Opioid-use Disorder
Conditions
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.
Interventions
DRUGPharmacy-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.
Sponsors
Duke Health
National Institute on Drug Abuse (NIDA)
Friends Research Institute, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Percentage of Participants With Methadone Call Backs With Evidence of Tampering. | 3 months | Percentage of participants with call backs with evidence of methadone tampering. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Pharmacy-based Methadone Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 1 / 20 |
Outcome results
Primary
Opioid and Other Substance Use
The percentage of positive urine drug screens over the study duration will be examined.
Time frame: Up to 3 months per participant
Population: A total of 52 urine drug tests were analyzed for the 20 participants enrolled in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pharmacy-based Methadone Treatment | Opioid and Other Substance Use | 3.8 Percentage of positive tests |
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.
Time frame: 3 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pharmacy-based Methadone Treatment | Recruitment Rate | Month 1 | 3 Participants |
| Pharmacy-based Methadone Treatment | Recruitment Rate | Month 2 | 12 Participants |
| Pharmacy-based Methadone Treatment | Recruitment Rate | Month 3 | 5 Participants |
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.
Time frame: Up to 3 months per participant
Population: All participants who began pharmacy-based methadone treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pharmacy-based Methadone Treatment | Treatment Adherence | 100 percentage of dose adherence |
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.
Time frame: Up to 3 months per participant
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pharmacy-based Methadone Treatment | Treatment Retention | 80 percentage of participants retained |
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.
Time frame: Up to 3 months per participant
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pharmacy-based Methadone Treatment | Adverse Events | % of fatal and non-fatal overdoses | 0 percentage |
| Pharmacy-based Methadone Treatment | Adverse Events | % of substance-related emergency department visits or hospitalizations | 0 percentage |
Secondary
Percentage of Participants With Methadone Call Backs With Evidence of Tampering.
Percentage of participants with call backs with evidence of methadone tampering.
Time frame: 3 months
Population: Participants who had methadone call back.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pharmacy-based Methadone Treatment | Percentage of Participants With Methadone Call Backs With Evidence of Tampering. | 0 Participants |
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.
Time frame: Over 3 months of treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pharmacy-based Methadone Treatment | Treatment Satisfaction | 87.5 percentage of satisfied ratings |