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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02667119
Recruitment Status : Suspended (due to COVID-19)
First Posted : January 28, 2016
Last Update Posted : April 22, 2020
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Kristyn Zajac, UConn Health

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).

Condition or disease Intervention/treatment Phase
Substance Use Disorder Posttraumatic Stress Disorder Behavioral: Prolonged Exposure with Contingency Management Behavioral: Standard Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treating Co-Occurring PTSD and Substance Abuse in High-Risk Transition Age Youth
Study Start Date : April 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Prolonged Exposure + Contingency Management
Standard services plus Prolonged Exposure and Contingency Management
Behavioral: Prolonged Exposure with Contingency Management

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.


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

Active Comparator: Standard Care
Standard substance abuse treatment services
Behavioral: Standard Care
Standard care will consist of treatment as usual in a community-based substance use treatment center.




Primary Outcome Measures :
  1. Change in severity of posttraumatic stress disorder symptoms as measured by the National Stressful Events PTSD Scale [ Time Frame: Baseline and 3- and 6-months post-baseline, weekly for 10 weeks of treatment phase ]
  2. 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 of consecutive negative urine drug screens for illicit drugs during the 10 weeks of treatment.


Secondary Outcome Measures :
  1. Change in severity of depression symptoms as measured by the Center for Epidemiological Studies-Depressed Mood scale [ Time Frame: Baseline and 3- and 6-month post-baseline, weekly for 10 weeks of the treatment phase ]
  2. Change in criminal behavior as measured by the Self-Reported Offending Scale [ Time Frame: Baseline and 3- and 6-month post-baseline ]
  3. Change in Quality of Life as measured by the Quality of Life Scale [ Time Frame: Baseline and 3- and 6-month post-baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02667119


Locations
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United States, Connecticut
UConn Health
Farmington, Connecticut, United States, 06030
The Village for Families and Children - Adult Services
Hartford, Connecticut, United States, 06105
Farrell Treatment Center
New Britain, Connecticut, United States, 06050
Sponsors and Collaborators
UConn Health
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Kristyn Zajac, PhD UConn Health
Publications:
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Responsible Party: Kristyn Zajac, Assistant Professor, UConn Health
ClinicalTrials.gov Identifier: NCT02667119    
Other Study ID Numbers: 16-101-2
K23DA034879 ( U.S. NIH Grant/Contract )
First Posted: January 28, 2016    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Disease
Substance-Related Disorders
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Chemically-Induced Disorders