Opioid MisuseHOPENCT05141266
Healthy Opioid Prescription Engagement
A study testing Patient Navigation and Standard Medication Counseling (SMC) in people with Opioid Misuse and Opioid-Related Disorders, run by Jerry Cochran at 1 site in United States.
Trial summary
This study is a randomized controlled trial across 14 community pharmacies to test the efficacy of the Brief Intervention-Medication Therapy Management intervention (BI-MTM). The establishment of the BI-MTM model will result in a major impact for addressing the opioid epidemic, preventing opioid use disorder and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Misuse, Opioid-Related Disorders, Pharmacist-Patient Relations
- What is being tested?
- Patient Navigation 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
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2021to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adult (≥18 years)
- English speaking
- Not receiving cancer treatment
- Who have a positive opioid misuse screen on the POMI will be eligible to learn about this study
Who cannot join
- Are pregnant (given potential pre/post-natal opioid use complications among pregnant women/offspring
- Can-not provide collateral contact information for ≥2 contact persons (to ensure consistent contact/follow up)
- Do not have a reliable land line or mobile phone to be contacted by study staff
- Are filling only buprenorphine (given some formulations are not indicated for pain)
- Plan to leave the area for an extended period of time in the next 6 months
- Have had a psychotic and/or manic episode in the last 30 days (before consent, patients will be asked to screen for psychosis
- Do not provide permission to access their state prescription drug monitoring data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Healthy Opioid Prescription Engagement 2.0
This study is a randomized controlled trial across 14 community pharmacies to test the efficacy of the Brief Intervention-Medication Therapy Management intervention (BI-MTM). The establishment of the BI-MTM model will result in a major impact for addressing the opioid epidemic, preventing opioid use disorder and overdose, and safeguarding patient health in a novel community-based service setting.
Read the detailed description
This study examines a community pharmacy-based intervention to reduce opioid medication misuse. Despite a recent national decline in opioid prescribing, 10.3 million Americans in 2018 reported misusing a prescribed opioid, and within this population, >36% of those who misused obtained the opioid medication by filling a prescription. The point of medication dispensing, namely, the community pharmacy, is an untapped resource to address prescription opioid misuse-especially when considering the >60,000 pharmacies employing >170,000 pharmacists in the US. This study aims to conduct a fully-powered RCT of the BI-MTM intervention in community pharmacy settings that will accomplish 3 Specific Aims. The first Aim will demonstrate the pharmacist-led BI-MTM intervention is superior to standard medication counseling (SMC) for mitigating opioid medication misuse. This will be accomplished by conducting a powered single-blinded randomized trial to test the efficacy of BI-MTM (n=175) vs. SMC (n=175). Participants will be screened/recruited for eligibility at point of dispensing in 14 community pharmacies in Utah, a high opioid prescribing and opioid-adverse event state. Participants will be assessed at baseline, 2, and 6 months for opioid medication misuse. Participant-level state prescription drug monitoring data will also be linked with patient outcomes to assess objective changes in medication misuse behaviors (e.g., early refills and doctor/pharmacy shopping). The second Aim will identify the pathway by which BI-MTM results in improvements for depression, pain, and subsequently opioid misuse. To accomplish this, a path analysis will assess relationships of BI-MTM: (1) on depression, pain, and misuse, (2) depression on misuse, and (3) pain on misuse. The final Aim will explore latent transitions of baseline to post-intervention misuse classes by intervention group. This will be accomplished by using mixture modeling, specifically multi-group latent transition analysis. The observed misuse indicators will be used to estimate latent class transitions across time, grouping by treatment condition and adjusting for baseline covariates. Completing SA1- 3 advance the understanding of BI-MTM efficacy and set the stage for a national multisite trial.
- Being tested
- Patient Navigation, Standard Medication Counseling (SMC)
- Keywords
- Community Pharmacies, Patient Navigation, Opioid intervention
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient NavigationBehavioural
PN involves 8 weekly telephonic sessions lasting 30-45 minutes (telephonic to support lower-costs/sustainability). In session 1, the navigator reviews with the participant a report of scores from the baseline assessment to understand the participant's current health needs/challenges; session 1 also involves development of therapeutic alliance/rapport and goal setting. Sessions 2-4 focus on goal setting and identifying barriers and problem resolutions. The navigator elicits motivation and discusses this in context of readiness to change heath behavior and self-management skills. Sessions 2-4 also involve navigators supporting/assisting patients to fill out paperwork and enroll in needed social services and/or mental/behavioral/physical healthcare, including but not limited to primary care. Sessions 5-7 focus on encouraging and reinforcing treatment adherence, review-ing and identifying other care needs, and offering linkages to service providers as applicable
Standard Medication Counseling (SMC)Other
SMC participants receive a single medication information/counseling session delivered by a University of Utah pharmacist to: (1) offer counseling, (2) document counseling was offered, (3) offer a counseling process for patients not present (not applicable to this study given all patients must screen in person), and (4) discuss generic substitution.
| Study group | Role | What they receive |
|---|---|---|
| Brief Intervention Medication Therapy Management (BI-MTM) | Experimental | Brief Intervention Medication Therapy Management (BI-MTM) is the overarching model made up of 4 evidence-based components: Medication Therapy Management (MTM); Screening, Brief Intervention, and Referral to Treatment (SBIRT); naloxone dispensing, and Patient Navigation (PN). Each component is sequentially delivered within the model and addresses a critical aspect of opioid medication misuse and risk. The pharmacy-based portion of BI-MTM (MTM+SBIRT+naloxone) will be delivered by a PharmD level pharmacist, and PN will be delivered by a bachelor's level interventionist. Receives: Behavioral: Patient Navigation |
| Standard of Care | Other | Standard of Care is the treatment as usual condition, which follows federal and Utah state pharmacy requirements for pharmacists where in patients filling prescriptions receive information and opt-in counseling. Specifically, SMC in Utah requires pharmacists to: (1) offer counseling, (2) document counseling has been offered, (3) offer a counseling process for patients not present, and (4) discuss generic substitution.The duration of SMC in the current study is a single 5-10 minute session delivered by a University of Utah pharmacist other than the study pharmacist that possesses a similar level of education and professional licensing. Receives: Other: Standard Medication Counseling (SMC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in opioid medication misuse.
This outcome will be assessed using the Prescription Opioid Misuse Index (POMI).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start8 Nov 2021
- Primary completion19 Jun 2026
- Study completion1 Jul 2027 (estimated)
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 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jerry Cochran
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Jerry Cochran, University of Utah
- Investigators
- Gerald Cochran, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05141266
- Sponsor's protocol ID
- 141016
- Acronym
- HOPE
- Status last verified
- Jul 2026
- First submitted
- 8 Nov 2021
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cochran G, Shen J, Cox N, Field C, Carlston K, Sengpraseut B, White A, Okifuji A, Jackman C, Haaland B, Ragsdale R, Gordon AJ, Tarter R. Addressing opioid medication misuse at point of service in community pharmacy: A study protocol for an interdisciplinary behavioral health trial. Contemp Clin Trials. 2022 May;116:106759. doi: 10.1016/j.cct.2022.106759. Epub 2022 Apr 11.
PubMed 35417771
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Opioid Prescription Engagement 2.0
- ClinicalTrials.gov ID
- NCT05141266
- Acronym / sponsor ID
- HOPE / 141016
- Keywords
- Community Pharmacies, Patient Navigation, Opioid intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Jerry CochranUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 19 Jun 2026 (actual)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 2 Dec 2021 (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.
This study is a randomized controlled trial across 14 community pharmacies to test the efficacy of the Brief Intervention-Medication Therapy Management intervention (BI-MTM). The establishment of the BI-MTM model will result in a major impact for addressing the opioid epidemic, preventing opioid use disorder and overdose, and safeguarding patient health in a novel community-based service setting.
Detailed description
This study examines a community pharmacy-based intervention to reduce opioid medication misuse. Despite a recent national decline in opioid prescribing, 10.3 million Americans in 2018 reported misusing a prescribed opioid, and within this population, >36% of those who misused obtained the opioid medication by filling a prescription. The point of medication dispensing, namely, the community pharmacy, is an untapped resource to address prescription opioid misuse-especially when considering the >60,000 pharmacies employing >170,000 pharmacists in the US. This study aims to conduct a fully-powered RCT of the BI-MTM intervention in community pharmacy settings that will accomplish 3 Specific Aims. The first Aim will demonstrate the pharmacist-led BI-MTM intervention is superior to standard medication counseling (SMC) for mitigating opioid medication misuse. This will be accomplished by conducting a powered single-blinded randomized trial to test the efficacy of BI-MTM (n=175) vs. SMC (n=175). Participants will be screened/recruited for eligibility at point of dispensing in 14 community pharmacies in Utah, a high opioid prescribing and opioid-adverse event state. Participants will be assessed at baseline, 2, and 6 months for opioid medication misuse. Participant-level state prescription drug monitoring data will also be linked with patient outcomes to assess objective changes in medication misuse behaviors (e.g., early refills and doctor/pharmacy shopping). The second Aim will identify the pathway by which BI-MTM results in improvements for depression, pain, and subsequently opioid misuse. To accomplish this, a path analysis will assess relationships of BI-MTM: (1) on depression, pain, and misuse, (2) depression on misuse, and (3) pain on misuse. The final Aim will explore latent transitions of baseline to post-intervention misuse classes by intervention group. This will be accomplished by using mixture modeling, specifically multi-group latent transition analysis. The observed misuse indicators will be used to estimate latent class transitions across time, grouping by treatment condition and adjusting for baseline covariates. Completing SA1- 3 advance the understanding of BI-MTM efficacy and set the stage for a national multisite trial.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Intervention Medication Therapy Management (BI-MTM) | Experimental | Behavioral: Patient NavigationBrief Intervention Medication Therapy Management (BI-MTM) is the overarching model made up of 4 evidence-based components: Medication Therapy Management (MTM); Screening, Brief Intervention, and Referral to Treatment (SBIRT); naloxone dispensing, and Patient Navigation (PN). Each component is sequentially delivered within the model and addresses a critical aspect of opioid medication misuse and risk. The pharmacy-based portion of BI-MTM (MTM+SBIRT+naloxone) will be delivered by a PharmD level pharmacist, and PN will be delivered by a bachelor's level interventionist. |
| Standard of Care | Other | Other: Standard Medication Counseling (SMC)Standard of Care is the treatment as usual condition, which follows federal and Utah state pharmacy requirements for pharmacists where in patients filling prescriptions receive information and opt-in counseling. Specifically, SMC in Utah requires pharmacists to: (1) offer counseling, (2) document counseling has been offered, (3) offer a counseling process for patients not present, and (4) discuss generic substitution.The duration of SMC in the current study is a single 5-10 minute session delivered by a University of Utah pharmacist other than the study pharmacist that possesses a similar level of education and professional licensing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult (≥18 years)
- English speaking
- Not receiving cancer treatment
- Who have a positive opioid misuse screen on the POMI will be eligible to learn about this study
Key exclusion criteria (7 listed)
- Are pregnant (given potential pre/post-natal opioid use complications among pregnant women/offspring
- Can-not provide collateral contact information for ≥2 contact persons (to ensure consistent contact/follow up)
- Do not have a reliable land line or mobile phone to be contacted by study staff
- Are filling only buprenorphine (given some formulations are not indicated for pain)
- Plan to leave the area for an extended period of time in the next 6 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 |
|---|---|---|
| Patient NavigationPN involves 8 weekly telephonic sessions lasting 30-45 minutes (telephonic to support lower-costs/sustainability). In session 1, the navigator reviews with the participant a report of scores from the baseline assessment to understand the participant's current health needs/challenges; session 1 also involves development of therapeutic alliance/rapport and goal setting. Sessions 2-4 focus on goal setting and identifying barriers and problem resolutions. The navigator elicits motivation and discusses this in context of readiness to change heath behavior and self-management skills. Sessions 2-4 also involve navigators supporting/assisting patients to fill out paperwork and enroll in needed social services and/or mental/behavioral/physical healthcare, including but not limited to primary care. Sessions 5-7 focus on encouraging and reinforcing treatment adherence, review-ing and identifying other care needs, and offering linkages to service providers as applicable | Behavioural | Brief Intervention Medication Therapy Management (BI-MTM) |
| Standard Medication Counseling (SMC)SMC participants receive a single medication information/counseling session delivered by a University of Utah pharmacist to: (1) offer counseling, (2) document counseling was offered, (3) offer a counseling process for patients not present (not applicable to this study given all patients must screen in person), and (4) discuss generic substitution. | Other | Standard of Care |
Primary outcome
Change in opioid medication misuse.
Time frame: 6 months
This outcome will be assessed using the Prescription Opioid Misuse Index (POMI).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Derived from this study: PubMed 35417771Cochran G, Shen J, Cox N, Field C, Carlston K, Sengpraseut B, White A, Okifuji A, Jackman C, Haaland B, Ragsdale R, Gordon AJ, Tarter R. Addressing opioid medication misuse at point of service in community pharmacy: A study protocol for an interdisciplinary behavioral health trial. Contemp Clin Trials. 2022 May;116:106759. doi: 10.1016/j.cct.2022.106759. Epub 2022 Apr 11.
- 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.
Gerald Cochran, PhD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Navigation and Standard Medication Counseling (SMC) in people with Opioid Misuse and Opioid-Related Disorders, run by Jerry Cochran 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 7 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: under way, not looking for participants, as of the sponsor's last update on 17 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in opioid medication misuse. (time frame: 6 months). 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 NCT05141266, 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 17 Jul 2026.