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Gabapentin Treatment of Benzodiazepine Dependence

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ClinicalTrials.gov Identifier: NCT01893632
Recruitment Status : Terminated (Insufficient recruitment, funding terminated from sponsor)
First Posted : July 9, 2013
Results First Posted : July 24, 2018
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
John Mariani MD, New York State Psychiatric Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Benzodiazepine Dependence Drug: gabapentin Drug: Placebo Phase 2

Detailed Description:

Gabapentin has proven to be a safe and well-tolerated medication with a low abuse liability, thereby making it ideal for use in the outpatient setting.

The proposed Exploratory Development research project is a double-blind randomized controlled clinical trial comparing the efficacy of gabapentin to placebo for the outpatient treatment of benzodiazepine dependence. The goal of this project is to study the effects of gabapentin on the participants' benzodiazepine use in a facilitated taper-to-abstinence model, where participants will be actively using benzodiazepines at study entry, gabapentin treatment will be introduced, and participants will be counseled to gradually discontinue benzodiazepine use over the study period while gabapentin treatment is maintained. A modified version of Medical Management will be used to facilitate compliance with study medication and other study procedures, and includes clinical instruction for gradually reducing benzodiazepine use 25% per week. Benzodiazepines are not prescribed in the proposed study; participants continue to obtain benzodiazepines from their own prescribed or nonprescribed sources.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Gabapentin Treatment of Benzodiazepine Dependence
Actual Study Start Date : July 2013
Actual Primary Completion Date : April 1, 2016
Actual Study Completion Date : April 1, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Gabapentin
All 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.
Drug: gabapentin
Other Name: Neurontin

Placebo Comparator: Placebo
Capsules filled with riboflavin.
Drug: Placebo



Primary Outcome Measures :
  1. Abstinence From Benzodiazepine Use [ Time Frame: last two weeks of 12 week trial ]
    Achievement of two weeks abstinence from benzodiazepine use at end of trial



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01893632


Locations
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United States, New York
John Mariani
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
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Principal Investigator: John J. Mariani, MD New York State Psychiatric Institute

Additional Information:
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Responsible Party: John Mariani MD, Assistant Professor of Clinical Psychiatry, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01893632     History of Changes
Other Study ID Numbers: 6740
First Posted: July 9, 2013    Key Record Dates
Results First Posted: July 24, 2018
Last Update Posted: April 24, 2019
Last Verified: April 2019

Keywords provided by John Mariani MD, New York State Psychiatric Institute:
Benzodiazepines
clonazepam
alprazolam
Klonopin
Xanax
diazepam
Valium
lorazepam
Ativan

Additional relevant MeSH terms:
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Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents