Status:
COMPLETED
Gabapentin Treatment of Benzodiazepine Abuse in Methadone Maintenance Patients
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Benzodiazepine Dependence
Opioid Dependence
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The aim of this project is to study the use of gabapentin in reducing benzodiazepine abuse in methadone maintenance patients. A second aim is to study the effects of gabapentin on craving, mood, anxie...
Detailed Description
The investigators will recruit individuals with current benzodiazepine abuse or dependence, as defined by the DSM-IV, who are receiving methadone maintenance treatment at the Bridge Plaza Treatment an...
Eligibility Criteria
Inclusion
- Men and women between the ages of 18-65 who meet DSM-IV criteria for benzodiazepine abuse or dependence, and opioid dependence, and are being treated for opioid dependence with methadone.
- Individuals seeking treatment for benzodiazepine abuse or dependence.
- Individuals capable of giving informed consent and capable of complying with study procedures.
- Individuals must have current benzodiazepine use.
- Individuals must report using, benzodiazepines an average \> 4 days per week over the past 28 days. The average amount of benzodiazepine used per using day must be \> lorazepam 4 mg/day or its equivalent
- (1 mg lorazepam = 0.25 mg clonazepam = 0.5 mg alprazolam = 5 mg diazepam = 10 mg chlordiazepoxide)
- Women of child-bearing age will be included provided that they are not pregnant, based on the results of a blood pregnancy test done at the time of screening and agree to use a method of contraception with proven efficacy and not to become pregnant during the study.
Exclusion
- Subjects with any current Axis I psychiatric disorder as defined by DSM-IV-TR supported by the SCID-I/P that in the investigator's judgment that are unstable or would be disrupted by study medication or by an effort to discontinue benzodiazepines. Disorders that are stable on psychotherapy or pharmacotherapy will not be exclusionary.
- Individuals with evidence of acute physiological benzodiazepine withdrawal.
- Individuals with a history of seizures during alcohol or sedative-hypnotic withdrawal.
- Individuals with a history of requiring pharmacologic detoxification from alcohol or sedative-hypnotic agents in the past year.
- Individuals meeting DSM IV criteria for current cocaine dependence as their primary substance use disorder diagnosis.
- Unstable physical disorders that might make participation hazardous such as uncontrolled hypertension and tachycardia (SBP \> 150 mm Hg, DBP \> 90 mm Hg, or a sitting quietly HR \> 100 bpm), acute hepatitis (patients with chronic mildly elevated transaminase levels \[2-3 x upper limit of normal\] are acceptable) or poorly controlled diabetes. Kidney disease or impaired kidney function that would interfere with the excretion of gabapentin is exclusionary.
- Patients currently taking prescribed psychotropic medications, other than methadone or medications prescribed for pain syndromes, that would be disrupted by study medication or by an effort to discontinue benzodiazepines. Anticonvulsants prescribed for pain syndromes are exclusionary.
- Patients with a known sensitivity to gabapentin.
- Individuals who have exhibited suicidal or homicidal behavior within the past two years or have current active suicidal ideation.
- Women who are pregnant or nursing.
- Individuals physiologically dependent on any other drugs (excluding nicotine, caffeine, methadone).
- Individuals currently prescribed gabapentin.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00420771
Start Date
January 1 2007
End Date
January 1 2011
Last Update
April 24 2019
Active Locations (1)
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1
Bridge Plaza Treatment and Rehabilitation Clinic
Long Island City, New York, United States, 11101