Opioid UseNCT03999450
Preventing Premature Death in Patients With Serious Opioid-related Infection
A study testing brief motivational intervention (BMI) and cognitive behavioral therapy in people with Opioid Use, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to test the efficacy of a combination of motivational interventions and a brief therapy session to increase the adherence to medication-assisted treatment (MAT) for opioids. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use
- What is being tested?
- brief motivational intervention (BMI) and cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2019to 31 May 2020
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Willing to provide contact information (e.g., email, phone, address)
- Presence of SORI, including endocarditis, osteomyelitis, septic arthritis, epidural abscess, or serious bacteremia
- Hospital length of stay estimated at > 3 weeks
- Admitted to URMC and seen by the Toxicology Consult Team. Providers will be informed of inclusion/exclusion requirements so that they can make an informed decision about whether a patient may be approached.
Who cannot join
- Non-English speaking
- Unwilling to provide informed consent; unable to provide informed consent or participate in study procedures due to lack of comprehension, medical barriers (e.g., intubated), or behavioral (e.g., violence) or severe psychiatric problems (e.g., florid psychosis). Capacity to provide informed consent will be determined by their treatment team or other provider consult team as appropriate. This serves a dual function of both basing consent capacity on the most accurate and current medical information, as well as keeping their treatment team informed of any research involvement of their patient.
- Note that patients may be ineligible initially but become eligible due to stabilization during hospitalization, at which point we would then proceed as usual with the identification and recruitment process. We will seek to recruit every SORI admission who meets eligibility criteria within the recruitment timeframe.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Preventing Premature Death Among Hospital Patients With Serious Opioid-Related Infection (SORI): A Phase 1 Pilot Study
The purpose of this study is to test the efficacy of a combination of motivational interventions and a brief therapy session to increase the adherence to medication-assisted treatment (MAT) for opioids.
Read the detailed description
We will recruit 30 SORI inpatients ages 18-plus admitted to the University of Rochester Medical Center (URMC). We will administer a battery of validated assessments of substance use, overdose history and risk, opioid-related infection, and suicidal behavior at baseline and approximately 2- and 4-week follow-ups. We will assess both forms of overdose (unintentional, intentional - i.e., suicidal behavior) because each is common in intravenous drug users and they require systematic assessment to disentangle. All recruited individuals will receive one-to-three MI sessions as they begin the MAT that is part of standard hospital care. Patients will be offered computer-based CBT, which they will complete on the unit at their convenience. The CBT program records duration of use of the treatment modules, enabling us to track patients' level of CBT treatment participation. Patient-completed intervention feedback forms and treatment completion will be examined after 15 subjects have participated. Based on this feedback, we will pilot an adapted (MI plus CBT) treatment manual, obtaining additional feedback on acceptability. We will assess psychopathy, a constellation of stable traits and potentially important moderator of treatment effects, at baseline. We will assess potential mediators (i.e., motivation to change, self-regulation) using validated measures at baseline and at approximately 2- and 4-weeks post-discharge.
- Conditions
- Opioid Use
- Being tested
- brief motivational intervention (BMI), cognitive behavioral therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brief motivational intervention (BMI)Behavioural
The intervention typically takes 45 minutes to administer and is designed to enhance motivation to change and includes the following components: establishing rapport, asking permission to discuss substance use and providing feedback regarding the substance use assessment, exploring personal consequences of drug use, eliciting the gap between real and desired quality of life, and discussing readiness to change. The therapist then negotiates a written action plan, during which the subject is supported with empathy and verbal reinforcement.
cognitive behavioral therapyBehavioural
This evidence-based, online, Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT) program covers six lessons: 1) changing patterns of use, 2) coping with craving, 3) refusing drugs, 4) problem-solving skills, 5) changing drug-related thoughts, and 6) improving decision-making. The program is designed to be user-friendly and includes videotaped instructions and examples, interactive assessments, and practice exercises.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral intervention | Experimental | Patients admitted to Strong Hospital with opioid use will be given 1 to 3 brief motivational interventions and computer based cognitive behavioral therapy Receives: Behavioral: brief motivational intervention (BMI); Behavioral: cognitive behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who completed the week 4 follow up assessments
The percentage of participants who completed the week 4 follow up assessments.
Measured: week 4
Percentage of participants who report intervention acceptability
Written and verbal feedback will be collected from participants.
Measured: week 4
Change in mean readiness
A readiness ruler with a scale of 1- 10 where higher numbers indicate better health outcomes will be used to to assess motivation to change illicit substance use.
Measured: baseline to 2 weeks
Change in mean self-regulation
The Self-Regulation Questionnaire is a 63 item questionnaire with each question rated at a 5-point likert scale.
> 239 High (intact) self-regulation capacity (top quartile) 214-238 Intermediate (moderate) self-regulation capacity (middle quartiles) < 213 Low (impaired) self-regulation capacity (bottom quartile)
Measured: baseline to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start8 Oct 2019
- Primary completion31 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Marc Swogger, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03999450
- Sponsor's protocol ID
- RSRB00003696
- Status last verified
- Jul 2020
- First submitted
- 5 Jun 2019
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Premature Death Among Hospital Patients With Serious Opioid-Related Infection (SORI): A Phase 1 Pilot Study
- ClinicalTrials.gov ID
- NCT03999450
- Acronym / sponsor ID
- RSRB00003696
- Conditions
- Opioid Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 26 Jun 2019 (actual)
- 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 test the efficacy of a combination of motivational interventions and a brief therapy session to increase the adherence to medication-assisted treatment (MAT) for opioids.
Detailed description
We will recruit 30 SORI inpatients ages 18-plus admitted to the University of Rochester Medical Center (URMC). We will administer a battery of validated assessments of substance use, overdose history and risk, opioid-related infection, and suicidal behavior at baseline and approximately 2- and 4-week follow-ups. We will assess both forms of overdose (unintentional, intentional - i.e., suicidal behavior) because each is common in intravenous drug users and they require systematic assessment to disentangle. All recruited individuals will receive one-to-three MI sessions as they begin the MAT that is part of standard hospital care. Patients will be offered computer-based CBT, which they will complete on the unit at their convenience. The CBT program records duration of use of the treatment modules, enabling us to track patients' level of CBT treatment participation. Patient-completed intervention feedback forms and treatment completion will be examined after 15 subjects have participated. Based on this feedback, we will pilot an adapted (MI plus CBT) treatment manual, obtaining additional feedback on acceptability. We will assess psychopathy, a constellation of stable traits and potentially important moderator of treatment effects, at baseline. We will assess potential mediators (i.e., motivation to change, self-regulation) using validated measures at baseline and at approximately 2- and 4-weeks post-discharge.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behavioral intervention | Experimental | Behavioral: brief motivational intervention (BMI), Behavioral: cognitive behavioral therapyPatients admitted to Strong Hospital with opioid use will be given 1 to 3 brief motivational interventions and computer based cognitive behavioral therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 or older
- Willing to provide contact information (e.g., email, phone, address)
- Presence of SORI, including endocarditis, osteomyelitis, septic arthritis, epidural abscess, or serious bacteremia
- Hospital length of stay estimated at > 3 weeks
- Admitted to URMC and seen by the Toxicology Consult Team. Providers will be informed of inclusion/exclusion requirements so that they can make an informed decision about whether a patient may be approached.
Key exclusion criteria (3 listed)
- Non-English speaking
- Unwilling to provide informed consent; unable to provide informed consent or participate in study procedures due to lack of comprehension, medical barriers (e.g., intubated), or behavioral (e.g., violence) or severe psychiatric problems (e.g., florid psychosis). Capacity to provide informed consent will be determined by their treatment team or other provider consult team as appropriate. This serves a dual function of both basing consent capacity on the most accurate and current medical information, as well as keeping their treatment team informed of any research involvement of their patient.
- Note that patients may be ineligible initially but become eligible due to stabilization during hospitalization, at which point we would then proceed as usual with the identification and recruitment process. We will seek to recruit every SORI admission who meets eligibility criteria within the recruitment timeframe.
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 |
|---|---|---|
| brief motivational intervention (BMI)The intervention typically takes 45 minutes to administer and is designed to enhance motivation to change and includes the following components: establishing rapport, asking permission to discuss substance use and providing feedback regarding the substance use assessment, exploring personal consequences of drug use, eliciting the gap between real and desired quality of life, and discussing readiness to change. The therapist then negotiates a written action plan, during which the subject is supported with empathy and verbal reinforcement. | Behavioural | Behavioral intervention |
| cognitive behavioral therapyThis evidence-based, online, Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT) program covers six lessons: 1) changing patterns of use, 2) coping with craving, 3) refusing drugs, 4) problem-solving skills, 5) changing drug-related thoughts, and 6) improving decision-making. The program is designed to be user-friendly and includes videotaped instructions and examples, interactive assessments, and practice exercises. | Behavioural | Behavioral intervention |
Primary outcome
Percentage of participants who completed the week 4 follow up assessments
Time frame: week 4
The percentage of participants who completed the week 4 follow up assessments.
Percentage of participants who report intervention acceptability
Time frame: week 4
Written and verbal feedback will be collected from participants.
Change in mean readiness
Time frame: baseline to 2 weeks
A readiness ruler with a scale of 1- 10 where higher numbers indicate better health outcomes will be used to to assess motivation to change illicit substance use.
Change in mean self-regulation
Time frame: baseline to 2 weeks
The Self-Regulation Questionnaire is a 63 item questionnaire with each question rated at a 5-point likert scale. > 239 High (intact) self-regulation capacity (top quartile) 214-238 Intermediate (moderate) self-regulation capacity (middle quartiles) < 213 Low (impaired) self-regulation capacity (bottom quartile)
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 28 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing brief motivational intervention (BMI) and cognitive behavioral therapy in people with Opioid Use, run by University of Rochester 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 5 inclusion and 3 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 28 Jul 2020. 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?
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?
Percentage of participants who completed the week 4 follow up assessments (time frame: week 4). 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?
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 28 Jul 2020.