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
|Condition or disease||Intervention/treatment||Phase|
|Benzodiazepine Dependence||Drug: gabapentin Drug: Placebo||Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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.
Other Name: Neurontin
Placebo Comparator: Placebo
Capsules filled with riboflavin.
- 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
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
|United States, New York|
|New York, New York, United States, 10032|
|Principal Investigator:||John J. Mariani, MD||New York State Psychiatric Institute|