Gabapentin Treatment of Benzodiazepine Dependence

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Benzodiazepine Dependence

In brief

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.

Key facts

Study ID

NCT01893632

Run by

New York State Psychiatric Institute

People needed

2

Starts

2013-07-01

Expected to finish

2016-04-01

Last updated by the study team

2019-04-24

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Meets DSM-IV-TR criteria for BZD dependence
• Using BZDs a minimum of 5 days per week over the past 28 days
• Between the ages of 18 and 60
• Able to provide informed consent

You may not qualify if…

• 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.
• Receiving psychotropic medication other than BZDs
• Evidence of physiological BZD withdrawal (pulse > 100; blood pressure > 140/90)
• History of BZD withdrawal seizures or withdrawal delirium
• History of allergic reaction to GBP
• Pregnancy, lactation, or failure in female patients to use adequate contraceptive methods
• Unstable physical disorders which might make participation hazardous medical history
• Subjects who have a current DSM-IV-TR diagnosis of other substance dependence, with the exception of nicotine and caffeine history; dependence

Where it is running

• John Mariani — New York, New York, United States

Full record on ClinicalTrials.gov

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