Clinical trial NCT02667119: Integrated Treatment for Posttraumatic Stress Disorder and Substance Abuse in Young Adults
Official title: Treating Co-Occurring PTSD and Substance Abuse in High-Risk Transition Age Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorder
Posttraumatic Stress Disorder
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2016-01-28
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Change in Severity of Posttraumatic Stress Disorder Symptoms as Measured by the National Stressful Events PTSD Scale
timeFrame: Baseline and 3-months post-baseline
measure: Change in Severity of Posttraumatic Stress Disorder Symptoms as Measured by the National Stressful Events PTSD Scale
timeFrame: Baseline and 6-month post-baseline
measure: Longest Duration of Abstinence From Illicit Drugs (Physiological Measure - Urine Drug Screens)
timeFrame: 10 week treatment period
Secondary outcomes:
measure: Change in Severity of Depression Symptoms as Measured by the Center for Epidemiological Studies-Depressed Mood Scale
timeFrame: Baseline and 3-month post-baseline
measure: Change in Severity of Depression Symptoms as Measured by the Center for Epidemiological Studies-Depressed Mood Scale
timeFrame: Baseline and 6-month post-baseline
measure: Change in Quality of Life as Measured by the Quality of Life Scale
timeFrame: Baseline and 3-month post-baseline
measure: Change in Quality of Life as Measured by the Quality of Life Scale
timeFrame: Baseline and 6-month post-baseline
Other outcomes:
Locations:
city: Farmington
country: United States
facility: UConn Health
state: Connecticut
city: Hartford
country: United States
facility: The Village for Families and Children - Adult Services
state: Connecticut
city: New Britain
country: United States
facility: Farrell Treatment Center
state: Connecticut
Study officials:
affiliation: UConn Health
name: Kristyn Zajac, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zajac K, Sheidow AJ, Davis M. Juvenile Justice, Mental Health, and the Transition to Adulthood: A Review of Service System Involvement and Unmet Needs in the U.S. Child Youth Serv Rev. 2015 Sep 1;56:139-148. doi: 10.1016/j.childyouth.2015.07.014.
citation: Zajac K, Randall J, Swenson CC. Multisystemic Therapy for Externalizing Youth. Child Adolesc Psychiatr Clin N Am. 2015 Jul;24(3):601-16. doi: 10.1016/j.chc.2015.02.007. Epub 2015 Mar 29.