Looking for benzo patients for a new study

 

 

Gabapentin Treatment of Benzodiazepine Dependence

 

 

This study is currently recruiting participants. (see Contacts and Locations)

 

Verified July 2013 by New York State Psychiatric Institute

 

Sponsor:

 

New York State Psychiatric Institute

 

Information provided by (Responsible Party):

 

New York State Psychiatric Institute

 

 

ClinicalTrials.gov Identifier:

 

NCT01893632

 

First received: June 29, 2013

 

Last updated: July 24, 2013

 

Last verified: July 2013

 

History of Changes

 

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  Purpose

 

 

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

 

Intervention

 

Phase

 

Benzodiazepine Dependence

Drug: gabapentin

Drug: Placebo

Phase 2

 

 

 

 

 

 

 

Study Type: Interventional 

Study Design: Allocation: Randomized

Endpoint Classification: Efficacy Study

Intervention Model: Parallel Assignment

Masking: Double Blind (Subject, Caregiver, Investigator)

Primary Purpose: Treatment

Official Title: Gabapentin Treatment of Benzodiazepine Dependence

 

 

Resource links provided by NLM:

 

 

 

Drug Information available for: Gabapentin Gabapentin enacarbil

U.S. FDA Resources

 

 

Further study details as provided by New York State Psychiatric Institute:

 

 

 

Primary Outcome Measures: •Abstinence from Benzodiazepine use [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Achievement of two weeks abstinence from benzodiazepine use

 

 

 

 

 

 

 

 

Estimated Enrollment: 50

Study Start Date: July 2013

Estimated Study Completion Date: December 2015

Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

 

 

 

Arms 

 

Assigned Interventions 

 

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 

 

  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.

 

  Eligibility

 

 

 

 

 

 

 

Ages Eligible for Study:    18 Years to 60 Years

Genders Eligible for Study:    Both

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

 

  Contacts and Locations

 

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

 

Please refer to this study by its ClinicalTrials.gov identifier: NCT01893632

 

 

Contacts

 

 

 

 

 

 

 

Contact: John J Mariani, MD 212-543-5987 mariani@pi.cpmc.columbia.edu 

 

 

Locations

 

 

 

 

 

United States, New York

New York State Psychiatric Institute Recruiting

New York, New York, United States, 10032 

Contact: John J Mariani, MD    212-543-5987    jm2330@columbia.edu   

Principal Investigator: John J Mariani, MD         

 

Sponsors and Collaborators

 

New York State Psychiatric Institute

 

Investigators

 

 

 

 

 

 

 

Principal Investigator: John J. Mariani, MD New York State Psychiatric Institute 

 

  More Information

 

Additional Information:

Study Website  This link exits the ClinicalTrials.gov site

 

No publications provided

 

 

 

 

 

 

Responsible Party: New York State Psychiatric Institute

ClinicalTrials.gov Identifier: NCT01893632    History of Changes 

Other Study ID Numbers: 6740

Study First Received: June 29, 2013

Last Updated: July 24, 2013

Health Authority: United States: Food and Drug Administration

 

 

Keywords provided by New York State Psychiatric Institute:

 

 

 

 

 

Benzodiazepines

clonazepam

alprazolam

Klonopin

Xanax

diazepam

Valium

lorazepam

Ativan

 

 

Additional relevant MeSH terms:

 

 

 

 

 

Gabapentin

Analgesics

Anti-Anxiety Agents

Anti-Dyskinesia Agents

Anticonvulsants

Antimanic Agents

Antiparkinson Agents

Calcium Channel Blockers

Cardiovascular Agents

Central Nervous System Agents

Central Nervous System Depressants

Excitatory Amino Acid Agents

Excitatory Amino Acid Antagonists

Membrane Transport Modulators

Molecular Mechanisms of Pharmacological Action

Neurotransmitter Agents

Peripheral Nervous System Agents

Pharmacologic Actions

Physiological Effects of Drugs

Psychotropic Drugs

Sensory System Agents

Therapeutic Uses

Tranquilizing Agents

 

 

ClinicalTrials.gov processed this record on June 11, 2015

 

 

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Not going to take a pill to fix what the first pill **** with---it's a hamster wheel.  I want my brain back and trust in my bodies resilience and innate intelligence.

 

Took neurontin already as part of the cocktail of my former life polydrugged. 

 

No thanks...and I think many of us here know how reliable these 'drug studies' really are.

 

 

 

 

edit: profanity

Benzogirl, good to see that some where for some reason some one might be finally be giving a shit, but i bet it`s funded bye big Pharma ! So not me Jack my luck i would get the placebo ~ CD

can do: I thought you like sugar...

Not going to take a pill to fix what the first pill fucked with---it's a hamster wheel.  I want my brain back and trust in my bodies resilience and innate intelligence.

 

Took neurontin already as part of the cocktail of my former life polydrugged. 

 

No thanks...and I think many of us here know how reliable these 'drug studies' really are.

 

I'd rather eat a dead mouse .....lab rat here has learned a lesson

for life...