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

NCT04308694 | Completed Early Phase 1 Results FDA Drug

• 2 other identifiers: Pro001032703U01DA046910-02S3
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

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.

Conditions

Opioid-use Disorder

Outcome Measures

Primary Outcomes (4)

• Recruitment Rate

  The recruitment rate will be assessed on a monthly basis (e.g, Month 1, 2 and 3) until the enrollment target is reached. The recruitment rate is operationalized as the total number of participants consented in one month.

  3 months

• Treatment Adherence

  Adherence to pharmacy-based methadone treatment will be defined as the percentage of methadone take-home doses dispensed at the pharmacy out of the total number of take home doses prescribed.

  Up to 3 months per participant

• Treatment Retention

  Treatment retention will be determined by the percentage of participants who remain in treatment at the pharmacy during the 3-month follow-up phase.

  Up to 3 months per participant

• Opioid and Other Substance Use

  The percentage of positive urine drug screens over the study duration will be examined.

  Up to 3 months per participant

Secondary Outcomes (3)

• Treatment Satisfaction

  Over 3 months of treatment

• Adverse Events

  Up to 3 months per participant

• Percentage of Participants With Methadone Call Backs With Evidence of Tampering.

  3 months

Study Arms (1)

Pharmacy-based methadone treatment

EXPERIMENTAL

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.

Drug: Pharmacy-based methadone administration and dispensing

Interventions

Pharmacy-based methadone administration and dispensing 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.

Pharmacy-based methadone treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Friends Research Institute, Inc.: lead
• Duke Health: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (3)

Health Park Pharmacy

Raleigh, North Carolina, 27615, United States

Location

Morse Clinic of North Raleigh

Raleigh, North Carolina, 27615, United States

Location

Morse Clinic of Zebulon

Zebulon, North Carolina, 27597, United States

Location

Related Publications (1)

• 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.

  PMID: 34286886 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: William John, Ph.D.
• Organization: Duke University

william.john@duke.edu

919-681-7291

Study Officials

• Li-Tzy Wu, ScD

  Duke Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 16, 2020
• Study Start: August 6, 2020
• Primary Completion: January 5, 2021
• Study Completion: January 18, 2021
• Last Updated: April 1, 2022
• Results First Posted: December 2, 2021

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)