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

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

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.

Study Overview

• Status: Completed
• Conditions: Opioid-use Disorder
• Intervention / Treatment: Drug: Pharmacy-based methadone administration and dispensing

Detailed Description

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
• Enrollment (Actual): 20
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Raleigh, North Carolina, United States, 27615
      • Health Park Pharmacy
    • Raleigh, North Carolina, United States, 27615
      • Morse Clinic of North Raleigh
    • Zebulon, North Carolina, United States, 27597
      • Morse Clinic of Zebulon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Drug: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Friends Research Institute, Inc.
• Collaborators: National Institute on Drug Abuse (NIDA); Duke Health
• Investigators: Principal Investigator: Li-Tzy Wu, ScD, Duke Health

Publications and helpful links

General Publications

• Wu LT, John WS, Morse ED, Adkins S, Pippin J, Brooner RK, Schwartz RP. Opioid treatment program and community pharmacy collaboration for methadone maintenance treatment: results from a feasibility clinical trial. Addiction. 2022 Feb;117(2):444-456. doi: 10.1111/add.15641. Epub 2021 Aug 16.

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2020
• Primary Completion (Actual): January 5, 2021
• Study Completion (Actual): January 18, 2021

Study Registration Dates

• First Submitted: March 10, 2020
• First Submitted That Met QC Criteria: March 13, 2020
• First Posted (Actual): March 16, 2020

Study Record Updates

• Last Update Posted (Actual): April 1, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Respiratory System Agents; Antitussive Agents; Methadone
• Other Study ID Numbers: Pro00103270; 3U01DA046910-02S3 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No