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Rationale and design of a randomized clinical trial
Schwartz, R. P., Kelly, S. M., Mitchell, S. G., Dunlap, L., Zarkin, G., Sharma, A., O'Grady, K. E., & Jaffe, J. H. (2016). Interim methadone and patient navigation in jail: Rationale and design of a randomized clinical trial. Contemporary Clinical Trials, 49, 21-28. https://doi.org/10.1016/j.cct.2016.06.002
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.
