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

Friends Research Institute

Status and phase: Completed; Early Phase 1

Conditions: Opioid-use Disorder

Treatments: Drug: Pharmacy-based methadone administration and dispensing

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04308694

3U01DA046910-02S3 (U.S. NIH Grant/Contract)

Pro00103270

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

Pharmacy-based methadone treatment

Experimental group

Description:

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.

Treatment:

Drug: Pharmacy-based methadone administration and dispensing