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NCT01893632 · ClinicalTrials.gov registry record · Phase 2
Gabapentin Treatment of Benzodiazepine Dependence
A Phase 2 study, sponsored by New York State Psychiatric Institute.
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT01893632: Clinical Trial Phase 2 study, sponsored by New York State Psychiatric Institute.
NCT01893632 is a Phase 2 study that was terminated before completion, run by New York State Psychiatric Institute. The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01893632, a Phase 2 study, was terminated before completion, sponsored by New York State Psychiatric Institute.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study 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.
Primary Outcome
Achievement of two weeks abstinence from benzodiazepine use at end of trial
Interventions
- DRUG Placebo
- DRUG gabapentin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2013-07 |
| Est. Completion | 2016-04-01 |
| Phase | Phase 2 |
Why NCT01893632 stopped before completion
NCT01893632 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01893632 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01893632 about?
NCT01893632 is a clinical study titled "Gabapentin Treatment of Benzodiazepine Dependence". 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 ...
What is the current status of trial NCT01893632?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2013-07. Estimated completion is 2016-04-01.
What interventions are being tested in trial NCT01893632?
The interventions under investigation include: Placebo (DRUG), gabapentin (DRUG).
Who is sponsoring clinical trial NCT01893632?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01893632's enrollment target sits among peer trials
2 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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