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

Primary Purpose

Opioid-use Disorder

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Pharmacy-based methadone administration and dispensing

About this trial

This is an interventional health services research trial for Opioid-use Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

Health Park Pharmacy
Morse Clinic of North Raleigh
Morse Clinic of Zebulon

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pharmacy-based methadone treatment

Arm 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.

Outcomes

Primary Outcome Measures

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.

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.

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.

Opioid and Other Substance Use

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

Secondary Outcome Measures

Treatment Satisfaction

Participant satisfaction with treatment delivery will be measured on a monthly basis and a percentage of overall monthly ratings (combined) of satisfied or very satisfied will be calculated.

Adverse Events

We will measure the prevalence of any fatal or non-fatal substance-related overdose and any substance-related emergency department visit or hospitalization.

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

Percentage of participants with call backs with evidence of methadone tampering.

Full Information

NCT ID

NCT04308694

First Posted

March 10, 2020

Last Updated

March 8, 2022

Sponsor

Friends Research Institute, Inc.

Collaborators

Duke Health, National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT04308694

Brief Title

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

Official Title

A Pilot Study to Permit Opioid Treatment Program Physicians to Prescribe Methadone Through Community Pharmacies for Their Stable Methadone Patients

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

August 6, 2020 (Actual)

Primary Completion Date

January 5, 2021 (Actual)

Study Completion Date

January 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Friends Research Institute, Inc.

Collaborators

Duke Health, National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Opioid-use Disorder

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pharmacy-based methadone treatment

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Pharmacy-based methadone administration and dispensing

Intervention Description

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.

Primary Outcome Measure Information:

Title

Recruitment Rate

Description

Time Frame

3 months

Title

Treatment Adherence

Description

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.

Time Frame

Up to 3 months per participant

Title

Treatment Retention

Description

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

Time Frame

Up to 3 months per participant

Title

Opioid and Other Substance Use

Description

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

Time Frame

Up to 3 months per participant

Secondary Outcome Measure Information:

Title

Treatment Satisfaction

Description

Participant satisfaction with treatment delivery will be measured on a monthly basis and a percentage of overall monthly ratings (combined) of satisfied or very satisfied will be calculated.

Time Frame

Over 3 months of treatment

Title

Adverse Events

Description

We will measure the prevalence of any fatal or non-fatal substance-related overdose and any substance-related emergency department visit or hospitalization.

Time Frame

Up to 3 months per participant

Title

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

Description

Percentage of participants with call backs with evidence of methadone tampering.

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Li-Tzy Wu, ScD

Organizational Affiliation

Duke Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Health Park Pharmacy

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27615

Country

United States

Facility Name

Morse Clinic of North Raleigh

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27615

Country

United States

Facility Name

Morse Clinic of Zebulon

City

Zebulon

State/Province

North Carolina

ZIP/Postal Code

27597

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34286886

Citation

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.

Results Reference

derived

Learn more about this trial

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

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