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Combined Treatment for Alcohol-Dependent Individuals With PTSD

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ClinicalTrials.gov Identifier: NCT00262223
Recruitment Status : Completed
First Posted : December 6, 2005
Results First Posted : September 16, 2014
Last Update Posted : November 22, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Stress Disorders, Post-Traumatic Alcohol Abuse Substance-Related Disorders Behavioral: Seeking Safety Drug: Sertraline Drug: Pill placebo Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Combined Treatment for Alcohol-Dependent Individuals With PTSD
Study Start Date : May 2006
Primary Completion Date : July 2013
Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1) Seeking Safety + Sertraline
Seeking Safety + Sertraline
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
Placebo Comparator: 2) Seeking Safety + Placebo
Seeking Safety + Placebo;
Behavioral: Seeking Safety
Seeking Safety cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders
Drug: Pill placebo


Outcome Measures

Primary Outcome Measures :
  1. Heavy Drinking Days/Week [ Time Frame: Baseline, End-of-treatment, 6-month follow-up and 12-month follow-up ]
  2. PTSD Symptom Severity / Clinician Administered PTSD Scale [ Time Frame: Baseline, End-of-treatment, 6-month follow-up and 12-month follow-up ]
    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 :
  1. Alcohol Subtypes Based on Pre-morbid Risk Factors [ Time Frame: 1 year ]
  2. Trajectory and Trends of Changes in Substance Use and PTSD Symptoms [ Time Frame: 1 year ]
  3. Retention Rates in Alcohol Treatment [ Time Frame: 1 year ]
  4. Global Psychiatric Severity [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00262223


Locations
United States, New York
City College, City University of New York
New York, New York, United States, 10031
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Principal Investigator: Denise A. Hien, PhD City College of New York & New York State Psychiatric Institute/Columbia University
More Information

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00262223     History of Changes
Other Study ID Numbers: #6266R-NIAAAHIE014341
R01AA014341-06 ( U.S. NIH Grant/Contract )
First Posted: December 6, 2005    Key Record Dates
Results First Posted: September 16, 2014
Last Update Posted: November 22, 2017
Last Verified: October 2017

Keywords provided by New York State Psychiatric Institute:
Co-morbid alcohol dependence and PTSD
Alcohol and other drug use disorders
Treatment outcome

Additional relevant MeSH terms:
Disease
Alcoholism
Substance-Related Disorders
Stress Disorders, Post-Traumatic
Pathologic Processes
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Ethanol
Sertraline
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents