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

NCT ID: NCT04308694

Last Updated: 2022-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-06
• Study Completion Date: 2021-01-18

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.

Conditions

Opioid-use Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Pharmacy-based methadone administration and dispensing

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duke Health

OTHER

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Friends Research Institute, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Li-Tzy Wu, ScD

Role: PRINCIPAL_INVESTIGATOR

Duke Health

Locations

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

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34286886 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

3U01DA046910-02S3

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00103270

Identifier Type: -

Identifier Source: org_study_id