Combined Treatment for Alcohol-Dependent Individuals With PTSD (NCT00262223) | Clinical Trial Compass
CompletedPhase 2
Combined Treatment for Alcohol-Dependent Individuals With PTSD
United States69 participantsStarted 2006-05
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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.
What they're measuring
1
Heavy Drinking Days/Week
Timeframe: Baseline, End-of-treatment, 6-month follow-up and 12-month follow-up
✕. 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.