A Phase 2 interventional study of gabapentin and Placebo in Benzodiazepine Dependence, sponsored by New York State Psychiatric Institute. Terminated at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-24.
Sponsored by New York State Psychiatric Institute · Phase 2, Interventional, and Treatment
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.
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.
New York State Psychiatric Institute is the lead sponsor of 425 studies on the registry; 26 are open to participants now.
Of its 50 completed or terminated interventional studies of FDA-regulated products, 45 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Capsules filled with riboflavin.
Drug: Placebo
Also known as: Neurontin
Abstinence From Benzodiazepine Use
Achievement of two weeks abstinence from benzodiazepine use at end of trial
Time frame: last two weeks of 12 week trial
| Milestone | Gabapentin | Placebo |
|---|---|---|
| Started | 1 | 1 |
| Completed | 1 | 1 |
| Not completed | 0 | 0 |
Achievement of two weeks abstinence from benzodiazepine use at end of trial
| Participants | Gabapentin | Placebo |
|---|---|---|
| Abstinence From Benzodiazepine Use | 0 | 0 |
Collected over 12 weeks of trial. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Gabapentin | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Placebo | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Event | Gabapentin | Placebo |
|---|---|---|
| anxietyGeneral disorders | 0/1 | 1/1 |
| appetite changeGastrointestinal disorders | 0/1 | 1/1 |
| nauseaGastrointestinal disorders | 0/1 | 1/1 |
| unsteady gaitMusculoskeletal and connective tissue disorders | 1/1 | 0/1 |
| chest tightnessGeneral disorders | 0/1 | 1/1 |
| confusionGeneral disorders | 1/1 | 0/1 |
| coordination issuesMusculoskeletal and connective tissue disorders | 1/1 | 0/1 |
| sensory overstimulationGeneral disorders | 0/1 | 1/1 |
| Age, Continuous(years) | Gabapentin | Placebo | Total |
|---|---|---|---|
| Mean | 59 ± 0 | 59 ± 0 | 59 ± 0 |
| Sex: Female, Male(Participants) | Gabapentin | Placebo | Total |
|---|---|---|---|
| Female | 0 | 1 | 1 |
| Male | 1 | 0 | 1 |
| Ethnicity (NIH/OMB)(Participants) | Gabapentin | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Gabapentin | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 1 | 0 | 1 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 |
This study is terminated, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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New York State Psychiatric Institute