Gabapentin Treatment of Benzodiazepine Dependence

NCT01893632 | Terminated Phase 2 Results

• 1 other identifier: 6740
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Benzodiazepine Dependence

Keywords

Benzodiazepines; clonazepam; alprazolam; Klonopin; Xanax; diazepam; Valium; lorazepam; Ativan

Outcome Measures

Primary Outcomes (1)

• Abstinence From Benzodiazepine Use

  Achievement of two weeks abstinence from benzodiazepine use at end of trial

  last two weeks of 12 week trial

Study Arms (2)

Gabapentin

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Capsules filled with riboflavin.

Drug: Placebo

Interventions

gabapentin DRUG

Also known as: Neurontin

Gabapentin

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

John Mariani

New York, New York, 10032, United States

Location

Related Links

• Study Website

MeSH Terms

Interventions

Gabapentin

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

due to poor recruitment, enrollment was limited to two participants and trial was terminated.

Results Point of Contact

• Title: john mariani, md
• Organization: NYSPI

john.mariani@nyspi.columbia.edu

646-774-6140

Study Officials

• John J. Mariani, MD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Psychiatry

Study Record Dates

• First Submitted: June 29, 2013
• First Posted: July 9, 2013
• Study Start: July 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 24, 2019
• Results First Posted: July 24, 2018

Record last verified: 2019-04

Locations

US (1)