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

• Sponsor: Friends Research Institute, Inc. (Other)
• Overall Status: Completed
• CT.gov ID: NCT04308694
• Collaborator: Duke Health (Other), National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 20
• Locations: 3
• Arm: 1
• Actual Duration (Months): 5.4
• Patients Per Site: 6.7
• Patients Per Site Per Month: 1.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Opioid-use Disorder	Drug: Pharmacy-based methadone administration and dispensing	Early Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: A Pilot Study to Permit Opioid Treatment Program Physicians to Prescribe Methadone Through Community Pharmacies for Their Stable Methadone Patients
• Actual Study Start Date: Aug 6, 2020
• Actual Primary Completion Date: Jan 5, 2021
• Actual Study Completion Date: Jan 18, 2021

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 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.

Drug: 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.

Outcome Measures

Primary Outcome Measures

1. Recruitment Rate [3 months]

   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.

2. Treatment Adherence [Up to 3 months per participant]

   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.

3. Treatment Retention [Up to 3 months per participant]

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

4. Opioid and Other Substance Use [Up to 3 months per participant]

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

Secondary Outcome Measures

1. Treatment Satisfaction [Over 3 months of treatment]

   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.

2. Adverse Events [Up to 3 months per participant]

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

3. Percentage of Participants With Methadone Call Backs With Evidence of Tampering. [3 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Li-Tzy Wu, ScD, Duke Health

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 2, 2021

More Information

Publications

None provided.

• Responsible Party: Friends Research Institute, Inc.
• ClinicalTrials.gov Identifier: NCT04308694
• Other Study ID Numbers: Pro00103270; 3U01DA046910-02S3
• First Posted: Mar 16, 2020
• Last Update Posted: Apr 1, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Opioid-Related Disorders; Methadone

Study Results

Participant Flow

Arm/Group Title	Pharmacy-based Methadone Treatment
Arm/Group 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. 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.
Period Title: Overall Study
STARTED	20
COMPLETED	16
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	Pharmacy-based Methadone Treatment
Arm/Group 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. 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.
Overall Participants	20
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	20 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	14 70%
Male	6 30%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 5%
White	18 90%
More than one race	0 0%
Unknown or Not Reported	1 5%
Region of Enrollment (participants) [Number]
United States	20 100%

Outcome Measures

1. Primary Outcome

Title	Recruitment Rate
Description	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.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pharmacy-based Methadone Treatment
Arm/Group 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. 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.
Measure Participants	20
Month 1	3 15%
Month 2	12 60%
Month 3	5 25%

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants who began pharmacy-based methadone treatment.

Arm/Group Title	Pharmacy-based Methadone Treatment
Arm/Group 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. 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.
Measure Participants	20
Number [percentage of dose adherence]	100

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pharmacy-based Methadone Treatment
Arm/Group 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. 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.
Measure Participants	20
Number [percentage of participants retained]	80 400%

4. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

A total of 52 urine drug tests were analyzed for the 20 participants enrolled in the study.

Arm/Group Title	Pharmacy-based Methadone Treatment
Arm/Group 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. 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.
Measure Participants	20
Measure Urine Drug Tests	52
Number [Percentage of positive tests]	3.8

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pharmacy-based Methadone Treatment
Arm/Group 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. 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.
Measure Participants	16
Number [percentage of satisfied ratings]	87.5

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pharmacy-based Methadone Treatment
Arm/Group 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. 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.
Measure Participants	20
% of fatal and non-fatal overdoses	0
% of substance-related emergency department visits or hospitalizations	0

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Participants who had methadone call back.

Arm/Group Title	Pharmacy-based Methadone Treatment
Arm/Group 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. 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.
Measure Participants	17
Count of Participants [Participants]	0 0%

Adverse Events

Time Frame	3 months
Arm/Group Title	Pharmacy-based Methadone Treatment
Arm/Group 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. 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.
All Cause Mortality
	Pharmacy-based Methadone Treatment
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Serious Adverse Events
	Pharmacy-based Methadone Treatment
	Affected / at Risk (%)	# Events
Total	1/20 (5%)
Gastrointestinal disorders
Non-study related hospitalization for abdominal pain	1/20 (5%)	1
Other (Not Including Serious) Adverse Events
	Pharmacy-based Methadone Treatment
	Affected / at Risk (%)	# Events
Total	0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.