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Combined Treatment for Alcohol-Dependent Individuals With PTSD

Primary Purpose

Stress Disorders, Post-Traumatic, Alcohol Abuse, Substance-Related Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Seeking Safety
Sertraline
Pill placebo
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post-Traumatic focused on measuring Co-morbid alcohol dependence and PTSD, Alcohol and other drug use disorders, Treatment outcome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Males and females who are a minimum of 18 years and maximum of 65 years. Participants meet Diagnostic and Statistical Manual Diploma in Social Medicine IV (DSM-IV) criteria for current alcohol misuse, abuse or dependence. Participants must have current alcohol use over past 90 days defined by more than or equal to 2 heavy drinking days or more than or equal to 14 drinks over 30 consecutive days or abstinence less than or equal to 21 consecutive days. Participants meet criteria for full or subthreshold PTSD. Subthreshold PTSD criteria differs from full PTSD in that the individual meets cluster C (numbing) OR cluster D (hyperarousal) whereas full PTSD requires that the individual meets both cluster C and D. Participants demonstrate no gross organic mental syndrome. Participants are capable of giving informed consent and capable of complying with study procedures. Participants speak English. Exclusion Criteria: Individuals who are at significant risk for suicide based on their current mental state or history. Participants with other current Axis I psychiatric disorders that, in the investigators' judgment, are unstable and would be disrupted by study medications. Current diagnosis of Bipolar I and psychotic disorders are exclusionary. Participants who are currently severely depressed. Participants with a history of psychosis or mania. Participants with organic mental syndrome. Participants physiologically dependent on any substance other than alcohol (excluding nicotine or caffeine or medically stable and managed methadone). Participants with comorbid substance abuse disorder who require detoxification treatment. Participants with unstable or significant physical disorders (e.g., uncontrolled hypertension, poorly-controlled diabetes, alanine aminotransferase/aspartate aminotransaminase (AST/ALT) three times the upper limit of normal) that would increase the risk of study participation. Participants with a known history of seizures (not related to alcohol withdrawal). Participants with moderate to severe alcohol withdrawal that would require pharmacological intervention. Participants currently taking prescribed psychotropic medication that is contraindicated for use with sertraline (e.g. antidepressant medications except for mirtazapine or trazodone when used for the treatment of insomnia ) and/or psychotropic medications where the participant has not achieved a stabilized regimen. Participants that are stable on medications that are not contraindicated with the use of sertraline (e.g., Methadone or Adderall) will not be excluded. A history of an allergic reaction to sertraline. Women who are currently pregnant or are trying to get pregnant or are nursing or are pre-menopausal and sexually active but not using effective birth control. Participants refusing to be audio or videotaped.

Sites / Locations

  • City College, City University of New York

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1) Seeking Safety + Sertraline

2) Seeking Safety + Placebo

Arm Description

Seeking Safety + Sertraline

Seeking Safety + Placebo;

Outcomes

Primary Outcome Measures

Heavy Drinking Days/Week
PTSD Symptom Severity / Clinician Administered PTSD Scale
Clinician Administered PTSD Scale (CAPS) is a 17-item, semi-structured interview of PTSD symptoms. Range of scores is 0-136. Five rationally derived severity score ranges for interpreting CAPS total score have been proposed: 0-19 = asymptomatic/few symptoms, 20-39 = mild PTSD/subthreshold, 40-59 = moderate PTSD/threshold, 60-79 = severe PTSD symptomatology, and >80 = extreme PTSD symptomology (Weathers et. al., 2001). A 15-point change in CAPS total severity score has been proposed as a marker of clinically significant change (Weathers et. al., 2001).

Secondary Outcome Measures

Full Information

First Posted
December 5, 2005
Last Updated
February 22, 2020
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00262223
Brief Title
Combined Treatment for Alcohol-Dependent Individuals With PTSD
Official Title
Combined Treatment for Alcohol-Dependent Individuals With PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This treatment intervention trial is designed for men and women with either alcohol misuse (e.g. 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 (e.g., hazardous or binge drinking) or alcohol use disorders (e.g. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic, Alcohol Abuse, Substance-Related Disorders
Keywords
Co-morbid alcohol dependence and PTSD, Alcohol and other drug use disorders, Treatment outcome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1) Seeking Safety + Sertraline
Arm Type
Active Comparator
Arm Description
Seeking Safety + Sertraline
Arm Title
2) Seeking Safety + Placebo
Arm Type
Placebo Comparator
Arm Description
Seeking Safety + Placebo;
Intervention Type
Behavioral
Intervention Name(s)
Seeking Safety
Intervention Description
Seeking Safety cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders
Intervention Type
Drug
Intervention Name(s)
Sertraline
Other Intervention Name(s)
Zoloft
Intervention Description
An anti-depressant medication, selective serotonin reuptake inhibitor (SSRI) type
Intervention Type
Drug
Intervention Name(s)
Pill placebo
Primary Outcome Measure Information:
Title
Heavy Drinking Days/Week
Time Frame
Baseline, End-of-treatment, 6-month follow-up and 12-month follow-up
Title
PTSD Symptom Severity / Clinician Administered PTSD Scale
Description
Clinician Administered PTSD Scale (CAPS) is a 17-item, semi-structured interview of PTSD symptoms. Range of scores is 0-136. Five rationally derived severity score ranges for interpreting CAPS total score have been proposed: 0-19 = asymptomatic/few symptoms, 20-39 = mild PTSD/subthreshold, 40-59 = moderate PTSD/threshold, 60-79 = severe PTSD symptomatology, and >80 = extreme PTSD symptomology (Weathers et. al., 2001). A 15-point change in CAPS total severity score has been proposed as a marker of clinically significant change (Weathers et. al., 2001).
Time Frame
Baseline, End-of-treatment, 6-month follow-up and 12-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and females who are a minimum of 18 years and maximum of 65 years. Participants meet Diagnostic and Statistical Manual Diploma in Social Medicine IV (DSM-IV) criteria for current alcohol misuse, abuse or dependence. Participants must have current alcohol use over past 90 days defined by more than or equal to 2 heavy drinking days or more than or equal to 14 drinks over 30 consecutive days or abstinence less than or equal to 21 consecutive days. Participants meet criteria for full or subthreshold PTSD. Subthreshold PTSD criteria differs from full PTSD in that the individual meets cluster C (numbing) OR cluster D (hyperarousal) whereas full PTSD requires that the individual meets both cluster C and D. Participants demonstrate no gross organic mental syndrome. Participants are capable of giving informed consent and capable of complying with study procedures. Participants speak English. Exclusion Criteria: Individuals who are at significant risk for suicide based on their current mental state or history. Participants with other current Axis I psychiatric disorders that, in the investigators' judgment, are unstable and would be disrupted by study medications. Current diagnosis of Bipolar I and psychotic disorders are exclusionary. Participants who are currently severely depressed. Participants with a history of psychosis or mania. Participants with organic mental syndrome. Participants physiologically dependent on any substance other than alcohol (excluding nicotine or caffeine or medically stable and managed methadone). Participants with comorbid substance abuse disorder who require detoxification treatment. Participants with unstable or significant physical disorders (e.g., uncontrolled hypertension, poorly-controlled diabetes, alanine aminotransferase/aspartate aminotransaminase (AST/ALT) three times the upper limit of normal) that would increase the risk of study participation. Participants with a known history of seizures (not related to alcohol withdrawal). Participants with moderate to severe alcohol withdrawal that would require pharmacological intervention. Participants currently taking prescribed psychotropic medication that is contraindicated for use with sertraline (e.g. antidepressant medications except for mirtazapine or trazodone when used for the treatment of insomnia ) and/or psychotropic medications where the participant has not achieved a stabilized regimen. Participants that are stable on medications that are not contraindicated with the use of sertraline (e.g., Methadone or Adderall) will not be excluded. A history of an allergic reaction to sertraline. Women who are currently pregnant or are trying to get pregnant or are nursing or are pre-menopausal and sexually active but not using effective birth control. Participants refusing to be audio or videotaped.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denise A. Hien, PhD
Organizational Affiliation
City College of New York & New York State Psychiatric Institute/Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
City College, City University of New York
City
New York
State/Province
New York
ZIP/Postal Code
10031
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25622199
Citation
Hien DA, Levin FR, Ruglass LM, Lopez-Castro T, Papini S, Hu MC, Cohen LR, Herron A. Combining seeking safety with sertraline for PTSD and alcohol use disorders: A randomized controlled trial. J Consult Clin Psychol. 2015 Apr;83(2):359-69. doi: 10.1037/a0038719. Epub 2015 Jan 26.
Results Reference
result
PubMed Identifier
26422415
Citation
Ruglass LM, Pedersen A, Cheref S, Hu MC, Hien DA. Racial differences in adherence and response to combined treatment for full and subthreshold post-traumatic stress disorder and alcohol use disorders: A secondary analysis. J Ethn Subst Abuse. 2016 Oct-Dec;15(4):434-448. doi: 10.1080/15332640.2015.1056927. Epub 2015 Sep 30.
Results Reference
result

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Combined Treatment for Alcohol-Dependent Individuals With PTSD

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