The overarching goal of this pilot study is to explore the feasibility, acceptability, and patient/provider satisfaction of pharmacy-based administration and dispensing of methadone for opioid use disorder. The results gained will inform the development of a future multisite randomized clinical trial.
The study will use a non-randomized, prospective, single group design. Twenty long-term, clinically-stable methadone maintenance treatment (MMT) patients who receive between 6- and 13-days methadone take-home doses will be enrolled in the study where their methadone take-home administration and dispensing will be transferred to a community pharmacy for 3 months. Participants will also complete three follow-up assessments at 1-month, 2-months, and 3-months after the baseline visit to collect clinical and safety information since the previous assessment. Primary outcomes will be focused on feasibility measures (recruitment, accessibility to methadone treatment, substance use, medication call back success, and retention in treatment). Secondary outcomes will be focused on self-reported satisfaction measures from MMT providers (e.g., physician, physician assistant, nurse, and counselor) pharmacists, and patient participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
20
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.
Health Park Pharmacy
Raleigh, North Carolina, United States
Morse Clinic of North Raleigh
Raleigh, North Carolina, United States
Morse Clinic of Zebulon
Zebulon, North Carolina, United States
Recruitment Rate
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.
Time frame: 3 months
Treatment Adherence
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.
Time frame: Up to 3 months per participant
Treatment Retention
Treatment retention will be determined by the percentage of participants who remain in treatment at the pharmacy during the 3-month follow-up phase.
Time frame: Up to 3 months per participant
Opioid and Other Substance Use
The percentage of positive urine drug screens over the study duration will be examined.
Time frame: Up to 3 months per participant
Treatment Satisfaction
Participant 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.
Time frame: Over 3 months of treatment
Adverse Events
We will measure the prevalence of any fatal or non-fatal substance-related overdose and any substance-related emergency department visit or hospitalization.
Time frame: Up to 3 months per participant
Percentage of Participants With Methadone Call Backs With Evidence of Tampering.
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Percentage of participants with call backs with evidence of methadone tampering.
Time frame: 3 months