Combined Treatment for Alcohol-Dependent Individuals With PTSD
Condition: Stress Disorders, Post-Traumatic; Alcohol Abuse; Substance-Related Disorders
MeSH terms: Alcoholism; Substance-Related Disorders; Stress Disorders, Post-Traumatic
Intervention: Seeking Safety; Sertraline; Pill placebo
Intervention description: Seeking Safety cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders; An anti-depressant medication, selective serotonin reuptake inhibitor (SSRI) type
Intervention MeSH terms: Sertraline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Co-morbid alcohol dependence and PTSD; Alcohol and other drug use disorders; Treatment outcome

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.
    

Eligibility 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.