An interventional study of Motivational intervention and Psycho-educational control in Pain, Drug Overdose and Opioid Use Disorders, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-27.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
Among 48 studies in Pain by VA Office of Research and Development — 13 open to participants now, 15 under way, 1 of them phase 3. Pain · VA Office of Research and Development.
Among the 48 studies in Pain by VA Office of Research and Development, this one is the 7th largest by enrollment of the 46 interventional ones that give a count, is one of 2 that started in 2016, is one of 36 with no phase, and was the 18th registered.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
Browse Pain studies →13 of the 48 studies in Pain by VA Office of Research and Development are open now, in 1 country. Recruiting first, the newest first:
VA Office of Research and Development · Sites in United States
VA Office of Research and Development · Sites in United States
VA Office of Research and Development · Sites in United States
VA Office of Research and Development · Sites in United States
VA Office of Research and Development · Sites in United States
By country, each count listing its studies:
Of the 929 Pain studies recruiting now, 384 (41%) set no upper age limit and 434 (47%) stop at 75 or younger; 146 take children under 18; 222 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
48 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 2 started in 2016.
This study's enrollment of 299 is above the median of 66 across 8,493 interventional studies indexed under Pain.
Median enrollment 194 across the 46 interventional studies, 10 across the 2 observational. Of the 33 that completed or were terminated, 29 (88%) have results posted.
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VA Office of Research and Development is the lead sponsor of 1,771 studies on the registry; 392 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.
3 of the studies in Pain by VA Office of Research and Development that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05563792VA Office of Research and DevelopmentOptions for Pain Management Using Nonpharmacological Strategies | 2027-01-31 |
| NCT04003285VA Office of Research and DevelopmentAllopregnanolone in Chronic Complex Traumatic Brain Injury | 2027-06-01 |
| NCT04142177VA Office of Research and DevelopmentSequential and Comparative Evaluation of Pain Treatment Effectiveness Response | 2027-06-30 |
Among the 48 studies in Pain by VA Office of Research and Development, from their registry updates:
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Motivational intervention · Other: Long-term opioid therapy informed consent
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.
Behavioral: Psycho-educational control · Other: Long-term opioid therapy informed consent
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.
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 3-, 6-, and 12-months post-baseline
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3-, 6-, and 12-months post-baseline
| Milestone | Motivational Intervention | Enhanced Usual Care |
|---|---|---|
| Started | 147 | 152 |
| 3-month follow-up | 137 | 138 |
| 6-month follow-up | 132 | 140 |
| 12-month follow-up | 125 | 136 |
| Completed | 125 | 136 |
| Not completed | 22 | 16 |
| Withdrew: Death | 3 | 4 |
| Withdrew: Lost to follow-up | 7 | 9 |
| Withdrew: Withdrawal by subject | 12 | 3 |
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.
| score on a scale | Motivational Intervention | Enhanced Usual Care |
|---|---|---|
| 3-Month Follow-up | 1.31 ± 1.14 | 1.21 ± 1.09 |
| 6-Month Follow-up | 1.45 ± 1.20 | 1.25 ± 1.29 |
| 12-Month Follow-up | 1.38 ± 1.29 | 1.07 ± 1.05 |
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.
| score on a scale | Motivational Intervention | Enhanced Usual Care |
|---|---|---|
| 3-Month Follow-up | 2.95 ± 3.04 | 2.51 ± 2.74 |
| 6-Month Follow-up | 2.87 ± 3.06 | 2.68 ± 3.11 |
| 12-Month Follow-up | 2.80 ± 3.08 | 2.73 ± 3.35 |
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.
| Days of Prescribed Opioid Use | Motivational Intervention | Enhanced Usual Care |
|---|---|---|
| 3-Month Follow-up | 48.23 ± 38.97 | 45.81 ± 41.06 |
| 6-Month Follow-up | 44.75 ± 38.70 | 42.54 ± 41.08 |
| 12-Month Follow-up | 42.19 ± 38.92 | 37.56 ± 38.83 |
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.
| participants with OD | Motivational Intervention | Enhanced Usual Care |
|---|---|---|
| 3-Month Follow-up | 1 | 0 |
| 6-Month Follow-up | 2 | 1 |
| 12-Month Follow-up | 0 | 1 |
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.
| Visits to the Emergency Dept | Motivational Intervention | Enhanced Usual Care |
|---|---|---|
| 3-Month Follow-up | 1.50 ± 0.84 | 1.81 ± 1.24 |
| 6-Month Follow-up | 1.61 ± 1.77 | 2.11 ± 2.31 |
| 12-Month Follow-up | 2.20 ± 3.27 | 2.04 ± 1.85 |
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.
| Participants | Motivational Intervention | Enhanced Usual Care |
|---|---|---|
| 3-Month Follow-up | 5 | 4 |
| 6-Month Follow-up | 4 | 5 |
| 12-Month Follow-up | 11 | 4 |
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.
| score on a scale | Motivational Intervention | Enhanced Usual Care |
|---|---|---|
| 3-Month Follow-up | 0.95 ± 1.47 | 0.68 ± 1.28 |
| 6-Month Follow-up | 1.07 ± 1.63 | 0.69 ± 1.37 |
| 12-Month Follow-up | 1.13 ± 1.82 | 0.76 ± 1.45 |
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.
| score on a scale | Motivational Intervention | Enhanced Usual Care |
|---|---|---|
| 3-Month Follow-up | 1.66 ± 2.20 | 1.96 ± 2.59 |
| 6-Month Follow-up | 1.57 ± 2.05 | 2.08 ± 2.55 |
| 12-Month Follow-up | 2.36 ± 2.46 | 2.25 ± 2.59 |
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.
| score on a scale | Motivational Intervention | Enhanced Usual Care |
|---|---|---|
| 3-Month Follow-up | 3.57 ± 0.89 | 3.70 ± 0.95 |
| 6-Month Follow-up | 3.63 ± 0.94 | 3.76 ± 0.99 |
| 12-Month Follow-up | 3.71 ± 0.81 | 3.79 ± 0.93 |
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.
| score on a scale | Motivational Intervention | Enhanced Usual Care |
|---|---|---|
| 3-Month Follow-up | 4.86 ± 2.87 | 5.10 ± 4.64 |
| 6-Month Follow-up | 4.89 ± 2.66 | 5.16 ± 2.88 |
| 12-Month Follow-up | 4.89 ± 4.40 | 5.41 ± 2.51 |
Collected over Collected over 12 months post-baseline assessment. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Motivational Intervention | 3/147 (2%) | 0/147 (0%) | 0/147 (0%) |
| Enhanced Usual Care | 4/152 (2.6%) | 0/152 (0%) | 0/152 (0%) |
| Age, Categorical(Participants) | Motivational Intervention | Enhanced Usual Care | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 68 | 87 | 155 |
| >=65 years | 79 | 65 | 144 |
| Sex: Female, Male(Participants) | Motivational Intervention | Enhanced Usual Care | Total |
|---|---|---|---|
| Female | 15 | 8 | 23 |
| Male | 132 | 144 | 276 |
| Ethnicity (NIH/OMB)(Participants) | Motivational Intervention | Enhanced Usual Care | Total |
|---|---|---|---|
| Hispanic or Latino | 6 | 2 | 8 |
| Not Hispanic or Latino | 141 | 150 | 291 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Motivational Intervention | Enhanced Usual Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 4 | 5 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 11 | 12 | 23 |
| White | 125 | 125 | 250 |
| More than one race | 6 | 6 | 12 |
| Unknown or Not Reported | 4 | 4 | 8 |
| Region of Enrollment(Participants) | Motivational Intervention | Enhanced Usual Care | Total |
|---|---|---|---|
| United States | 147 | 152 | 299 |
| Overdose risk behaviors(units on a scale) | Motivational Intervention | Enhanced Usual Care | Total |
|---|---|---|---|
| Mean | 1.63 ± 1.16 | 1.75 ± 1.26 | 1.69 ± 1.21 |
| Aberrant opioid use(units on a scale) | Motivational Intervention | Enhanced Usual Care | Total |
|---|---|---|---|
| Mean | 4.16 ± 3.58 | 3.77 ± 3.43 | 3.96 ± 3.51 |
| Average number of days prescribed opioid use based on pharmacy records(Days of Prescribed Opioid Use) | Motivational Intervention | Enhanced Usual Care | Total |
|---|---|---|---|
| Mean | 51.57 ± 39.75 | 47.54 ± 38.96 | 49.52 ± 39.34 |
7 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Aug 2016 to primary completion in Oct 2020, 49 months.
Results were first posted in Sep 2022, 1 year 11 months after primary completion.
Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's 49 months is above that.
Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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