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.
Friends Research Institute, Baltimore, MD, USA. Electronic address: rschwartz@friendsresearch.org.
Robert P
RP
Schwartz
Friends Research Institute, Baltimore, MD, USA.
Sharon M
SM
Kelly
Friends Research Institute, Baltimore, MD, USA.
Shannon G
SG
Mitchell
RTI International, Research Triangle Park, NC, USA.
Laura
L
Dunlap
RTI International, Research Triangle Park, NC, USA.
Gary A
GA
Zarkin
Friends Research Institute, Baltimore, MD, USA.
Anjalee
A
Sharma
Department of Psychology, University of Maryland, College Park, College Park, MD, USA.
Kevin E
KE
O'Grady
Friends Research Institute, Baltimore, MD, USA; Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA.
Jerome H
JH
Jaffe
D000701:Analgesics, Opioid / Q000627:therapeutic use*; D003153:Community Health Services; D003362:Cost-Benefit Analysis; D003365:Costs and Cost Analysis; D005260:Female; D006801:Humans; D008297:Male; D008691:Methadone / Q000627:therapeutic use*; D058850:Opiate Substitution Treatment / Q000191:economics / Q000379:methods*; D009293:Opioid-Related Disorders / Q000188:drug therapy*; D062526:Patient Navigation / Q000191:economics / Q000379:methods*; D010360:Patient Transfer; D011330:Prisons; D014481:United States
D000701:Analgesics, Opioid; D008691:Methadone
Criminal justice; Interim methadone; Jail; Methadone treatment; Patient navigation