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

Contemp Clin Trials. 2016 Jul:49:21-8. doi: 10.1016/j.cct.2016.06.002. Epub 2016 Jun 7.

Abstract

Background: 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.

Methods: 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.

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

Conclusions: 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.

Keywords: Criminal justice; Interim methadone; Jail; Methadone treatment; Patient navigation.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Analgesics, Opioid / therapeutic use*
  • Community Health Services*
  • Cost-Benefit Analysis
  • Costs and Cost Analysis
  • Female
  • Humans
  • Male
  • Methadone / therapeutic use*
  • Opiate Substitution Treatment / economics
  • Opiate Substitution Treatment / methods*
  • Opioid-Related Disorders / drug therapy*
  • Patient Navigation / economics
  • Patient Navigation / methods*
  • Patient Transfer
  • Prisons*
  • United States

Substances

  • Analgesics, Opioid
  • Methadone

Associated data

  • ClinicalTrials.gov/NCT02334215