Clinical trial NCT04308694: Opioid Treatment Program (OTP)-Pharmacy Collaboration for Methadone Maintenance Treatment
Official title: A Pilot Study to Permit Opioid Treatment Program Physicians to Prescribe Methadone Through Community Pharmacies for Their Stable Methadone Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Opioid-use Disorder
Lead sponsor: Friends Research Institute, Inc.
Sponsor class: OTHER
Collaborators: name: Duke Health
name: National Institute on Drug Abuse (NIDA)
First posted: 2020-03-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recruitment Rate
timeFrame: 3 months
measure: Treatment Adherence
timeFrame: Up to 3 months per participant
measure: Treatment Retention
timeFrame: Up to 3 months per participant
measure: Opioid and Other Substance Use
timeFrame: Up to 3 months per participant
Secondary outcomes:
measure: Treatment Satisfaction
timeFrame: Over 3 months of treatment
measure: Adverse Events
timeFrame: Up to 3 months per participant
measure: Percentage of Participants With Methadone Call Backs With Evidence of Tampering.
timeFrame: 3 months
Other outcomes:
Locations:
city: Raleigh
country: United States
facility: Health Park Pharmacy
state: North Carolina
city: Raleigh
country: United States
facility: Morse Clinic of North Raleigh
state: North Carolina
city: Zebulon
country: United States
facility: Morse Clinic of Zebulon
state: North Carolina
Study officials:
affiliation: Duke Health
name: Li-Tzy Wu, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.