Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00183196
Status:
COMPLETED
Last Update Posted:
2018-06-07
First Post:
2005-09-13
Brief Title:
Effectiveness of Gabapentin When Used With Naltrexone to Treat Alcohol Dependence Compared to Placebo and Naltrexone Alone
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Gabapentin as an Adjunct to Naltrexone for Alcoholism
Status:
COMPLETED
Status Verified Date:
2018-05
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 purpose of this study is to determine whether after a period of abstinence adding 6 weeks of gabapentin a medication approved to treat seizures to a standard 16-week naltrexone an opiate blocking agent approved for the treatment of alcohol dependence treatment protocol is helpful in decreasing relapse to drinking compared to naltrexone alone or placebo All participants will receive alcohol counseling
Detailed Description:
Subjects will enter the trial after maintaining 4 days of abstinence During this period multiple assessments will be collected After entering the double blind treatment portion of the study they will be evaluated weekly for the first month then bi-weekly until week 12 and again at week 16 There will be two follow-up visits at weeks 28 and 40 Urinary riboflavin and pill counts will be utilized to determine compliance with the medication regime
Comparisons Naltrexone 50 mgday alone for 16-weeks naltrexone 50 mgday for 16-weeks plus gabapentin up to 1200 mgday in divided doses for the first 6 weeks or inactive placebos All subjects will receive up to 20 sessions of individual alcohol counseling
Comparisons Naltrexone 50 mgday alone for 16-weeks naltrexone 50 mgday for 16-weeks plus gabapentin up to 1200 mgday in divided doses for the first 6 weeks or inactive placebos All subjects will receive up to 20 sessions of individual alcohol counseling
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 |
|---|---|---|---|
| NIH RO1 AA09568 | US NIH GrantContract | None | httpsreporternihgovquickSearch5R01AA009568-14 |
| 5R01AA009568-14 | NIH | None | None |