Opioid Use Disorder
Conditions
Keywords
opioid use disorder, Medication-assisted treatment, Buprenorphine treatment, Collaborative care model
Brief summary
This pilot study examines the feasibility and acceptability of transitioning office-based buprenorphine treatment of opioid use disorder from physicians to pharmacists. Results from this study will inform the development of a future multi-site randomized clinical trial.
Detailed description
The overall objective of this study is to explore the feasibility of transitioning the care of adult patients with opioid use disorder (OUD) who receive office-based buprenorphine treatment (OBBT) from physicians to pharmacists. Physicians will induce buprenorphine treatment and complete the stabilization phase before referring patients to pharmacists for the management of monthly maintenance visits. This study will assess the feasibility and acceptability of a collaborative care model between physician and pharmacist by measuring recruitment rate, treatment retention rate, treatment compliance rate, and participants' substance use. Other assessments measured will include treatment fidelity, participant, physician, and pharmacist satisfaction with OUD care, participant safety, and the pharmacists' use of electronic health records and the Prescription Drug Monitoring Program.
Interventions
DRUGbuprenorphine/naloxone
To relieve opioid withdrawal symptoms and craving, buprenorphine/naloxone will be prescribed by the study-physician and dispensed by the study-pharmacist on a monthly basis. The median expected dose is 16 mg daily, though adjustment by the study physician may be needed due to increased withdrawal and craving from previous study visits. Medication will be provided in the form of a sublingual film.
OTHERPharmacist-administered buprenorphine/naloxone maintenance care
Following buprenorphine/naloxone induction/stabilization with the physician, participants with opioid use disorder will be transferred to the care of pharmacists for the maintenance phase of treatment. Maintenance visits will occur monthly with the pharmacist at the pharmacy location for six months. Buprenorphine/naloxone will be dispensed by the pharmacist at the monthly study visits following participant assessment, communication with the physician, and prescription form the physician.
Sponsors
National Institute on Drug Abuse (NIDA)
The Emmes Company, LLC
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Be adults aged 18 years or older. * If female, use adequate birth control methods. * Meet DSM-5 criteria for past-year OUD and have completed buprenorphine induction for OUD. * Have expressed the intention to receive maintenance (≥6 months) buprenorphine treatment. * Be willing to receive pharmacist administered buprenorphine maintenance treatment * Be willing and able to provide written informed consent and HIPAA authorization. * Be able to read and communicate in English. * Be able to comply with buprenorphine treatment policies.
Exclusion criteria
* Have a serious medical, psychiatric or substance use disorder that, in the opinion of the study physician, would make study participation hazardous to the participant, compromise study findings, or prevent the participant from completing the study. * Have known allergy or hypersensitivity to buprenorphine, naloxone, or other components of the buprenorphine/naloxone formulation. * Have aspartate aminotransferase (AST) or alanine aminotransferase (ALT) liver enzymes greater than 5 times the upper limit of normal on screening phlebotomy performed within 60 days prior to the date of the last stabilization visit. * Have chronic pain requiring ongoing pain management with opioid analgesics. * Pending legal action or other reasons that might prevent an individual from completing the study (i.e., unable to complete 6 months of pharmacy-based OUD management). * Pregnant or breastfeeding at the time of screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Medication-Compliant Months Across All Participants | Up to six months | Medication compliance is defined as taking any of the dispensed medication during the past month as measured by pill count/dose reconciliation at each study visit. Medication compliance is calculated as the percentage of compliant months out of the overall number of expected study months. |
| Recruitment Rate | Up to six months | Measured by a composite of the number of participants with opioid use disorder recruited (i.e., signed the informed consent form) per month, and by site and the average monthly rate of participants enrolled among potential participants who were screened. |
| Treatment Retention | Up to six months | Number of scheduled visits completed. |
| Number of Participants With Opioid and Other Substance Use | Up to six months | Measured via a composite of urine drug screen (UDS) and self-report via Timeline Follow-Back over 30 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Fidelity | Up to six months | Number of monitored study visits with physicians and pharmacists showing 80% adherence or higher to study specific tasks and responsibilities. Adherence will be calculated as the number of items completed on the Buprenorphine Visit Checklist divided by the sum of the number of complete and incomplete items. |
| Treatment Satisfaction | Up to six months | Indicators of satisfaction with treatment delivery measured by participants, pharmacists, and physicians using the Treatment Satisfaction Scale after each study visit. A score of 5=very satisfied, 4=satisfied, 3=neither satisfied or dissatisfied, 2=dissatisfied, and 1=very dissatisfied. |
| Participant Safety | Up to six months | A composite of self-report and medical record abstraction to measure any fatal or non-fatal opioid overdose and any opioid or other substance-related emergency department visit or hospitalization. |
| Pharmacists' Use of the Prescription Drug Monitoring Program (PDMP) | Up to six months | Measured at each study visit via an action item checklist to confirm whether the PDMP was inquired to identify the following for each participant: measures of multiple buprenorphine prescriptions, any prescriptions for class II and III medications, and any other information that may be useful for the participant's treatment such as documented drug-related medical interventions or disciplinary charges. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pharmacist-administered Buprenorphine Maintenance Care Following buprenorphine/naloxone induction/stabilization with the physician, participants with opioid use disorder will be transferred to the care of pharmacists for the maintenance phase of treatment. Maintenance visits will occur monthly with the pharmacist at the pharmacy location for six months. Buprenorphine/naloxone will be dispensed by the pharmacist at the monthly study visits following participant assessment, communication with the physician, and prescription form the physician. | 71 |
| Total | 71 |
Baseline characteristics
| Characteristic | Pharmacist-administered Buprenorphine Maintenance Care |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 70 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 70 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Opioid positive UDS at screening | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 61 Participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 71 |
| other Total, other adverse events | 0 / 71 |
| serious Total, serious adverse events | 2 / 71 |
Outcome results
Primary
Number of Medication-Compliant Months Across All Participants
Medication compliance is defined as taking any of the dispensed medication during the past month as measured by pill count/dose reconciliation at each study visit. Medication compliance is calculated as the percentage of compliant months out of the overall number of expected study months.
Time frame: Up to six months
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Pre-screened Participants | Number of Medication-Compliant Months Across All Participants | 406 Months |
Primary
Number of Participants With Opioid and Other Substance Use
Measured via a composite of urine drug screen (UDS) and self-report via Timeline Follow-Back over 30 days.
Time frame: Up to six months
Population: Missing UDS imputed as positive
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pre-screened Participants | Number of Participants With Opioid and Other Substance Use | Positive opioid UDS at month 6 | 10 Participants |
| Pre-screened Participants | Number of Participants With Opioid and Other Substance Use | Positive other substance UDS at month 6 | 38 Participants |
| Pre-screened Participants | Number of Participants With Opioid and Other Substance Use | Self-reported opioid use at month 6 | 10 Participants |
Primary
Recruitment Rate
Measured by a composite of the number of participants with opioid use disorder recruited (i.e., signed the informed consent form) per month, and by site and the average monthly rate of participants enrolled among potential participants who were screened.
Time frame: Up to six months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pre-screened Participants | Recruitment Rate | Pre-screened participants consented | 76 Participants |
| Pre-screened Participants | Recruitment Rate | Consented participants enrolled into study | NA Participants |
| Consented Participants | Recruitment Rate | Pre-screened participants consented | NA Participants |
| Consented Participants | Recruitment Rate | Consented participants enrolled into study | 71 Participants |
Primary
Treatment Retention
Number of scheduled visits completed.
Time frame: Up to six months
Population: The number of expected study visits for each participant is 6, based on 1 visit per month for the 6 months of the study arm. The overall number of expected study visits for all participants is 426, based on 6 visits per participant multiplied by 71 participants in the study arm.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Pre-screened Participants | Treatment Retention | 406 Visits |
Secondary
Participant Safety
A composite of self-report and medical record abstraction to measure any fatal or non-fatal opioid overdose and any opioid or other substance-related emergency department visit or hospitalization.
Time frame: Up to six months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pre-screened Participants | Participant Safety | Overdoses | 0 Participants |
| Pre-screened Participants | Participant Safety | Substance-related ED visits | 1 Participants |
| Pre-screened Participants | Participant Safety | Substance-related hospitalizations | 1 Participants |
Secondary
Pharmacists' Use of the Prescription Drug Monitoring Program (PDMP)
Measured at each study visit via an action item checklist to confirm whether the PDMP was inquired to identify the following for each participant: measures of multiple buprenorphine prescriptions, any prescriptions for class II and III medications, and any other information that may be useful for the participant's treatment such as documented drug-related medical interventions or disciplinary charges.
Time frame: Up to six months
Population: The total number of visits (409) represent the total number of study visits attended in the maintenance phase (n=406) plus early-termination visits (n=3) that are counted separately.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Pre-screened Participants | Pharmacists' Use of the Prescription Drug Monitoring Program (PDMP) | 396 Visits |
Secondary
Treatment Fidelity
Number of monitored study visits with physicians and pharmacists showing 80% adherence or higher to study specific tasks and responsibilities. Adherence will be calculated as the number of items completed on the Buprenorphine Visit Checklist divided by the sum of the number of complete and incomplete items.
Time frame: Up to six months
Population: A total of 142 study visits were monitored for adherence to study tasks and responsibilities via completion of the Buprenorphine Visit Checklist. The percentage of monitored study visits with 80% adherence out of the total number of monitored study visits was calculated.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Pre-screened Participants | Treatment Fidelity | 142 Monitored study visits |
Secondary
Treatment Satisfaction
Indicators of satisfaction with treatment delivery measured by participants, pharmacists, and physicians using the Treatment Satisfaction Scale after each study visit. A score of 5=very satisfied, 4=satisfied, 3=neither satisfied or dissatisfied, 2=dissatisfied, and 1=very dissatisfied.
Time frame: Up to six months
Population: Participants who completed the study.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Pre-screened Participants | Treatment Satisfaction | Overall satisfaction with experience in study | Very Satisfied | 59 Participants |
| Pre-screened Participants | Treatment Satisfaction | Overall satisfaction with experience in study | Satisfied | 3 Participants |
| Pre-screened Participants | Treatment Satisfaction | Overall satisfaction with experience in study | Neither Satisfied or Dissatisfied | 0 Participants |
| Pre-screened Participants | Treatment Satisfaction | Overall satisfaction with experience in study | Dissatisfied | 1 Participants |
| Pre-screened Participants | Treatment Satisfaction | Overall satisfaction with experience in study | Very Dissatisfied | 0 Participants |
| Pre-screened Participants | Treatment Satisfaction | Overall satisfaction with quality of study treatmt | Very Satisfied | 57 Participants |
| Pre-screened Participants | Treatment Satisfaction | Overall satisfaction with quality of study treatmt | Satisfied | 5 Participants |
| Pre-screened Participants | Treatment Satisfaction | Overall satisfaction with quality of study treatmt | Neither Satisfied or Dissatisfied | 0 Participants |
| Pre-screened Participants | Treatment Satisfaction | Overall satisfaction with quality of study treatmt | Dissatisfied | 1 Participants |
| Pre-screened Participants | Treatment Satisfaction | Overall satisfaction with quality of study treatmt | Very Dissatisfied | 0 Participants |
| Consented Participants | Treatment Satisfaction | Overall satisfaction with quality of study treatmt | Neither Satisfied or Dissatisfied | 0 Participants |
| Consented Participants | Treatment Satisfaction | Overall satisfaction with experience in study | Very Satisfied | 12 Participants |
| Consented Participants | Treatment Satisfaction | Overall satisfaction with quality of study treatmt | Very Satisfied | 11 Participants |
| Consented Participants | Treatment Satisfaction | Overall satisfaction with experience in study | Satisfied | 0 Participants |
| Consented Participants | Treatment Satisfaction | Overall satisfaction with quality of study treatmt | Very Dissatisfied | 0 Participants |
| Consented Participants | Treatment Satisfaction | Overall satisfaction with experience in study | Neither Satisfied or Dissatisfied | 0 Participants |
| Consented Participants | Treatment Satisfaction | Overall satisfaction with quality of study treatmt | Satisfied | 1 Participants |
| Consented Participants | Treatment Satisfaction | Overall satisfaction with experience in study | Dissatisfied | 0 Participants |
| Consented Participants | Treatment Satisfaction | Overall satisfaction with quality of study treatmt | Dissatisfied | 0 Participants |
| Consented Participants | Treatment Satisfaction | Overall satisfaction with experience in study | Very Dissatisfied | 0 Participants |