Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00262223
Status:
COMPLETED
Last Update Posted:
2020-03-03
First Post:
2005-12-05
Brief Title:
Combined Treatment for Alcohol-Dependent Individuals With PTSD
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
Combined Treatment for Alcohol-Dependent Individuals With PTSD
Status:
COMPLETED
Status Verified Date:
2020-02
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 treatment intervention trial is designed for men and women with either alcohol misuse eg hazardous or binge drinking or alcohol use disorders alcohol abuse or dependence and comorbid PTSD Participants will be randomly assigned to one of two treatments a cognitive behavioral treatment intervention called Seeking Safety Medication Zoloft or Seeking Safety placebo and will be evaluated at baseline at completion of the treatment 12 sessions over 12 weeks and again at 6 months and 12 months post-treatment
Detailed Description:
The impetus for the current study is to contribute to the development of effective treatments targeted for men and women with either alcohol misuse eg hazardous or binge drinking or alcohol use disorders eg alcohol abuse or alcohol dependence and comorbid PTSD Research findings have shown that these individuals have poorer treatment outcomes and show more severe symptoms than treatment seeking alcohol-misusing or alcohol dependent participants without PTSD The aim of this study is to replicate and expand on 1 pilot studies demonstrating the effectiveness of a manualized cognitive-behavioral treatment specifically designed for individuals with comorbid substance use disorders and PTSD Seeking Safety 2 preliminary results on the effectiveness of the antidepressant sertraline Zoloft for a dually diagnosed population and 3 the examination of the effectiveness of these interventions over either treatment alone We are comparing Seeking Safety alone to Seeking Safety in combination with the antidepressant medication sertraline Zoloft in terms of their effectiveness in reducing alcohol use and PTSD symptoms Participants will be randomly assigned to one of two treatments Seeking Safety Med or Seeking Safety placebo and will be evaluated at baseline at completion of the treatment 12 sessions over 12 weeks and again at 6 months and 12 months post-treatment Secondary aims of the study include exploring potential differences between alcoholic subtypes on treatment outcomes impact of combined treatment on treatment participation and global psychiatric symptoms differences in the time course and order of changes in alcohol and drug use and PTSD symptoms by condition
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 |
|---|---|---|---|
| R01AA014341-06 | NIH | None | httpsreporternihgovquickSearchR01AA014341-06 |