Trial · NCT03248947

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

NCT03248947, Early phase 1, Completed, Duke University; results first posted 2020-08-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Buprenorphine Physician-Pharmacist Collaboration in the Management of Patients With Opioid Use Disorder: CTN 0075. Trials, record NCT03248947. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03248947

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Buprenorphine Physician-Pharmacist Collaboration in the Management of Patients With Opioid Use Disorder: CTN 0075
NCT number: NCT03248947
Status: Completed
Phases: Early phase 1
Enrollment: 71 participants, actual
Lead sponsor: Duke University
Conditions: Opioid Use Disorder
Interventions: buprenorphine/naloxone, Pharmacist-administered buprenorphine/naloxone maintenance care
First posted: 2017-08-15
Last updated: 2021-07-28
Results first posted: 2020-08-10

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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.
Primary	Treatment Retention	Up to six months	Number of scheduled visits completed.
Primary	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.
Primary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Recruitment Rate	Up to six months		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Treatment Retention	Up to six months	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.	Visits	COUNT_OF_UNITS
PRIMARY	Number of Participants With Opioid and Other Substance Use	Up to six months	Missing UDS imputed as positive	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Medication-Compliant Months Across All Participants	Up to six months		Months	COUNT_OF_UNITS
SECONDARY	Treatment Fidelity	Up to six months	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.	Monitored study visits	COUNT_OF_UNITS
SECONDARY	Treatment Satisfaction	Up to six months	Participants who completed the study.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Participant Safety	Up to six months		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Pharmacists' Use of the Prescription Drug Monitoring Program (PDMP)	Up to six months	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.	Visits	COUNT_OF_UNITS

Source ClinicalTrials.gov

Results by group34

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Recruitment Rate	Pre-screened Participants	Pre-screened participants consented	76	Participants
Recruitment Rate	Consented Participants	Pre-screened participants consented	NA	Participants
Recruitment Rate	Pre-screened Participants	Consented participants enrolled into study	NA	Participants
Recruitment Rate	Consented Participants	Consented participants enrolled into study	71	Participants
Treatment Retention	Pharmacist-administered Buprenorphine Maintenance Care		406	Visits
Number of Participants With Opioid and Other Substance Use	Pharmacist-administered Buprenorphine Maintenance Care	Positive opioid UDS at month 6	10	Participants
Number of Participants With Opioid and Other Substance Use	Pharmacist-administered Buprenorphine Maintenance Care	Positive other substance UDS at month 6	38	Participants
Number of Participants With Opioid and Other Substance Use	Pharmacist-administered Buprenorphine Maintenance Care	Self-reported opioid use at month 6	10	Participants
Number of Medication-Compliant Months Across All Participants	Pharmacist-administered Buprenorphine Maintenance Care		406	Months
Treatment Fidelity	Pharmacist-administered Buprenorphine Maintenance Care		142	Monitored study visits

1 to 10 of 34Source ClinicalTrials.gov

See all 34 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Pharmacist-administered Buprenorphine Maintenance Care	71
Overall Study	COMPLETED	Pharmacist-administered Buprenorphine Maintenance Care	63
Overall Study	NOT COMPLETED	Pharmacist-administered Buprenorphine Maintenance Care	8

Source ClinicalTrials.gov

Adverse events2

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
serious	Muscle spasm	Musculoskeletal and connective tissue disorders	Pharmacist-administered Buprenorphine Maintenance Care	1	71	1
serious	Thermal burn	Injury, poisoning and procedural complications	Pharmacist-administered Buprenorphine Maintenance Care	1	71	1

Source ClinicalTrials.gov

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pharmacist-administered Buprenorphine Maintenance Care	0	71
Total, other adverse events	Pharmacist-administered Buprenorphine Maintenance Care	0	71
Total, serious adverse events	Pharmacist-administered Buprenorphine Maintenance Care	2	71

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33428284	RESULT

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
UG1DA040317	Mid Southern Primary Care Networks Node	WU, LI-TZY	DUKE UNIVERSITY	NATIONAL INSTITUTE ON DRUG ABUSE	2015 to 2019

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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