NCT02667119

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 28, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2021

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

September 22, 2022

Completed
Last Updated

September 22, 2022

Status Verified

August 1, 2022

Enrollment Period

5.2 years

First QC Date

January 19, 2016

Results QC Date

June 16, 2022

Last Update Submit

August 29, 2022

Conditions

Substance Use DisorderPosttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (3)

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

    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).

    Baseline and 3-months post-baseline

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

    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).

    Baseline and 6-month post-baseline

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

    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.

    10 week treatment period

Secondary Outcomes (4)

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

    Baseline and 3-month post-baseline

  • 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 3-month post-baseline

  • Change in Quality of Life as Measured by the Quality of Life Scale

    Baseline and 6-month post-baseline

Study Arms (2)

Prolonged Exposure + Contingency Management

EXPERIMENTAL

Standard services plus Prolonged Exposure and Contingency Management

Behavioral: Prolonged Exposure with Contingency ManagementBehavioral: Standard Care

Standard Care

ACTIVE COMPARATOR

Standard substance abuse treatment services

Behavioral: Standard Care

Interventions

Prolonged Exposure with Contingency ManagementBEHAVIORAL

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.

Prolonged Exposure + Contingency Management
Standard CareBEHAVIORAL

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

Prolonged Exposure + Contingency ManagementStandard Care

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

UConn Health

Farmington, Connecticut, 06030, United States

Location

The Village for Families and Children - Adult Services

Hartford, Connecticut, 06105, United States

Location

Farrell Treatment Center

New Britain, Connecticut, 06050, United States

Location

Related Publications (2)

  • 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.

    PMID: 26273119BACKGROUND

  • 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.

    PMID: 26092742BACKGROUND

MeSH Terms

Conditions

Substance-Related DisordersStress Disorders, Post-Traumatic

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersStress Disorders, TraumaticTrauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Results Point of Contact

Title
Kristyn Zajac, PhD
Organization
UConn Health
zajac@uchc.edu
860-679-8572

Study Officials

  • Kristyn Zajac, PhD

    UConn Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 19, 2016

First Posted

January 28, 2016

Study Start

April 1, 2016

Primary Completion

June 16, 2021

Study Completion

June 16, 2021

Last Updated

September 22, 2022

Results First Posted

September 22, 2022

Record last verified: 2022-08

Locations

US(3)