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Clinical Trials/NCT02667119
NCT02667119CompletedNot Applicable

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

UConn Health6 sites in 1 country27 target enrollmentStarted: April 1, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
27
Locations
6
Primary Endpoint
Change in Severity of Posttraumatic Stress Disorder Symptoms as Measured by the National Stressful Events PTSD Scale

Study 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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 25 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Investigators

Sponsor
UConn Health
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kristyn Zajac

Associate Professor

UConn Health

Study Sites (6)

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