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Completed

NCT Number: NCT02667119

Integrated Treatment for Posttraumatic Stress Disorder and Substance Abuse in Young Adults

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).

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Key information

Conditions

Substance Use Disorder Chemically-Induced Disorders Mental Disorders Posttraumatic Stress Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Substance-Related Disorders Trauma and Stressor Related Disorders

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UConn Health, Farmington, Connecticut, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prolonged Exposure with Contingency Management

Behavioral

Prolonged Exposure therapy for posttraumatic stress disorder includes psychoeducation, breathing retraining, in vivo exposure, and imaginal exposure.

Contingency Management for substance abuse disorders: participants will have the chance to win prizes for each negative urine drug screen/breathalyzer provided.

Standard Care

Behavioral

Standard care will consist of treatment as usual in a community-based substance use treatment center.

Primary outcomes

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

    Time frame: Baseline and 3-months 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).

  2. 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).

  3. 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

  1. Change in Severity of Depression Symptoms as Measured by the Center for Epidemiological Studies-Depressed Mood Scale

    Time frame: Baseline and 3-month post-baseline

    Center for Epidemiological Studies-Depressed Mood. Minimum value = 0. Maximum value = 60. Higher scores mean worse outcomes (more severe symptoms).

  2. Change in Severity of Depression Symptoms as Measured by the Center for Epidemiological Studies-Depressed Mood Scale

    Time frame: Baseline and 6-month post-baseline

    Center for Epidemiological Studies-Depressed Mood. Minimum value = 0. Maximum value = 60. Higher scores mean worse outcomes (more severe symptoms).

  3. Change in Quality of Life as Measured by the Quality of Life Scale

    Time frame: Baseline and 3-month post-baseline

    Quality of Life Scale. Minimum value = -6. Maximum value = +6. Score is an item mean. Higher scores mean better outcomes.

  4. Change in Quality of Life as Measured by the Quality of Life Scale

    Time frame: Baseline and 6-month post-baseline

    Quality of Life Scale. Minimum value = -6. Maximum value = +6. Score is an item mean. Higher scores mean better outcomes.

Sponsors and collaborators

Lead sponsor

UConn Health

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Jan 28, 2016
Registry last updated
Sep 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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