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Clinical Trials/NCT02667119
NCT02667119
Completed
Not Applicable

Treating Co-Occurring PTSD and Substance Abuse in High-Risk Transition Age Youth

UConn Health3 sites in 1 country27 target enrollmentApril 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Substance Use Disorder
Sponsor
UConn Health
Enrollment
27
Locations
3
Primary Endpoint
Change in Severity of Posttraumatic Stress Disorder Symptoms as Measured by the National Stressful Events PTSD Scale
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The purpose of the study is to determine the safety and efficacy of an integrated treatment for substance abuse and posttraumatic stress disorder for young adults. The integrated treatment includes two established psychosocial treatments for substance abuse (Contingency Management) and posttraumatic stress disorder (Prolonged Exposure therapy).

Registry
clinicaltrials.gov
Start Date
April 2016
End Date
June 16, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
UConn Health
Responsible Party
Principal Investigator
Principal Investigator

Kristyn Zajac

Associate Professor

UConn Health

Eligibility Criteria

Inclusion Criteria

  • 18-25 years old
  • meets diagnostic criteria for substance use disorder
  • meets diagnostic criteria for full or subthreshold posttraumatic stress disorder
  • currently able to provide a urine drug screen that is negative for cocaine, prescription opiates, and non-prescribed methadone or provided this type of screen in the past 60 days
  • speaks English

Exclusion Criteria

  • significant cognitive impairment or serious uncontrolled psychiatric problem (other than posttraumatic stress disorder)
  • in recovery from pathological gambling or current pathological gambling diagnosis
  • in a current domestic violence relationship

Outcomes

Primary Outcomes

Change in Severity of Posttraumatic Stress Disorder Symptoms as Measured by the National Stressful Events PTSD Scale

Time Frame: Baseline and 6-month post-baseline

National Stressful Events Posttraumatic Stress Disorder Short Scale. Outcome is presented as a mean item score. Minimum value = 1, Maximum value = 5. Higher scores mean worse outcomes (more severe symptoms).

Longest Duration of Abstinence From Illicit Drugs (Physiological Measure - Urine Drug Screens)

Time Frame: 10 week treatment period

Illicit drug use is assessed twice weekly during the 10 week treatment period. Longest duration of abstinence is calculated as the longest time period in weeks of consecutive negative urine drug screens for illicit drugs during the 10 weeks of treatment.

Secondary Outcomes

  • Change in Severity of Depression Symptoms as Measured by the Center for Epidemiological Studies-Depressed Mood Scale(Baseline and 6-month post-baseline)
  • Change in Quality of Life as Measured by the Quality of Life Scale(Baseline and 6-month post-baseline)

Study Sites (3)

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