Substance Use DisorderNCT02667119

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

A study testing Prolonged Exposure with Contingency Management in people with Substance Use Disorder and Posttraumatic Stress Disorder, run by UConn Health at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 25 years
Conditions the study is for: Substance Use Disorder, Posttraumatic Stress Disorder
What is being tested?: Prolonged Exposure with Contingency Management
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 3 sitesUnited States
Study dates: Apr 2016to 16 Jun 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 25 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

UConn Health
Farmington, Connecticut, 06030
The Village for Families and Children - Adult Services
Hartford, Connecticut, 06105
Farrell Treatment Center
New Britain, Connecticut, 06050

Other trials in United States

About this study

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

Conditions: Substance Use Disorder, Posttraumatic Stress Disorder
Being tested: Prolonged Exposure with Contingency Management, Standard Care
Medical subject headings: Substance-Related Disorders, Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Prolonged Exposure with Contingency ManagementBehavioural
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 CareBehavioural
Standard care will consist of treatment as usual in a community-based substance use treatment center.

Study groups in NCT02667119
Study group	Role	What they receive
Prolonged Exposure + Contingency Management	Experimental	Standard services plus Prolonged Exposure and Contingency Management Receives: Behavioral: Prolonged Exposure with Contingency Management; Behavioral: Standard Care
Standard Care	Active comparator	Standard substance abuse treatment services Receives: Behavioral: Standard Care

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: 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.
Measured: 10 week treatment period

Secondary outcomes (4)

Change in Severity of Depression Symptoms as Measured by the Center for Epidemiological Studies-Depressed Mood Scale
Center for Epidemiological Studies-Depressed Mood. Minimum value = 0. Maximum value = 60. Higher scores mean worse outcomes (more severe symptoms).
Measured: Baseline and 3-month post-baseline
Change in Severity of Depression Symptoms as Measured by the Center for Epidemiological Studies-Depressed Mood Scale
Center for Epidemiological Studies-Depressed Mood. Minimum value = 0. Maximum value = 60. Higher scores mean worse outcomes (more severe symptoms).
Measured: Baseline and 6-month post-baseline
Change in Quality of Life as Measured by the Quality of Life Scale
Quality of Life Scale. Minimum value = -6. Maximum value = +6. Score is an item mean. Higher scores mean better outcomes.
Measured: Baseline and 3-month post-baseline
Change in Quality of Life as Measured by the Quality of Life Scale
Quality of Life Scale. Minimum value = -6. Maximum value = +6. Score is an item mean. Higher scores mean better outcomes.
Measured: Baseline and 6-month post-baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 201616 Jun 2021

First posted28 Jan 2016 (estimated)
Study startApr 2016
Primary completion16 Jun 2021
Study completion16 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Substance Use DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02667119
Sponsor's protocol ID: 16-101-2
Other IDs: K23DA034879
Status last verified: Aug 2022
First submitted: 19 Jan 2016
Last updated: 22 Sep 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided

Publications

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.
PubMed 26273119
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.
PubMed 26092742

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treating Co-Occurring PTSD and Substance Abuse in High-Risk Transition Age Youth
ClinicalTrials.gov ID: NCT02667119
Acronym / sponsor ID: 16-101-2
Conditions: Substance Use Disorder, Posttraumatic Stress Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: UConn HealthUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: Apr 2016
Primary completion: 16 Jun 2021 (actual)
Study completion: 16 Jun 2021 (actual)
First posted: 28 Jan 2016 (estimated)
Results: Posted 22 Sep 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Prolonged Exposure + Contingency Management	Experimental	Behavioral: Prolonged Exposure with Contingency Management, Behavioral: Standard CareStandard services plus Prolonged Exposure and Contingency Management
Standard Care	Active comparator	Behavioral: Standard CareStandard substance abuse treatment services

Who may qualify

Ages: 18 to 25 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Prolonged Exposure with Contingency ManagementProlonged 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.	Behavioural	Prolonged Exposure + Contingency Management
Standard CareStandard care will consist of treatment as usual in a community-based substance use treatment center.	Behavioural	Prolonged Exposure + Contingency Management, Standard Care

Primary outcome

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).
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.

4 secondary outcomes

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
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
Change in Quality of Life as Measured by the Quality of Life Scale
Time frame: Baseline and 3-month post-baseline
Change in Quality of Life as Measured by the Quality of Life Scale
Time frame: Baseline and 6-month post-baseline

Results and safety

Results posted to the registry on 22 Sep 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Prolonged Exposure + Contingency Management	14	11
Standard Care	13	13

Primary outcome: 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. Mean (Standard Deviation). Unit: score on a scale

Measure	Prolonged Exposure + Contingency Management n = 12	Standard Care n = 12
Value	1.92 (.92)	2.61 (1.15)

Prolonged Exposure + Contingency Management vs Standard Care: F: 4.75, p = .041, ANCOVA

Population analysed: Two participants from the Prolonged Exposure + Contingency Management group and one participant from the Standard Care group did not complete assessments at 3 months post-baseline.

Primary outcome: 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. Mean (Standard Deviation). Unit: score on a scale

Measure	Prolonged Exposure + Contingency Management n = 11	Standard Care n = 13
Value	1.64 (.65)	2.29 (.93)

Prolonged Exposure + Contingency Management vs Standard Care: F: 6.89, p = .016, ANCOVA

Population analysed: Three participants from the Prolonged Exposure + Contingency Management group did not complete assessments at 6 months post-baseline.

Primary outcome: Longest Duration of Abstinence From Illicit Drugs (Physiological Measure - Urine Drug Screens)

Time frame: 10 week treatment period. Mean (Standard Deviation). Unit: weeks

Measure	Prolonged Exposure + Contingency Management n = 14	Standard Care n = 13
Value	4.29 (3.73)	1.77 (2.05)

Prolonged Exposure + Contingency Management vs Standard Care: t: -2.19, p = .04, t-test, 2 sided

Population analysed: Full sample was included

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Prolonged Exposure + Contingency Management	1 of 14 (7.1%)	4 of 14 (28.6%)	0 of 14
Standard Care	4 of 13 (30.8%)	6 of 13 (46.2%)	0 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 26273119Zajac 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.
Background: PubMed 26092742Zajac 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.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kristyn Zajac, PhD principal investigator

UConn Health

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Prolonged Exposure with Contingency Management in people with Substance Use Disorder and Posttraumatic Stress Disorder, run by UConn Health at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02667119, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2022.