# Facilitating the Implementation of Interim Methadone to Increase Treatment Access: A Multi-Site Implementation Trial

> **NIH NIH U01** · FRIENDS RESEARCH INSTITUTE, INC. · 2020 · $564,331

## Abstract

The US is facing an unprecedented opioid epidemic. Methadone treatment is effective in reducing illicit opioid
use and overdose death, yet waiting lists for Opioid Treatment Programs (OTPs) persist in numerous states.
Federal regulations since 1993 permit the provision of interim methadone (IM) treatment – consisting of
supervised methadone administration without routine counseling – for up to 120 days for people on OTP
waiting lists. IM is on federal Substance Abuse and Mental Health Services Administration’s National Registry
of Evidence-based Programs and Practices. Two randomized trials, including one conducted by our team,
have shown that IM treatment is more effective than waiting list in increasing OTP admission and reducing illicit
opioid use. Our team led the successful implementation and evaluation of IM in six Baltimore OTPs for 1,000
patients over an 18-month period. The Center for Substance Abuse Treatment recently commissioned the PI to
author a white paper on IM that found barriers to the implementation of IM include lack of awareness and
misconceptions about IM among some State Opioid Treatment Authorities (SOTAs) who must recommend its
approval and OTP Directors who must implement it. Despite the ongoing opioid epidemic, IM’s effectiveness,
and the persistence of OTP waiting lists, IM has rarely been used outside of research. Research is needed to
find an effective approach to spur IM’s implementation. This application proposes a Type 3 implementation
effectiveness study using a stepped-wedge randomized trial design in the context of Proctor’s implementation
model. This study will adapt, deploy, and assess the effectiveness of an Implementation Facilitation strategy to
spur the use of IM treatment. In this strategy, the PI will serve as the external facilitator to work with the
National Association of State Alcohol and Drug Abuse Directors to co-lead a learning collaborative for
participating SOTAs and OTP leadership of nine participating OTPs with waiting lists. Local OTP champions
will be recruited and the PI will provide academic detailing, IM procedures training, and performance feedback
to OTP staff. The IM operations manual from the team’s previous work will be used to train OTP staff. The
Implementation Facilitation intervention will occur in 9 OTPs, and will include data collection for an estimated
6,120 adults on OTP waiting lists and 1,710 IM treatment admissions. The primary implementation outcome
(Accessibility to methadone treatment), as well as secondary implementation (Uptake, Efficiency, Fidelity,
Sustainability, Feasibility, and Acceptability) and clinical effectiveness (urine opioid testing results) outcomes
will be measured using a combination of de-identified OTP data and qualitative SOTA and OTP staff semi-
structured interviews. The proposed study is highly significant because it could demonstrate an effective
approach to spur the implementation of IM treatment to reduce OTP waiting lists. This study is inno...

## Key facts

- **NIH application ID:** 9979810
- **Project number:** 5U01DA046910-03
- **Recipient organization:** FRIENDS RESEARCH INSTITUTE, INC.
- **Principal Investigator:** ROBERT P SCHWARTZ
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $564,331
- **Award type:** 5
- **Project period:** 2018-09-30 → 2022-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9979810

## Citation

> US National Institutes of Health, RePORTER application 9979810, Facilitating the Implementation of Interim Methadone to Increase Treatment Access: A Multi-Site Implementation Trial (5U01DA046910-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9979810. Licensed CC0.

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