Opioid-use DisorderEarly Phase 1NCT04308694
Opioid Treatment Program (OTP)-Pharmacy Collaboration for Methadone Maintenance Treatment
A Early Phase 1 study testing Pharmacy-based methadone administration and dispensing in people with Opioid-use Disorder, run by Friends Research Institute, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- Pharmacy-based methadone administration and dispensing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- 6 Aug 2020to 18 Jan 2021
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Health Park Pharmacy
Raleigh, North Carolina, 27615
Morse Clinic of North Raleigh
Raleigh, North Carolina, 27615
Morse Clinic of Zebulon
Zebulon, North Carolina, 27597
About this study
Official title: A Pilot Study to Permit Opioid Treatment Program Physicians to Prescribe Methadone Through Community Pharmacies for Their Stable Methadone Patients
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.
Read the 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
- Being tested
- Pharmacy-based methadone administration and dispensing
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacy-based methadone administration and dispensingDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Pharmacy-based methadone administration and dispensing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 3 months per participant
Secondary outcomes (3)
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.
Measured: Over 3 months of treatment
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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start6 Aug 2020
- Primary completion5 Jan 2021
- Study completion18 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Friends Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Duke Health, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Li-Tzy Wu, ScD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04308694
- Sponsor's protocol ID
- Pro00103270
- Other IDs
- 3U01DA046910-02S3
- Status last verified
- Mar 2022
- First submitted
- 10 Mar 2020
- Last updated
- 1 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34286886
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Permit Opioid Treatment Program Physicians to Prescribe Methadone Through Community Pharmacies for Their Stable Methadone Patients
- ClinicalTrials.gov ID
- NCT04308694
- Acronym / sponsor ID
- Pro00103270
- Conditions
- Opioid-use Disorder
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Friends Research Institute, Inc.University, hospital or other
- Collaborators
- Duke Health, National Institute on Drug Abuse (NIDA)
- Study start
- 6 Aug 2020 (actual)
- Primary completion
- 5 Jan 2021 (actual)
- Study completion
- 18 Jan 2021 (actual)
- First posted
- 16 Mar 2020 (actual)
- Results
- Posted 2 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pharmacy-based methadone treatment | Experimental | Drug: Pharmacy-based methadone administration and dispensingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacy-based methadone administration and dispensingEligible 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. | Drug | Pharmacy-based methadone treatment |
Primary outcome
Recruitment Rate
Time frame: 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.
Treatment Adherence
Time frame: 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.
Treatment Retention
Time frame: 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.
Opioid and Other Substance Use
Time frame: Up to 3 months per participant
The percentage of positive urine drug screens over the study duration will be examined.
3 secondary outcomes
Treatment Satisfaction
Time frame: Over 3 months of treatment
Adverse Events
Time frame: Up to 3 months per participant
Percentage of Participants With Methadone Call Backs With Evidence of Tampering.
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34286886Wu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li-Tzy Wu, ScD principal investigator
Duke Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Pharmacy-based methadone administration and dispensing in people with Opioid-use Disorder, run by Friends Research Institute, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04308694, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.