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: July 31, 2014
Last verified: November 2013

December 5, 2005
July 31, 2014
May 2006
July 2013   (final data collection date for primary outcome measure)
  • Substance use severity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • PTSD symptom severity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Substance use severity
  • PTSD symptom severity
  • Global psychiatric severity
  • Retention rates in alcohol treatment
Complete list of historical versions of study NCT00262223 on ClinicalTrials.gov Archive Site
  • Alcohol subtypes based on pre-morbid risk factors [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Trajectory and trends of changes in substance use and PTSD symptoms [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Retention rates in alcohol treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Global psychiatric severity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Alcohol subtypes based on pre-morbid risk factors
  • Trajectory and trends of changes in substance use and PTSD symptoms
Not Provided
Not Provided
 
Combined Treatment for Alcohol-Dependent Individuals With PTSD
Combined Treatment for Alcohol-Dependent Individuals With PTSD

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
  • Stress Disorders, Post-Traumatic
  • Alcohol Abuse
  • Substance-Related Disorders
  • Behavioral: Seeking Safety
    Seeking Safety cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders
  • Drug: Sertraline
    An anti-depressant medication, selective serotonin reuptake inhibitor (SSRI) type
    Other Name: Zoloft
  • Active Comparator: 1) Seeking Safety + Sertraline
    Seeking Safety + Sertraline
    Interventions:
    • Behavioral: Seeking Safety
    • Drug: Sertraline
  • Placebo Comparator: 2) Seeking Safety + Placebo
    Seeking Safety + Placebo;
    Interventions:
    • Behavioral: Seeking Safety
    • Drug: Sertraline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
77
July 2013
July 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Males and females who are a minimum of 18 years and maximum of 65 years.
  2. Participants meet Diagnostic and Statistical Manual Diploma in Social Medicine IV (DSM-IV) criteria for current alcohol misuse, abuse or dependence.
  3. 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.
  4. 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.
  5. Participants demonstrate no gross organic mental syndrome.
  6. Participants are capable of giving informed consent and capable of complying with study procedures.
  7. Participants speak English.

Exclusion Criteria:

  1. Individuals who are at significant risk for suicide based on their current mental state or history.
  2. 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.
  3. Participants who are currently severely depressed.
  4. Participants with a history of psychosis or mania.
  5. Participants with organic mental syndrome.
  6. Participants physiologically dependent on any substance other than alcohol (excluding nicotine or caffeine or medically stable and managed methadone).
  7. Participants with comorbid substance abuse disorder who require detoxification treatment.
  8. 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.
  9. Participants with a known history of seizures (not related to alcohol withdrawal).
  10. Participants with moderate to severe alcohol withdrawal that would require pharmacological intervention.
  11. 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.
  12. A history of an allergic reaction to sertraline.
  13. 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.
  14. Participants refusing to be audio or videotaped.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00262223
#6266R-NIAAAHIE014341, R01AA014341-06
Yes
New York State Psychiatric Institute
New York State Psychiatric Institute
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Denise A. Hien, PhD City College of New York & New York State Psychiatric Institute/Columbia University
New York State Psychiatric Institute
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP