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A Nested Sequence of 3 Randomized Trials

Stephanie S. O'Malley, PhD; Bruce J. Rounsaville, MD; Conor Farren, MD, PhD; Kee Namkoong, MD; Ran Wu, MS; Jane Robinson, PsyD; Patrick G. O'Connor, MD, MPH

Arch Intern Med. 2003;163:1695-1704.

Background  Naltrexone may improve success in primary care treatment of alcohol dependence (AD). This study tests naltrexone and primary care management (PCM) vs naltrexone and cognitive behavior therapy (CBT) and tests naltrexone maintenance among patients who respond to an initial course of naltrexone combined with PCM vs CBT.

Methods  A nested sequence of 3 randomized trials was conducted. In study 1, 197 subjects with AD participated in a 10-week comparison of PCM and naltrexone (50 mg/d) vs CBT and naltrexone (50 mg/d). In study 2, 53 PCM responders from study 1 continued in a 24-week placebo-controlled study of maintenance naltrexone. In study 3, 60 CBT responders from study 1 continued in a 24-week placebo-controlled study of maintenance naltrexone and CBT.

Results  Study 1: No difference in the response to treatment; 84.1% (74/88) of the PCM patients and 86.5% (77/89) of the CBT patients avoided persistent heavy drinking. Percentage of days abstinent (PDA) declined over time for PCM vs CBT (P = .03). Study 2: Higher response maintenance for PCM and naltrexone (21/26, 80.8%) vs PCM and placebo (14/27, 51.9%; P = .03) and PDA declined more for the placebo group (P = .02). Study 3: The differences between naltrexone vs placebo on maintenance of response (25/30, 83.3% vs 21/30, 70.0%) or PDA did not reach statistical significance.

Conclusions  Naltrexone yielded comparable results during the initial 10 weeks of treatment when combined with PCM or CBT. Maintenance of improvement was enhanced by continued naltrexone treatment in the PCM but not in the CBT arm.

From the Departments of Psychiatry (Drs O'Malley, Rounsaville, Farren, and Robinson and Ms Wu) and Internal Medicine (Dr O'Connor), Yale University School of Medicine, New Haven, Conn; the Department of Psychiatry, Mount Sinai School of Medicine, New York, NY (Dr Farren); and Department of Psychiatry, Yonsei University College of Medicine, Seoul, Korea (Dr Namkoong). Dr Farren is now with the Department of Addiction Psychiatry, St Patrick's Hospital, Dublin, Ireland. Dr O'Malley has previously served as a consultant, Drs O'Malley and Farren have previously received research support, and Drs O'Malley, Rounsaville, and Farren have previously served as speakers for Dupont Merck Pharmaceutical Company.

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