Trial Outcomes & Findings for Opioid Treatment Program (OTP)-Pharmacy Collaboration for Methadone Maintenance Treatment (NCT NCT04308694)
NCT ID: NCT04308694
Last Updated: 2022-04-01
Results Overview
The recruitment rate will be assessed on a monthly basis (e.g, Month 1, 2 and 3) until the enrollment target is reached. The recruitment rate is operationalized as the total number of participants consented in one month.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
20 participants
Primary outcome timeframe
3 months
Results posted on
2022-04-01
Participant Flow
Participant milestones
| Measure |
Pharmacy-based Methadone Treatment
Participants will have their usual methadone dose administered and dispensed at a participating pharmacy. All other methadone services including counseling, drug testing, and medical services will be delivered as usual at the Methadone Program.
Pharmacy-based methadone administration and dispensing: Eligible participants receiving between 6- and 13-days of methadone take-home doses will have methadone administration and dispensing transferred from the opioid treatment program to the partnered community pharmacy. Each participant will be assessed monthly for 3 months (at 1, 2, and 3 months following intake/baseline) to explore the feasibility of transferring their methadone administration and dispensing to the select community pharmacy.
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|---|---|
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Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
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16
|
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Overall Study
NOT COMPLETED
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4
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Opioid Treatment Program (OTP)-Pharmacy Collaboration for Methadone Maintenance Treatment
Baseline characteristics by cohort
| Measure |
Pharmacy-based Methadone Treatment
n=20 Participants
Participants will have their usual methadone dose administered and dispensed at a participating pharmacy. All other methadone services including counseling, drug testing, and medical services will be delivered as usual at the Methadone Program.
Pharmacy-based methadone administration and dispensing: Eligible participants receiving between 6- and 13-days of methadone take-home doses will have methadone administration and dispensing transferred from the opioid treatment program to the partnered community pharmacy. Each participant will be assessed monthly for 3 months (at 1, 2, and 3 months following intake/baseline) to explore the feasibility of transferring their methadone administration and dispensing to the select community pharmacy.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
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20 Participants
n=5 Participants
|
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
|
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Sex: Female, Male
Female
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14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
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6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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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
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1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
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Region of Enrollment
United States
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20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsThe recruitment rate will be assessed on a monthly basis (e.g, Month 1, 2 and 3) until the enrollment target is reached. The recruitment rate is operationalized as the total number of participants consented in one month.
Outcome measures
| Measure |
Pharmacy-based Methadone Treatment
n=20 Participants
Participants will have their usual methadone dose administered and dispensed at a participating pharmacy. All other methadone services including counseling, drug testing, and medical services will be delivered as usual at the Methadone Program.
Pharmacy-based methadone administration and dispensing: Eligible participants receiving between 6- and 13-days of methadone take-home doses will have methadone administration and dispensing transferred from the opioid treatment program to the partnered community pharmacy. Each participant will be assessed monthly for 3 months (at 1, 2, and 3 months following intake/baseline) to explore the feasibility of transferring their methadone administration and dispensing to the select community pharmacy.
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|---|---|
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Recruitment Rate
Month 1
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3 Participants
|
|
Recruitment Rate
Month 2
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12 Participants
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|
Recruitment Rate
Month 3
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5 Participants
|
PRIMARY outcome
Timeframe: Up to 3 months per participantPopulation: All participants who began pharmacy-based methadone treatment.
Adherence to pharmacy-based methadone treatment will be defined as the percentage of methadone take-home doses dispensed at the pharmacy out of the total number of take home doses prescribed.
Outcome measures
| Measure |
Pharmacy-based Methadone Treatment
n=20 Participants
Participants will have their usual methadone dose administered and dispensed at a participating pharmacy. All other methadone services including counseling, drug testing, and medical services will be delivered as usual at the Methadone Program.
Pharmacy-based methadone administration and dispensing: Eligible participants receiving between 6- and 13-days of methadone take-home doses will have methadone administration and dispensing transferred from the opioid treatment program to the partnered community pharmacy. Each participant will be assessed monthly for 3 months (at 1, 2, and 3 months following intake/baseline) to explore the feasibility of transferring their methadone administration and dispensing to the select community pharmacy.
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|---|---|
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Treatment Adherence
|
100 percentage of dose adherence
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PRIMARY outcome
Timeframe: Up to 3 months per participantTreatment retention will be determined by the percentage of participants who remain in treatment at the pharmacy during the 3-month follow-up phase.
Outcome measures
| Measure |
Pharmacy-based Methadone Treatment
n=20 Participants
Participants will have their usual methadone dose administered and dispensed at a participating pharmacy. All other methadone services including counseling, drug testing, and medical services will be delivered as usual at the Methadone Program.
Pharmacy-based methadone administration and dispensing: Eligible participants receiving between 6- and 13-days of methadone take-home doses will have methadone administration and dispensing transferred from the opioid treatment program to the partnered community pharmacy. Each participant will be assessed monthly for 3 months (at 1, 2, and 3 months following intake/baseline) to explore the feasibility of transferring their methadone administration and dispensing to the select community pharmacy.
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|---|---|
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Treatment Retention
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80 percentage of participants retained
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PRIMARY outcome
Timeframe: Up to 3 months per participantPopulation: A total of 52 urine drug tests were analyzed for the 20 participants enrolled in the study.
The percentage of positive urine drug screens over the study duration will be examined.
Outcome measures
| Measure |
Pharmacy-based Methadone Treatment
n=52 Urine Drug Tests
Participants will have their usual methadone dose administered and dispensed at a participating pharmacy. All other methadone services including counseling, drug testing, and medical services will be delivered as usual at the Methadone Program.
Pharmacy-based methadone administration and dispensing: Eligible participants receiving between 6- and 13-days of methadone take-home doses will have methadone administration and dispensing transferred from the opioid treatment program to the partnered community pharmacy. Each participant will be assessed monthly for 3 months (at 1, 2, and 3 months following intake/baseline) to explore the feasibility of transferring their methadone administration and dispensing to the select community pharmacy.
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|---|---|
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Opioid and Other Substance Use
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3.8 Percentage of positive tests
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SECONDARY outcome
Timeframe: Over 3 months of treatmentParticipant satisfaction with treatment delivery will be measured on a monthly basis and a percentage of overall monthly ratings (combined) of satisfied or very satisfied will be calculated.
Outcome measures
| Measure |
Pharmacy-based Methadone Treatment
n=16 Participants
Participants will have their usual methadone dose administered and dispensed at a participating pharmacy. All other methadone services including counseling, drug testing, and medical services will be delivered as usual at the Methadone Program.
Pharmacy-based methadone administration and dispensing: Eligible participants receiving between 6- and 13-days of methadone take-home doses will have methadone administration and dispensing transferred from the opioid treatment program to the partnered community pharmacy. Each participant will be assessed monthly for 3 months (at 1, 2, and 3 months following intake/baseline) to explore the feasibility of transferring their methadone administration and dispensing to the select community pharmacy.
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|---|---|
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Treatment Satisfaction
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87.5 percentage of satisfied ratings
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SECONDARY outcome
Timeframe: Up to 3 months per participantWe will measure the prevalence of any fatal or non-fatal substance-related overdose and any substance-related emergency department visit or hospitalization.
Outcome measures
| Measure |
Pharmacy-based Methadone Treatment
n=20 Participants
Participants will have their usual methadone dose administered and dispensed at a participating pharmacy. All other methadone services including counseling, drug testing, and medical services will be delivered as usual at the Methadone Program.
Pharmacy-based methadone administration and dispensing: Eligible participants receiving between 6- and 13-days of methadone take-home doses will have methadone administration and dispensing transferred from the opioid treatment program to the partnered community pharmacy. Each participant will be assessed monthly for 3 months (at 1, 2, and 3 months following intake/baseline) to explore the feasibility of transferring their methadone administration and dispensing to the select community pharmacy.
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|---|---|
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Adverse Events
% of fatal and non-fatal overdoses
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0 percentage
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Adverse Events
% of substance-related emergency department visits or hospitalizations
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0 percentage
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SECONDARY outcome
Timeframe: 3 monthsPopulation: Participants who had methadone call back.
Percentage of participants with call backs with evidence of methadone tampering.
Outcome measures
| Measure |
Pharmacy-based Methadone Treatment
n=17 Participants
Participants will have their usual methadone dose administered and dispensed at a participating pharmacy. All other methadone services including counseling, drug testing, and medical services will be delivered as usual at the Methadone Program.
Pharmacy-based methadone administration and dispensing: Eligible participants receiving between 6- and 13-days of methadone take-home doses will have methadone administration and dispensing transferred from the opioid treatment program to the partnered community pharmacy. Each participant will be assessed monthly for 3 months (at 1, 2, and 3 months following intake/baseline) to explore the feasibility of transferring their methadone administration and dispensing to the select community pharmacy.
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|---|---|
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Percentage of Participants With Methadone Call Backs With Evidence of Tampering.
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0 Participants
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Adverse Events
Pharmacy-based Methadone Treatment
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pharmacy-based Methadone Treatment
n=20 participants at risk
Participants will have their usual methadone dose administered and dispensed at a participating pharmacy. All other methadone services including counseling, drug testing, and medical services will be delivered as usual at the Methadone Program.
Pharmacy-based methadone administration and dispensing: Eligible participants receiving between 6- and 13-days of methadone take-home doses will have methadone administration and dispensing transferred from the opioid treatment program to the partnered community pharmacy. Each participant will be assessed monthly for 3 months (at 1, 2, and 3 months following intake/baseline) to explore the feasibility of transferring their methadone administration and dispensing to the select community pharmacy.
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|---|---|
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Gastrointestinal disorders
Non-study related hospitalization for abdominal pain
|
5.0%
1/20 • Number of events 1 • 3 months
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Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place