Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00420771
Status:
COMPLETED
Last Update Posted:
2019-04-24
First Post:
2007-01-08
Brief Title:
Gabapentin Treatment of Benzodiazepine Abuse in Methadone Maintenance Patients
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
A Randomized Controlled Pilot Trial of Gabapentin for the Treatment of Benzodiazepine Abuse in Methadone Maintenance Patients
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 anxiety and sleep disturbance in methadone maintenance patients abusing benzodiazepines The proposed protocol is a randomized double-blind placebo-controlled pilot outpatient trial of gabapentin in the treatment of benzodiazepine abuse in methadone maintenance patients All subjects will receive weekly manual-guided psychotherapy directed at achieving abstinence and improving current functioning The primary outcome measure benzodiazepine use will be assessed weekly by a combination of self-report time line follow-back method and urine toxicology Associated psychological symptoms of craving mood anxiety and sleep disturbance will be assessed by a combination of clinician and self-rated instruments
The investigators hypothesize that individuals receiving methadone maintenance treatment who are abusing nonprescribed use benzodiazepines have difficulty in reducing or discontinuing benzodiazepine use because of the significant anxiety mood and sleep disturbance symptoms that accompany reduction in use Gabapentin an anticonvulsant which has anxiolytic and sedating properties may alleviate the symptoms associated with a reduction in benzodiazepine abuse and make the achievement of abstinence more likely when administered in the setting of an active psychotherapy condition
The investigators hypothesize that individuals receiving methadone maintenance treatment who are abusing nonprescribed use benzodiazepines have difficulty in reducing or discontinuing benzodiazepine use because of the significant anxiety mood and sleep disturbance symptoms that accompany reduction in use Gabapentin an anticonvulsant which has anxiolytic and sedating properties may alleviate the symptoms associated with a reduction in benzodiazepine abuse and make the achievement of abstinence more likely when administered in the setting of an active psychotherapy condition
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 and Rehabilitation Clinic The initial step in recruitment for all patients will be a referral from a clinic counselor
The investigators plan to enroll 86 participants into the study Both males and females will be recruited The distribution of benzodiazepine abuse in methadone maintenance populations with regard to race and gender is not well studiedThe investigators expect the gender and racial distribution of subjects to reflect the demographic nature of the Bridge Plaza Treatment and Rehabilitation Clinic which is approximately 33 Caucasian 33 African-American and 33 Hispanic and 40 female The investigators will make every effort to recruit minority patients in order to ensure the ability to generalize our findings to the overall treatment population
All patients will begin medication at the start of the study Subjects will take medication twice each day once in the morning and once in the evening All tablets placebo and study medication will be over-capsulated with riboflavin to measure compliance The placebo group will have a dosing schedule that is identical to the gabapentin group ie they will take the same number of pills each day Medication will be dispensed weekly in individual vials identified by patient with dosing instructions written on the outside of the vials Patients in the placebo group will not receive gabapentin at any time during the study Gabapentin will be administered in 400 mg tablets placebo tablets will appear identical to the gabapentin tablets Gradual increases in medication doses are used in order to minimize side effects and enhance compliance At the start of week 1 the group receiving gabapentin will be administered at 400 mg three-times a day This dose will be increased to 800 mg three-times a day at week 2 and increased to 1200 mg three-times a day at the start of week 3 The dose will continue at 1200 mg three-times a day for weeks 3 through 8 Dose reductions for tolerability will be made by the research psychiatrist in coordination with the research pharmacy All patients must take a minimum of gabapentinplacebo 400 mg BID to remain in the study
Both the active and placebo medication capsules will contain riboflavin which will allow the clinic to verify that the study medication is being taken correctly and absorbed by the body Urine samples obtained weekly will be examined under a UV lamp in order to observe any fluorescence signifying the consumption of the study capsules The patient will consume approximately 100 mg of riboflavin daily
The goal of compliance enhancement therapy is to achieve high quality supportive treatment as well as consistency between treatment groups Treatment will be delivered in 9 individual sessions over 9 weeks Sessions will last approximately 30 minutes and will be structured focused on setting abstinence from benzodiazepine use as a goal patient compliance and current functioning The therapist will promote a positive supportive therapeutic relationship with the treatment goal of encouraging abstinence from benzodiazepines and adherence to study visits and medication
The investigators plan to enroll 86 participants into the study Both males and females will be recruited The distribution of benzodiazepine abuse in methadone maintenance populations with regard to race and gender is not well studiedThe investigators expect the gender and racial distribution of subjects to reflect the demographic nature of the Bridge Plaza Treatment and Rehabilitation Clinic which is approximately 33 Caucasian 33 African-American and 33 Hispanic and 40 female The investigators will make every effort to recruit minority patients in order to ensure the ability to generalize our findings to the overall treatment population
All patients will begin medication at the start of the study Subjects will take medication twice each day once in the morning and once in the evening All tablets placebo and study medication will be over-capsulated with riboflavin to measure compliance The placebo group will have a dosing schedule that is identical to the gabapentin group ie they will take the same number of pills each day Medication will be dispensed weekly in individual vials identified by patient with dosing instructions written on the outside of the vials Patients in the placebo group will not receive gabapentin at any time during the study Gabapentin will be administered in 400 mg tablets placebo tablets will appear identical to the gabapentin tablets Gradual increases in medication doses are used in order to minimize side effects and enhance compliance At the start of week 1 the group receiving gabapentin will be administered at 400 mg three-times a day This dose will be increased to 800 mg three-times a day at week 2 and increased to 1200 mg three-times a day at the start of week 3 The dose will continue at 1200 mg three-times a day for weeks 3 through 8 Dose reductions for tolerability will be made by the research psychiatrist in coordination with the research pharmacy All patients must take a minimum of gabapentinplacebo 400 mg BID to remain in the study
Both the active and placebo medication capsules will contain riboflavin which will allow the clinic to verify that the study medication is being taken correctly and absorbed by the body Urine samples obtained weekly will be examined under a UV lamp in order to observe any fluorescence signifying the consumption of the study capsules The patient will consume approximately 100 mg of riboflavin daily
The goal of compliance enhancement therapy is to achieve high quality supportive treatment as well as consistency between treatment groups Treatment will be delivered in 9 individual sessions over 9 weeks Sessions will last approximately 30 minutes and will be structured focused on setting abstinence from benzodiazepine use as a goal patient compliance and current functioning The therapist will promote a positive supportive therapeutic relationship with the treatment goal of encouraging abstinence from benzodiazepines and adherence to study visits and medication
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K23DA021209 | NIH | None | httpsreporternihgovquickSearchK23DA021209 |