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

Completed · Early Phase 1

Conditions studied: Opioid-use Disorder

In brief

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.

Key facts

Study ID

NCT04308694

Run by

Friends Research Institute, Inc.

People needed

20

Starts

2020-08-06

Expected to finish

2021-01-18

Last updated by the study team

2022-04-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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