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Buprenorphine Physician-Pharmacist Collaboration in the Management of Patients With Opioid Use Disorder: CTN 0075 (Pharm-OUD-Care)

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ClinicalTrials.gov Identifier: NCT03248947
Recruitment Status : Completed
First Posted : August 15, 2017
Results First Posted : August 10, 2020
Last Update Posted : July 28, 2021
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
The Emmes Company, LLC
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Opioid Use Disorder
Interventions Drug: buprenorphine/naloxone
Other: Pharmacist-administered buprenorphine/naloxone maintenance care
Enrollment 71
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pharmacist-administered Buprenorphine Maintenance Care
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 71
Completed 63
Not Completed 8
Arm/Group Title Pharmacist-administered Buprenorphine Maintenance Care
Hide Arm/Group Description 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 Number of Baseline Participants 71
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants
<=18 years
0
   0.0%
Between 18 and 65 years
70
  98.6%
>=65 years
1
   1.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants
Female
28
  39.4%
Male
43
  60.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants
Hispanic or Latino
1
   1.4%
Not Hispanic or Latino
70
  98.6%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
9
  12.7%
White
61
  85.9%
More than one race
0
   0.0%
Unknown or Not Reported
1
   1.4%
Opioid positive UDS at screening   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants
6
   8.5%
[1]
Measure Description: UDS = urine drug screening
1.Primary Outcome
Title Recruitment Rate
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-screened Participants Consented Participants
Hide Arm/Group Description:
Potential study participants who were approached by research staff to assess basic study eligibility and interest in study participation.
Participants who signed the study informed consent form and then underwent screening to determine study eligibility.
Overall Number of Participants Analyzed 92 76
Measure Type: Count of Participants
Unit of Measure: Participants
Pre-screened participants consented
76
  82.6%
NA [1] 
Consented participants enrolled into study NA [2] 
71
  93.4%
[1]
Row data only applies to pre-screened participants.
[2]
Row data only applies to consented participants.
2.Primary Outcome
Title Treatment Retention
Hide Description Number of scheduled visits completed.
Time Frame Up to six months
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Pharmacist-administered Buprenorphine Maintenance Care
Hide Arm/Group Description:
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 Number of Participants Analyzed 71
Overall Number of Units Analyzed
Type of Units Analyzed: Visits
426
Count of Units
Unit of Measure: Visits
406
  95.3%
3.Primary Outcome
Title Number of Participants With Opioid and Other Substance Use
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Missing UDS imputed as positive
Arm/Group Title Pharmacist-administered Buprenorphine Maintenance Care
Hide Arm/Group Description:
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 Number of Participants Analyzed 71
Measure Type: Count of Participants
Unit of Measure: Participants
Positive opioid UDS at month 6
10
  14.1%
Positive other substance UDS at month 6
38
  53.5%
Self-reported opioid use at month 6
10
  14.1%
4.Primary Outcome
Title Number of Medication-Compliant Months Across All Participants
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pharmacist-administered Buprenorphine Maintenance Care
Hide Arm/Group Description:
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 Number of Participants Analyzed 71
Overall Number of Units Analyzed
Type of Units Analyzed: Months
426
Count of Units
Unit of Measure: Months
406
  95.3%
5.Secondary Outcome
Title Treatment Fidelity
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Pharmacist-administered Buprenorphine Maintenance Care
Hide Arm/Group Description:
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 Number of Participants Analyzed 71
Overall Number of Units Analyzed
Type of Units Analyzed: Monitored study visits
142
Count of Units
Unit of Measure: Monitored study visits
142
 100.0%
6.Secondary Outcome
Title Treatment Satisfaction
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the study.
Arm/Group Title Pharmacist-administered Buprenorphine Maintenance Care Study Physicians and Pharmacists
Hide Arm/Group Description:
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.
Comprised of the physicians (n=6) and pharmacists (n=6) who participated in the study.
Overall Number of Participants Analyzed 63 12
Measure Type: Count of Participants
Unit of Measure: Participants
Overall satisfaction with experience in study Very Satisfied
59
  93.7%
12
 100.0%
Satisfied
3
   4.8%
0
   0.0%
Neither Satisfied or Dissatisfied
0
   0.0%
0
   0.0%
Dissatisfied
1
   1.6%
0
   0.0%
Very Dissatisfied
0
   0.0%
0
   0.0%
Overall satisfaction with quality of study treatmt Very Satisfied
57
  90.5%
11
  91.7%
Satisfied
5
   7.9%
1
   8.3%
Neither Satisfied or Dissatisfied
0
   0.0%
0
   0.0%
Dissatisfied
1
   1.6%
0
   0.0%
Very Dissatisfied
0
   0.0%
0
   0.0%
7.Secondary Outcome
Title Participant Safety
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pharmacist-administered Buprenorphine Maintenance Care
Hide Arm/Group Description:
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 Number of Participants Analyzed 71
Measure Type: Count of Participants
Unit of Measure: Participants
Overdoses
0
   0.0%
Substance-related ED visits
1
   1.4%
Substance-related hospitalizations
1
   1.4%
8.Secondary Outcome
Title Pharmacists' Use of the Prescription Drug Monitoring Program (PDMP)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Pharmacist-administered Buprenorphine Maintenance Care
Hide Arm/Group Description:
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 from the physician.
Overall Number of Participants Analyzed 71
Overall Number of Units Analyzed
Type of Units Analyzed: Visits
409
Count of Units
Unit of Measure: Visits
396
  96.8%
Time Frame 6 months
Adverse Event Reporting Description 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.
 
Arm/Group Title Pharmacist-administered Buprenorphine Maintenance Care
Hide Arm/Group Description 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.
All-Cause Mortality
Pharmacist-administered Buprenorphine Maintenance Care
Affected / at Risk (%)
Total   0/71 (0.00%)    
Hide Serious Adverse Events
Pharmacist-administered Buprenorphine Maintenance Care
Affected / at Risk (%) # Events
Total   2/71 (2.82%)    
Injury, poisoning and procedural complications   
Thermal burn  1 [1]  1/71 (1.41%)  1
Musculoskeletal and connective tissue disorders   
Muscle spasm  1 [2]  1/71 (1.41%)  1
1
Term from vocabulary, MedDRA (Unspecified)
Indicates events were collected by systematic assessment
[1]
1st, 2nd and 3rd degree burn; resulted in hospitalization.
[2]
Muscle cramping from i.v. cocaine use.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pharmacist-administered Buprenorphine Maintenance Care
Affected / at Risk (%) # Events
Total   0/71 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Li-Tzy Wu
Organization: Duke University
Phone: 919-889-9369
EMail: litzy.wu@duke.edu
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03248947    
Other Study ID Numbers: Pro00083544
UG1DA040317 ( U.S. NIH Grant/Contract )
First Submitted: August 10, 2017
First Posted: August 15, 2017
Results First Submitted: June 18, 2020
Results First Posted: August 10, 2020
Last Update Posted: July 28, 2021