Gabapentin Treatment of Benzodiazepine Dependence
Condition: Benzodiazepine Dependence
Intervention: gabapentin; Placebo
Intervention MeSH terms: Gabapentin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Benzodiazepines; clonazepam; alprazolam; Klonopin; Xanax; diazepam; Valium; lorazepam; Ativan

Summary:

      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.
    

Eligibility criteria:

        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