Combined Treatment for Alcohol-Dependent Individuals With PTSD

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00262223
First received: December 5, 2005
Last updated: September 3, 2014
Last verified: November 2013
Results First Received: August 14, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Treatment
Conditions: Stress Disorders, Post-Traumatic
Alcohol Abuse
Substance-Related Disorders
Interventions: Behavioral: Seeking Safety
Drug: Sertraline
Drug: Pill placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants in the metropolitan New York area were recruited through newspaper and radio advertisements, flyers, and referrals from outpatient mental health centers between April 2006 and March 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Individuals were screened through a brief telephone interview and then completed a baseline interview. After baseline assessment and medical clearance, eligible participants began a one-week, single-blind placebo lead-in phase. Those who completed the lead in phase were accepted into the study.

Reporting Groups
  Description
1) Seeking Safety + Sertraline

Seeking Safety + Sertraline

Seeking Safety: Seeking Safety cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders

Sertraline: An anti-depressant medication, selective serotonin reuptake inhibitor (SSRI) type

2) Seeking Safety + Placebo

Seeking Safety + Placebo;

Seeking Safety: Seeking Safety cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders

Sertraline: An anti-depressant medication, selective serotonin reuptake inhibitor (SSRI) type


Participant Flow for 4 periods

Period 1:   Treatment Phase
    1) Seeking Safety + Sertraline     2) Seeking Safety + Placebo  
STARTED     32     37  
COMPLETED     28     29  
NOT COMPLETED     4     8  
Withdrawal by Subject                 3                 6  
Adverse Event                 1                 2  

Period 2:   1-week Post-treatment Follow-up
    1) Seeking Safety + Sertraline     2) Seeking Safety + Placebo  
STARTED     28     29  
COMPLETED     24     25  
NOT COMPLETED     4     4  
Lost to Follow-up                 4                 4  

Period 3:   6-month Post-treatment Follow-up
    1) Seeking Safety + Sertraline     2) Seeking Safety + Placebo  
STARTED     28 [1]   29 [1]
COMPLETED     22     28  
NOT COMPLETED     6     1  
Lost to Follow-up                 6                 1  
[1] Subjects were included in subsequent follow-ups even if lost to contact during previous follow-up.

Period 4:   12-month Post-treatment Follow-up
    1) Seeking Safety + Sertraline     2) Seeking Safety + Placebo  
STARTED     28 [1]   29 [1]
COMPLETED     21     22  
NOT COMPLETED     7     7  
Lost to Follow-up                 7                 7  
[1] Subjects were included in subsequent follow-ups even if lost to contact during previous follow-up.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
1) Seeking Safety + Sertraline Seeking Safety, a cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders + Setraline, an anti-depressant medication, selective serotonin reuptake inhibitor (SSRI) type
2) Seeking Safety + Placebo Seeking Safety, a cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders + Pill placebo
Total Total of all reporting groups

Baseline Measures
    1) Seeking Safety + Sertraline     2) Seeking Safety + Placebo     Total  
Number of Participants  
[units: participants]
  32     37     69  
Age  
[units: years]
Mean ± Standard Deviation
  42.2  ± 9.8     42.5  ± 8.5     42.5  ± 9.0  
Gender  
[units: participants]
     
Female     26     30     56  
Male     6     7     13  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Heavy Drinking Days   [ Time Frame: Baseline, End-of-treatment, 6-month follow-up and 12-month follow-up ]

2.  Primary:   PTSD Symptom Severity / Clinician Administered PTSD Scale   [ Time Frame: Baseline, End-of-treatment, 6-month follow-up and 12-month follow-up ]

3.  Secondary:   Alcohol Subtypes Based on Pre-morbid Risk Factors   [ Time Frame: 1 year ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Trajectory and Trends of Changes in Substance Use and PTSD Symptoms   [ Time Frame: 1 year ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Retention Rates in Alcohol Treatment   [ Time Frame: 1 year ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Global Psychiatric Severity   [ Time Frame: 1 year ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Denise A. Hien, Ph.D.
Organization: The City College of New York
phone: (212) 650-5666
e-mail: dhien@ccny.cuny.edu


No publications provided


Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00262223     History of Changes
Other Study ID Numbers: #6266R-NIAAAHIE014341, R01AA014341-06
Study First Received: December 5, 2005
Results First Received: August 14, 2014
Last Updated: September 3, 2014
Health Authority: United States: Federal Government