Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000448
Status:
COMPLETED
Last Update Posted:
2014-05-07
First Post:
1999-11-02
Brief Title:
Naltrexone Treatment for Alcoholic Women
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Naltrexone Consummatory Behaviors in Alcoholic Women
Status:
COMPLETED
Status Verified Date:
2014-05
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:
This study will assess naltrexones effectiveness in treating alcoholism in women and provide information on its potential value in treating eating disorders common among alcoholic women Alcoholic women with and without both eating disorders and depression will be randomly assigned to placebo or naltrexone treatment Each group will receive behavioral therapy for 12 weeks with followup 6 months after treatment
Detailed Description:
Background Despite important gender differences in drinking patterns physiological effects of alcohol and co-occurring psychiatric conditions relatively little is known about the efficacy of naltrexone for the treatment of alcohol dependence in women This study investigated the safety and efficacy of naltrexone in combination with Cognitive Behavioral Coping Skills Therapy CBCST in a sample of alcohol-dependent women some with comorbid eating pathology
Methods One hundred three women meeting DSM-IV criteria for alcohol dependence 29 with comorbid eating disturbances were randomized to receive either naltrexone or placebo for 12 weeks in addition to weekly group CBCST
Methods One hundred three women meeting DSM-IV criteria for alcohol dependence 29 with comorbid eating disturbances were randomized to receive either naltrexone or placebo for 12 weeks in addition to weekly group CBCST
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 |
|---|---|---|---|
| R01AA010225 | NIH | None | httpsreporternihgovquickSearchR01AA010225 |