Early Phase 1
Completed N=20
Opioid Treatment Program (OTP)-Pharmacy Collaboration for Methadone Maintenance Treatment
Source: ClinicalTrials.gov NCT04308694 ↗Enrolled (actual)
20
Serious AEs
5.0%
Results posted
Dec 2021
Primary outcomePrimary: Recruitment Rate — 3; 12; 5 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recruitment Rate |
3; 12; 5 | — |
| PRIMARY Treatment Adherence |
100 | — |
| PRIMARY Treatment Retention |
80 | — |
| PRIMARY Opioid and Other Substance Use |
3.8 | — |
| SECONDARY Treatment Satisfaction |
87.5 | — |
| SECONDARY Adverse Events |
0; 0 | — |
| SECONDARY Percentage of Participants With Methadone Call Backs With Evidence of Tampering. |
— | — |
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.
Data sourced from ClinicalTrials.gov (NCT04308694). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.