Status:
TERMINATED
Gabapentin Treatment of Benzodiazepine Dependence
Lead Sponsor:
New York State Psychiatric Institute
Conditions:
Benzodiazepine Dependence
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
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 sedativ...
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 p...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01893632
Start Date
July 1 2013
End Date
April 1 2016
Last Update
April 24 2019
Active Locations (1)
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1
John Mariani
New York, New York, United States, 10032