries), better functioning, and more often store and dispose of opioids safely compared to patients assigned to EUC; and 2) to examine mediators (motivation and self-efficacy) and moderators (OIF/OEF/OND status, baseline mental health) of intervention effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Intervention | Experimental | Behavioral: Motivational intervention, Other: Long-term opioid therapy informed consentThe intervention session combines elements of motivational enhancement (ME) and cognitive behavioral therapy (CBT) and uses the structure of ME brief interventions. The motivational session is overlaid on the VA long-term opioid therapy informed consent process. |
| Enhanced Usual Care | Active comparator | Behavioral: Psycho-educational control, Other: Long-term opioid therapy informed consentIn addition to covering the VHA's long-term OA informed consent process, the enhanced usual care (EUC) condition provides educational content related to the biology of pain response and an overview of pain conditions. The overall style is didactic. This EUC condition will include some information related to risks of opioid use as part of the informed consent and will consequently have sufficient face validity as an intervention on opioid safety to effectively blind participant to randomization. However, the EUC therapist will not use the motivational enhancement approach of discussing strategies for avoiding these risks. It is designed to be equal in length to the motivational intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient at the Ann Arbor VA Medical Center receiving treatment in a primary care clinic
- Currently prescribed 20 morphine-equivalent mg (MEM) per day or more of an opioid
- Received opioid therapy for at least 90 days
- 18 years of age or older
Key exclusion criteria (6 listed)
- Plans to stop opioids or reduce dose to below 20 MEM/day in the next 6 months
- Use of fentanyl, due to the difficulty in determining morphine equivalency
- A terminal cancer diagnosis
- Acute suicidality requiring immediate treatment
- Moderately severe cognitive impairment
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 |
|---|---|---|
| Motivational interventionThe intervention session combines elements of motivational enhancement (ME) and cognitive behavioral therapy (CBT). Similar to other ME brief interventions, the intervention content will be covered in a single session. Participants are presented with a variety of risk reduction strategies and strategies for coping with pain that may reduce reliance on opioids for managing pain. | Behavioural | Motivational Intervention |
| Psycho-educational controlThe educational control condition provides educational content related to the biology of pain response and an overview of pain conditions. The overall style is didactic. | Behavioural | Enhanced Usual Care |
| Long-term opioid therapy informed consentThe Veterans Health Administration instituted a requirement that all patients receiving long-term opioid therapy receive an informed consent process that reviews the risks of opioid therapy. All individuals eligible for this study will meet this definition of long-term opioid therapy. The study therapists for both study arms will deliver the informed consent process during the sessions as part of treatment as usual. | Other | Enhanced Usual Care, Motivational Intervention |
Primary outcome
Overdose Risk Behaviors
Time frame: 3-, 6-, and 12-months post-baseline
This scale is a total sum of 9 items assessing participant's self-report of engaging in behavior that increases risk for overdose. Higher scores indicate greater risk for overdose. The range for this measure is 0 to 9 in one assessment.
Aberrant Opioid Use
Time frame: 3-, 6-, and 12-months post-baseline
This measure contained 8 self-reported items from the Current Opioid Misuse Measure. Items were assessed on a scale of "never (0)," "rarely (1)," "sometimes (2)," "often (3)," and "very often (4)." A sum score took a range of 0 to 32, with higher numbers indicating more non-medical opioid use.
Average Number of Days Prescribed Opioid Use Based on Pharmacy Records
Time frame: 3-, 6-, and 12-months post-baseline
Number of days prescribed opioid use was pulled from pharmacy records. For follow-up periods, times no dose were included to create averages over periods. Patients without medications during their follow-up period were included with a dose of zero.
7 secondary outcomes
Number of Participants With Non-fatal Overdose Experiences
Time frame: 3-, 6-, and 12-months post-baseline
Treatment Utilization
Time frame: 3-, 6-, and 12-months post-baseline
Other (Non-overdose) Injuries From the Revised Injury Behavior Checklist Questionnaire
Time frame: 3-, 6-, and 12-months post-baseline
Scores on an Opioid Storage and Disposal Knowledge and Behaviors Questionnaire
Time frame: 3-, 6-, and 12-months post-baseline
Level of Oversedation as an Opioid Side Effect
Time frame: 3-, 6-, and 12-months post-baseline
General Physical and Mental Functioning From Short Form-12 Questionnaire Scores
Time frame: 3-, 6-, and 12-months post-baseline
Pain-specific Disability Score From an Adapted Version of Brief Pain Inventory Questionnaire
Time frame: 3-, 6-, and 12-months post-baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 35122753Humphreys K, Shover CL, Andrews CM, Bohnert ASB, Brandeau ML, Caulkins JP, Chen JH, Cuellar MF, Hurd YL, Juurlink DN, Koh HK, Krebs EE, Lembke A, Mackey SC, Larrimore Ouellette L, Suffoletto B, Timko C. Responding to the opioid crisis in North America and beyond: recommendations of the Stanford-Lancet Commission. Lancet. 2022 Feb 5;399(10324):555-604. doi: 10.1016/S0140-6736(21)02252-2. Epub 2022 Feb 2. No abstract available.
- Individual participant dataSharing planned: No
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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.
Amy S Bohnert, PhD MHS BA principal investigator
VA Ann Arbor Healthcare System, Ann Arbor, MI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational intervention and Long-term opioid therapy informed consent in people with Pain and Drug Overdose, run by VA Office of Research and Development at 1 site 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 4 inclusion and 6 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 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 2 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overdose Risk Behaviors (time frame: 3-, 6-, and 12-months post-baseline). The study lists 3 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 NCT02464410, 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 27 Jul 2023; AzTrials last refreshed its copy on 6 Nov 2026.