Open-Label Study of a Proprietary Treatment Program Targeting Type A γ-Aminobutyric Acid Receptor Dysregulation in Methamphetamine Dependence

OBJECTIVE To evaluate the safety and efficacy of the pharmacological component of a proprietary medical treatment program targeting type A γ-aminobutyric acid receptor dysregulation in adults who met the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision criteria for methamphetamine dependence. PARTICIPANTS AND METHODS A prospective, open-label, single-group study of the medication portion of a proprietary treatment program for methamphetamine dependence was conducted from July 1, 2005, to May 10, 2006, at Research Across America, an outpatient private, for-profit, clinical research company in Dallas, TX. In the study, flumazenil, hydroxyzine, and gabapentin, all of which were approved by the US Food and Drug Administration for indications other than drug dependence, were used off-label for the treatment of methamphetamine dependence. Fifty persons who had used methamphetamine within 7 days of study entry were enrolled and received the treatment. Treatment lasted 4 weeks, followed by 8 weeks of weekly follow-up visits to monitor for methamphetamine use via urine drug tests and self-reporting. RESULTS Participant retention was higher than expected, with 85% of participants completing the program. Significant decrease in methamphetamine use ( P