Opioid MisuseNCT03149718
Community Pharmacists and Opioid Misuse
A study testing Brief Intervention Medication Therapy Management and Standard Medication Counseling (SMC) in people with Opioid Misuse, run by University of Utah at 2 sites in United States.
Trial summary
Opioid medication misuse and overdose have reached epidemic proportions in the US. Community pharmacy is a potentially valuable resource for addressing opioid medication misuse. This study will manualize and establish the feasibility, acceptability, and clinical effect of a community pharmacist-led intervention aimed… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Misuse
- What is being tested?
- Brief Intervention Medication Therapy Management and Standard Medication Counseling (SMC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Sep 2017to 1 Jun 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Opioid Misuse
- -≥18 years
- English speaking
Who cannot join
- Are pregnant (given potential pre/post-natal opioid use complications among pregnant women/offspring)
- Cannot provide collateral contact information for ≥2 contact persons (to ensure consistent contact/follow up)
- Do not have a reliable landline or mobile phone to be contacted by study staff
- Are only filling buprenorphine (given some formulations are not indicated for pain)
- Plan to leave the area for an extended period of time in the next 3 months
- Have had a psychotic and/or manic episode in the last 30 days
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Falk Pharmacy
Pittsburgh, Pennsylvania, 15213
Medicine Shoppe
Somerset, Pennsylvania, 15501
About this study
Official title: Prescription Opioid Misuse: Pharmacist-Delivered Intervention at Point of Service
Opioid medication misuse and overdose have reached epidemic proportions in the US. Community pharmacy is a potentially valuable resource for addressing opioid medication misuse. This study will manualize and establish the feasibility, acceptability, and clinical effect of a community pharmacist-led intervention aimed at: improving opioid mediation regimen adherence, eliminating misuse, connecting patients to additional care, and safeguarding against overdose.
Read the detailed description
The current small scale single-blinded randomized controlled study will build on our preliminary studies by manualizing and examining the feasibility, acceptability, and clinical effect for the Brief Intervention Medication Therapy Management (BI-MTM) model. BI-MTM is a multicomponent community pharmacy-based intervention. BI-MTM is designed to: (1) promote opioid medication regimen adherence, (2) reduce opioid medication misuse, (3) connect participants with patient navigation (a chronic condition care model) to increase self-management of health conditions that increase risk for misuse, and (4) provide naloxone rescue training referrals. Patients will be screened across 14 months for opioid medication misuse in an urban community pharmacy affiliated with a major medical system. Patients positive for misuse will be randomly assigned to BI-MTM (n=23) or Standard Medication Counseling (n=23). Standard Medication Counseling is the Centers for Medicaid and Medicare Services requirement for pharmacists in the US wherein pharmacy patients filling prescriptions receive information and opt-in counseling. This study will demonstrate feasibility and acceptability of BI-MTM for community pharmacy patients who misuse their opioid medications for future intervention implementation in a fully powered randomized trial. This study will also generate preliminary data regarding opioid medication misuse elimination and increases in participant self-management activation for comorbid health conditions that increase risk for misuse.
- Conditions
- Opioid Misuse
- Being tested
- Brief Intervention Medication Therapy Management, Standard Medication Counseling (SMC)
- Keywords
- Pharmacy, Intervention, Medication Adherence
- Medical subject headings
- Opioid-Related Disorders, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Intervention Medication Therapy ManagementBehavioural
BI-MTM is designed to: (1) eliminate opioid medication misuse, (2) promote opioid regimen adherence, (3) connect participants with Patient Navigation to increase patient self-management activation for health conditions that increase risk for misuse (Patient Navigation is an evidence-based chronic care intervention), and (4) provide naloxone rescue training referrals.
Standard Medication Counseling (SMC)Behavioural
Standard Medication Counseling (SMC; n=23; i.e., treatment-as-usual condition). Standard Medication Counseling is the Centers for Medicaid and Medicare Services requirement for pharmacists in the US wherein pharmacy patients filling prescriptions receive information and opt-in counseling.
| Study group | Role | What they receive |
|---|---|---|
| SMC (n=23) | Active comparator | Standard Medication Counseling. Receives: Behavioral: Standard Medication Counseling (SMC) |
| BI-MTM (n=23) | Experimental | Brief Intervention Medication Therapy Management. Receives: Behavioral: Brief Intervention Medication Therapy Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention feasibility
Intervention feasibility will be established through delivery of all BI-MTM components to 85% of BI-MTM recipients.
Measured: Month 21 of Study
Intervention acceptability
Intervention acceptability will be demonstrated though qualitative interviews.
Measured: Month 21 of Study
Secondary outcomes (2)
Opioid Misuse
Opioid misuse will be demonstrated by the Prescription Opioid Misuse Index (POMI).
Measured: Month 21 of Study
Patient Self-Management
Patient self-management activation misuse than will be captured by the Patient Activation Measure.
Measured: Month 21 of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start15 Sep 2017
- Primary completion27 Mar 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid MisuseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Jerry Cochran, University of Utah
- Investigators
- Gerald Cochran, Ph.D., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03149718
- Sponsor's protocol ID
- PRO17010410
- Other IDs
- R21DA043735
- Status last verified
- Oct 2019
- First submitted
- 5 May 2017
- Last updated
- 14 Oct 2019
- Results posted
- 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 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prescription Opioid Misuse: Pharmacist-Delivered Intervention at Point of Service
- ClinicalTrials.gov ID
- NCT03149718
- Acronym / sponsor ID
- PRO17010410
- Conditions
- Opioid Misuse
- Keywords
- Pharmacy, Intervention, Medication Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 27 Mar 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 11 May 2017 (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.
Opioid medication misuse and overdose have reached epidemic proportions in the US. Community pharmacy is a potentially valuable resource for addressing opioid medication misuse. This study will manualize and establish the feasibility, acceptability, and clinical effect of a community pharmacist-led intervention aimed at: improving opioid mediation regimen adherence, eliminating misuse, connecting patients to additional care, and safeguarding against overdose.
Detailed description
The current small scale single-blinded randomized controlled study will build on our preliminary studies by manualizing and examining the feasibility, acceptability, and clinical effect for the Brief Intervention Medication Therapy Management (BI-MTM) model. BI-MTM is a multicomponent community pharmacy-based intervention. BI-MTM is designed to: (1) promote opioid medication regimen adherence, (2) reduce opioid medication misuse, (3) connect participants with patient navigation (a chronic condition care model) to increase self-management of health conditions that increase risk for misuse, and (4) provide naloxone rescue training referrals. Patients will be screened across 14 months for opioid medication misuse in an urban community pharmacy affiliated with a major medical system. Patients positive for misuse will be randomly assigned to BI-MTM (n=23) or Standard Medication Counseling (n=23). Standard Medication Counseling is the Centers for Medicaid and Medicare Services requirement for pharmacists in the US wherein pharmacy patients filling prescriptions receive information and opt-in counseling. This study will demonstrate feasibility and acceptability of BI-MTM for community pharmacy patients who misuse their opioid medications for future intervention implementation in a fully powered randomized trial. This study will also generate preliminary data regarding opioid medication misuse elimination and increases in participant self-management activation for comorbid health conditions that increase risk for misuse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMC (n=23) | Active comparator | Behavioral: Standard Medication Counseling (SMC)Standard Medication Counseling. |
| BI-MTM (n=23) | Experimental | Behavioral: Brief Intervention Medication Therapy ManagementBrief Intervention Medication Therapy Management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Opioid Misuse
- -≥18 years
- English speaking
Key exclusion criteria (6 listed)
- Are pregnant (given potential pre/post-natal opioid use complications among pregnant women/offspring)
- Cannot provide collateral contact information for ≥2 contact persons (to ensure consistent contact/follow up)
- Do not have a reliable landline or mobile phone to be contacted by study staff
- Are only filling buprenorphine (given some formulations are not indicated for pain)
- Plan to leave the area for an extended period of time in the next 3 months
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 Intervention Medication Therapy ManagementBI-MTM is designed to: (1) eliminate opioid medication misuse, (2) promote opioid regimen adherence, (3) connect participants with Patient Navigation to increase patient self-management activation for health conditions that increase risk for misuse (Patient Navigation is an evidence-based chronic care intervention), and (4) provide naloxone rescue training referrals. | Behavioural | BI-MTM (n=23) |
| Standard Medication Counseling (SMC)Standard Medication Counseling (SMC; n=23; i.e., treatment-as-usual condition). Standard Medication Counseling is the Centers for Medicaid and Medicare Services requirement for pharmacists in the US wherein pharmacy patients filling prescriptions receive information and opt-in counseling. | Behavioural | SMC (n=23) |
Primary outcome
Intervention feasibility
Time frame: Month 21 of Study
Intervention feasibility will be established through delivery of all BI-MTM components to 85% of BI-MTM recipients.
Intervention acceptability
Time frame: Month 21 of Study
Intervention acceptability will be demonstrated though qualitative interviews.
2 secondary outcomes
Opioid Misuse
Time frame: Month 21 of Study
Patient Self-Management
Time frame: Month 21 of Study
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 14 Oct 2019.
- 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.
Gerald Cochran, Ph.D. principal investigator
University of Utah
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Intervention Medication Therapy Management and Standard Medication Counseling (SMC) in people with Opioid Misuse, run by University of Utah 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 3 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 14 Oct 2019. 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?
Intervention feasibility (time frame: Month 21 of Study). The study lists 2 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 14 Oct 2019.