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Open-Label Pilot Study of Extended-Release Naltrexone to Reduce Drinking and Driving Among Repeat Offenders

Lapham, Sandra C. MD, MPH, FASAM; McMillan, Garnett P. PhD

doi: 10.1097/ADM.0b013e3181eb3b89
Original Research

Objectives: A high proportion of persons convicted of driving while impaired repeat the offense. Many continue drinking and driving, even when faced with long jail terms. Hence, they pose a serious public health threat. This preliminary study evaluated extended-release, injectable naltrexone suspension (XR-NTX) and supportive therapy in reducing (1) drinking and (2) attempts to drive after drinking among repeat driving while impaired offenders with an ignition interlock device installed in their vehicles.

Methods: Treatment-seeking volunteers received medical management therapy and 3 monthly injections of XR-NTX. We compared data on alcohol consumption, alcohol biomarkers, and interlock information before, during, and after treatment using summary measures and Sign tests.

Results: Of 12 consented subjects, 10 received at least 1 injection, and 7 received all 3 injections. All subjects receiving medication reported a decrease in average drinks per day (P < 0.01) and abstinent days (P = 0.02) while on treatment versus pretreatment levels. Average daily drinks decreased by 77%, from 3.0 to 0.69 (P < 0.01), during treatment with XR-NTX. Average drinks per drinking day also declined by 39% during treatment, from 6.6 to 4.0 (P = 0.04). Percent days abstinent increased by 31%, from 56.8 to 81.96 (P = 0.02), which persisted after treatment completion. Biomarkers were consistent with reduced drinking. The percentage of vehicular failures to start due to elevated breath alcohol decreased from 3.1% of tests to 1.29% of tests.

Conclusions: A randomized, controlled clinical trial is needed to demonstrate the efficacy of this promising treatment regimen for repeat offenders.

From the Behavioral Health Research Center of the Southwest, Pacific Institute for Research and Evaluation, Albuquerque, NM.

Send correspondence and reprint requests to Sandra C. Lapham, MD, MPH, FASAM, Behavioral Health Research Center of the Southwest, 612 Encino Place NE, Albuquerque, NM 87102. e-mail:

Supported by Alkermes, Inc., grant number ALKISS LAP-002.

Received March 19, 2010

Accepted June 03, 2010

© 2011 American Society of Addiction Medicine