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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

Tracking Information
First Submitted Date  ICMJE June 29, 2013
First Posted Date  ICMJE July 9, 2013
Results First Submitted Date  ICMJE June 27, 2018
Results First Posted Date  ICMJE July 24, 2018
Last Update Posted Date April 24, 2019
Actual Study Start Date  ICMJE July 2013
Actual Primary Completion Date April 1, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: July 2, 2013)
Abstinence From Benzodiazepine Use [ Time Frame: 12 weeks ]
Achievement of two weeks abstinence from benzodiazepine use
Change History Complete list of historical versions of study NCT01893632 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gabapentin Treatment of Benzodiazepine Dependence
Official Title  ICMJE Gabapentin Treatment of Benzodiazepine Dependence
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Benzodiazepine Dependence
Intervention  ICMJE
  • Drug: gabapentin
    Other Name: Neurontin
  • Drug: Placebo
Study Arms  ICMJE
  • 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.
    Intervention: Drug: gabapentin
  • Placebo Comparator: Placebo
    Capsules filled with riboflavin.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 20, 2018)
2
Original Estimated Enrollment  ICMJE
 (submitted: July 2, 2013)
50
Actual Study Completion Date  ICMJE April 1, 2016
Actual Primary Completion Date April 1, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01893632
Other Study ID Numbers  ICMJE 6740
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party John Mariani MD, New York State Psychiatric Institute
Study Sponsor  ICMJE New York State Psychiatric Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John J. Mariani, MD New York State Psychiatric Institute
PRS Account New York State Psychiatric Institute
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP