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| ID | Type | Description | Link |
|---|---|---|---|
| 3U01DA046910-02S3 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Duke Health | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Over 3 months of treatment |
| Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Li-Tzy Wu, ScD | Duke Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Park Pharmacy | Raleigh | North Carolina | 27615 | United States | ||
| Morse Clinic of North Raleigh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34286886 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 3 months |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-study related hospitalization for abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William John, Ph.D. | Duke University | 919-681-7291 | william.john@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 2, 2021 | Nov 4, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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We will measure the prevalence of any fatal or non-fatal substance-related overdose and any substance-related emergency department visit or hospitalization. |
| Up to 3 months per participant |
| Percentage of Participants With Methadone Call Backs With Evidence of Tampering. | Percentage of participants with call backs with evidence of methadone tampering. | 3 months |
| Raleigh |
| North Carolina |
| 27615 |
| United States |
| Morse Clinic of Zebulon | Zebulon | North Carolina | 27597 | United States |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | 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. | All participants who began pharmacy-based methadone treatment. | Posted | Number | percentage of dose adherence | Up to 3 months per participant |
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| Primary | 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. | Posted | Number | percentage of participants retained | Up to 3 months per participant |
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| Primary | Opioid and Other Substance Use | The percentage of positive urine drug screens over the study duration will be examined. | A total of 52 urine drug tests were analyzed for the 20 participants enrolled in the study. | Posted | Number | Percentage of positive tests | Up to 3 months per participant | Urine Drug Tests | Urine Drug Tests |
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| Secondary | 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. | Posted | Number | percentage of satisfied ratings | Over 3 months of treatment |
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| Secondary | 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. | Posted | Number | percentage | Up to 3 months per participant |
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| Secondary | Percentage of Participants With Methadone Call Backs With Evidence of Tampering. | Percentage of participants with call backs with evidence of methadone tampering. | Participants who had methadone call back. | Posted | Count of Participants | Participants | 3 months |
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| 0 |
| 20 |
| 1 |
| 20 |
| 0 |
| 20 |
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