Interim methadone and patient navigation in jail: Rationale and design of a randomized clinical trial

Methadone maintenance is an effective treatment for opioid dependence but is rarely initiated in US jails. Patient navigation is a promising approach to improve continuity of care but has not been tested in bridging the gap between jail- and community-based drug treatment programs.

This is an open-label randomized clinical trial among 300 adult opioid dependent newly-arrested detainees that will compare three treatment conditions: methadone maintenance without routine counseling (termed Interim Methadone; IM) initiated in jail v. IM and patient navigation v. enhanced treatment-as-usual. The two primary outcomes will be: (1) the rate of entry into treatment for opioid use disorder within 30days from release and (2) frequency of opioid positive urine tests over the 12-month follow-up period. An economic analysis will examine the costs, cost-effectiveness, and cost-benefit ratio of the study interventions.

We describe the background and rationale for the study, its aims, hypotheses, and study design.

Given the large number of opioid dependent detainees in the US and elsewhere, initiating IM at the time of incarceration could be a significant public health and clinical approach to reducing relapse, recidivism, HIV-risk behavior, and criminal behavior. An economic analysis will be conducted to assist policy makers in determining the utility of adopting this approach. ClinicalTrials.gov: NCT02334215.