Trial Outcomes & Findings for Buprenorphine Physician-Pharmacist Collaboration in the Management of Patients With Opioid Use Disorder: CTN 0075 (NCT NCT03248947)

Last Updated: 2021-07-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

71 participants

Primary outcome timeframe

Up to six months

Results posted on

2021-07-28

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	71
Overall Study COMPLETED	63
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Buprenorphine Physician-Pharmacist Collaboration in the Management of Patients With Opioid Use Disorder: CTN 0075

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pharmacist-administered Buprenorphine Maintenance Care n=71 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	70 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	70 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants
Race (NIH/OMB) White	61 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Opioid positive UDS at screening	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to six months

Outcome measures

Outcome measures
Measure	Pre-screened Participants n=92 Participants Potential study participants who were approached by research staff to assess basic study eligibility and interest in study participation.	Consented Participants n=76 Participants Participants who signed the study informed consent form and then underwent screening to determine study eligibility.
Recruitment Rate Pre-screened participants consented	76 Participants	NA Participants Row data only applies to pre-screened participants.
Recruitment Rate Consented participants enrolled into study	NA Participants Row data only applies to consented participants.	71 Participants

PRIMARY outcome

Timeframe: 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.

Number of scheduled visits completed.

Outcome measures

Outcome measures
Measure	Pre-screened Participants n=426 Visits Potential study participants who were approached by research staff to assess basic study eligibility and interest in study participation.	Consented Participants Participants who signed the study informed consent form and then underwent screening to determine study eligibility.
Treatment Retention	406 Visits	—

PRIMARY outcome

Timeframe: Up to six months

Population: Missing UDS imputed as positive

Measured via a composite of urine drug screen (UDS) and self-report via Timeline Follow-Back over 30 days.

Outcome measures

Outcome measures
Measure	Pre-screened Participants n=71 Participants Potential study participants who were approached by research staff to assess basic study eligibility and interest in study participation.	Consented Participants Participants who signed the study informed consent form and then underwent screening to determine study eligibility.
Number of Participants With Opioid and Other Substance Use Positive opioid UDS at month 6	10 Participants	—
Number of Participants With Opioid and Other Substance Use Positive other substance UDS at month 6	38 Participants	—
Number of Participants With Opioid and Other Substance Use Self-reported opioid use at month 6	10 Participants	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Pre-screened Participants n=426 Months Potential study participants who were approached by research staff to assess basic study eligibility and interest in study participation.	Consented Participants Participants who signed the study informed consent form and then underwent screening to determine study eligibility.
Number of Medication-Compliant Months Across All Participants	406 Months	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Pre-screened Participants n=142 Monitored study visits Potential study participants who were approached by research staff to assess basic study eligibility and interest in study participation.	Consented Participants Participants who signed the study informed consent form and then underwent screening to determine study eligibility.
Treatment Fidelity	142 Monitored study visits	—

SECONDARY outcome

Timeframe: Up to six months

Population: Participants who completed the study.

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.

Outcome measures

Outcome measures
Measure	Pre-screened Participants n=63 Participants Potential study participants who were approached by research staff to assess basic study eligibility and interest in study participation.	Consented Participants n=12 Participants Participants who signed the study informed consent form and then underwent screening to determine study eligibility.
Treatment Satisfaction Overall satisfaction with experience in study · Very Satisfied	59 Participants	12 Participants
Treatment Satisfaction Overall satisfaction with experience in study · Satisfied	3 Participants	0 Participants
Treatment Satisfaction Overall satisfaction with experience in study · Neither Satisfied or Dissatisfied	0 Participants	0 Participants
Treatment Satisfaction Overall satisfaction with experience in study · Dissatisfied	1 Participants	0 Participants
Treatment Satisfaction Overall satisfaction with experience in study · Very Dissatisfied	0 Participants	0 Participants
Treatment Satisfaction Overall satisfaction with quality of study treatmt · Very Satisfied	57 Participants	11 Participants
Treatment Satisfaction Overall satisfaction with quality of study treatmt · Satisfied	5 Participants	1 Participants
Treatment Satisfaction Overall satisfaction with quality of study treatmt · Neither Satisfied or Dissatisfied	0 Participants	0 Participants
Treatment Satisfaction Overall satisfaction with quality of study treatmt · Dissatisfied	1 Participants	0 Participants
Treatment Satisfaction Overall satisfaction with quality of study treatmt · Very Dissatisfied	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Pre-screened Participants n=71 Participants Potential study participants who were approached by research staff to assess basic study eligibility and interest in study participation.	Consented Participants Participants who signed the study informed consent form and then underwent screening to determine study eligibility.
Participant Safety Overdoses	0 Participants	—
Participant Safety Substance-related ED visits	1 Participants	—
Participant Safety Substance-related hospitalizations	1 Participants	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Pre-screened Participants n=409 Visits Potential study participants who were approached by research staff to assess basic study eligibility and interest in study participation.	Consented Participants Participants who signed the study informed consent form and then underwent screening to determine study eligibility.
Pharmacists' Use of the Prescription Drug Monitoring Program (PDMP)	396 Visits	—

Adverse Events

Pharmacist-administered Buprenorphine Maintenance Care

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pharmacist-administered Buprenorphine Maintenance Care n=71 participants at risk 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.
Musculoskeletal and connective tissue disorders Muscle spasm	1.4% 1/71 • Number of events 1 • 6 months Collection of safety events was limited to those collected on the Safety Event Response Checklist (SERC-75), which was completed at each visit. There are fifteen types of safety events reported on the SERC-75, including overdoses (ODs), emergency department (ED) visits, hospitalizations, and deaths.
Injury, poisoning and procedural complications Thermal burn	1.4% 1/71 • Number of events 1 • 6 months Collection of safety events was limited to those collected on the Safety Event Response Checklist (SERC-75), which was completed at each visit. There are fifteen types of safety events reported on the SERC-75, including overdoses (ODs), emergency department (ED) visits, hospitalizations, and deaths.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Li-Tzy Wu

Duke University

Phone: 919-889-9369

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place