0330 Blinded Verses Open-Label Hypnotic Tapering for Hypnotic Discontinuation: A Randomized Clinical Trial

Abstract

Abstract Introduction Many patients have difficulties achieving hypnotic discontinuation due to anxiety that arises when they knowingly reduce their hypnotic dose or withhold it entirely. This study is testing a blinded tapering approach designed to reduce patients’ anxiety during the hypnotic tapering process. Methods Thus far, a sample of 44 (M age = 59.1±14.1 yrs.; 61.4% women) users of benzodiazepine (BZD) or newer generation benzodiazepine receptor agonists (BZRA) have enrolled in this trial and completed a 3-month post-tapering follow-up. Following baseline assessments that included completion of the insomnia severity index (ISI), these enrollees completed 4 sessions of cognitive behavioral insomnia therapy (CBTI). Subsequently they were randomized to one of two 10-week, tapering protocols wherein their medication dosage was reduced by 25% every two weeks either in a blinded or open-label manner. Medication usage was assessed and ISI scores were obtained at the end of the tapering phase and at a 3-month follow-up. Results A linear mixed model analysis showed only an effect for time in study on ISI scores with both tapering groups showing a significant (F = 36.89; p = .0001) decline in these scores from baseline through the 3-month follow-up. By the 3-month follow-up, a slightly, albeit non-significantly, higher proportion of the blinded tapering group (76.2%) were no longer using their BZD/BZRA hypnotics than in the open label group (60.9%). However, there was a significantly higher BZD/BZRA discontinuation rate by the 3-month follow-up among those who achieved ISI score-determined insomnia remission than among unremitted participants both for the sample as a whole (85% vs. 54.2%; p = .05) and for the open label group (88.9% vs. 42.9%; p = .0397) considered separately. This difference between remitted and unremitted participants was not seen in the blinded tapering group. Conclusion Early findings in this trial suggest a slight advantage to blinded over open label hypnotic tapering in achieving hypnotic discontinuation. Moreover, insomnia remission may not be essential for hypnotic discontinuation when blinded tapering is conducted. Support (if any) National Institute of Drug Abuse, Grant # 1R01DA047341-01A1