Opioid Treatment Program (OTP)-Pharmacy Collaboration for Methadone Maintenance Treatment

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pilot Study to Permit Opioid Treatment Program Physicians to Prescribe Methadone Through Community Pharmacies for Their Stable Methadone Patients

Conditions
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Opioid-use Disorder

Intervention / Treatment
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* Drug: Pharmacy-based methadone administration and dispensing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient aged 18 or older receiving methadone treatment at Morse Clinic in Raleigh or Zebulon, NC. Able to provide informed written consent to participate in the pilot study. Receiving a stable methadone dose between 5 mg and 160 mg. Having all negative drug tests (except for prescribed methadone and ethanol) at the OTP for the past 12 months. No missed call-backs in the past 12 months. No signs/symptoms of a co-occurring major mental illness (i.e., thought disorder, thoughts of harm to self or others, delusions or hallucinations, cognitive impairment compromising informed consent to study procedures and requirements). Meeting the federal and state regulations for eligibility to receive between 6- and 13-days of take-home methadone and receiving this level of take-home doses at the time of study enrollment. If female, using adequate birth control methods. Exclusion Criteria: Have a serious medical, psychiatric or substance use disorder that, in the opinion of the study physician, would make study participation hazardous to the participant, compromise study findings, or prevent the participant from completing the study. Have chronic pain requiring ongoing pain management with opioid analgesics. Prisoner status or pending legal action that could prevent participation in study activities Legal order for treatment (e.g., parole, probation, or pre-trial) Pregnant or breastfeeding at the time of screening.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmacy-based methadone treatment<br>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. | Drug: Pharmacy-based methadone administration and dispensing<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | Up to 3 months per participant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Up to 3 months per participant | 
| Percentage of Participants With Methadone Call Backs With Evidence of Tampering. | Percentage of participants with call backs with evidence of methadone tampering. | 3 months |