Benzodiazepine Dependence | Gabapentin Treatment of Benzodiazepine Dependence
Benzodiazepine Dependence research study
What is the primary objective of this study?
Benzodiazepine dependence is a growing public health problem for which very few evidenced-based treatment approaches are available. Approximately 683,000 individuals met past year criteria for sedative-hypnotic use disorders in the US during 2010, a prevalence greater than heroin or methamphetamine dependence. The most commonly prescribed sedative-hypnotic agents are the benzodiazepines. Chronic use induces pharmacodynamic tolerance in the GABA neurotransmitter system and individuals with physiological dependence find benzodiazepines difficult to discontinue because of withdrawal or rebound symptoms, which include autonomic arousal, depression, anxiety, and insomnia. Available evidence-based treatment approaches have been primarily directed at therapeutic users of benzodiazepines who do not meet criteria for a substance use disorder, with a general consensus that the gradual taper of benzodiazepines over a period of several months is the optimal approach. However, patients with benzodiazepine dependence are typically referred for inpatient detoxification treatment, which rapidly tapers patients off benzodiazepines. Protracted withdrawal symptoms frequently persist after discharge, predisposing patients to relapse. More effective pharmacotherapeutic strategies are needed for the treatment of benzodiazepine dependence in the outpatient setting.
Who is eligible to participate?
Inclusion Criteria: 1. Meets DSM-IV-TR criteria for BZD dependence 2. Using BZDs a minimum of 5 days per week over the past 28 days 3. Between the ages of 18 and 60 4. Able to provide informed consent Exclusion Criteria: 1. Any current DSM-IV-TR Axis I psychiatric disorder, other than BZD dependence, that might require intervention over the course of the study, including schizophrenia, bipolar disorder, major depressive disorder or panic disorder. 2. Receiving psychotropic medication other than BZDs 3. Evidence of physiological BZD withdrawal (pulse > 100; blood pressure > 140/90) 4. History of BZD withdrawal seizures or withdrawal delirium 5. History of allergic reaction to GBP 6. Pregnancy, lactation, or failure in female patients to use adequate contraceptive methods 7. Unstable physical disorders which might make participation hazardous medical history 8. Subjects who have a current DSM-IV-TR diagnosis of other substance dependence, with the exception of nicotine and caffeine history; dependence
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
GabapentinAll study medication will be over-capsulated with riboflavin to assess compliance using quantitative fluoroscopy. All participants will take three capsules three times per day throughout the study period. During week 1, GBP will be titrated over a five-day period to the dose target (GBP 1200 mg three times daily) or the maximum tolerated dose. Medication dosing will continue at GBP 1200 mg three times daily or placebo through the end of the study period (week 12). Dose reductions will be made for tolerability if necessary.
PlaceboCapsules filled with riboflavin.
Start Date: July 2013
Completed Date: December 2015
Phase: Phase 2
Primary Outcome: Abstinence from Benzodiazepine use
Study sponsors, principal investigator, and references
Principal Investigator: John J. Mariani, MD
Lead Sponsor: New York State Psychiatric Institute