Status:
COMPLETED
Opioid Treatment Program (OTP)-Pharmacy Collaboration for Methadone Maintenance Treatment
Lead Sponsor:
Friends Research Institute, Inc.
Collaborating Sponsors:
Duke Health
National Institute on Drug Abuse (NIDA)
Conditions:
Opioid-use Disorder
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 dis...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 18 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04308694
Start Date
August 6 2020
End Date
January 18 2021
Last Update
April 1 2022
Active Locations (3)
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1
Health Park Pharmacy
Raleigh, North Carolina, United States, 27615
2
Morse Clinic of North Raleigh
Raleigh, North Carolina, United States, 27615
3
Morse Clinic of Zebulon
Zebulon, North Carolina, United States, 27597