Stress Disorders, Post-TraumaticNCT01365247
Concurrent Treatment for Substance Dependent Individuals With Post-Traumatic Stress Disorder (PTSD)
A study testing Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure and Relapse Prevention Treatment in people with Stress Disorders, Post-Traumatic and Substance-Related Disorders, run by The City College of New York at 1 site in United States.
Trial summary
This treatment intervention trial is designed for men and women with substance dependence and comorbid Post-Traumatic Stress Disorder (PTSD). Participants will be randomly assigned to one of three conditions (two behavioral treatments [Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Substance-Related Disorders
- What is being tested?
- Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure and Relapse Prevention Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women who are a minimum of 18 years and maximum of 65 years.
- Participants meet DSM-IV criteria for current or past substance dependence
- Participants must have used alcohol or other drugs within the past 3 months
- Participants must speak English
- Participants must meet DSM-IV criteria for current PTSD in response to on an interpersonal, civilian trauma
- Participants are capable of giving informed consent and capable of complying with study procedures.
- Participants demonstrate no gross organic mental syndrome
Who cannot join
- Participants who are currently suicidal or homicidal
- Participants who carry a diagnosis of BiPolar I or psychotic disorders are exclusionary.
- Participants receiving PTSD-specific treatment
- Participants on anxiolytic, antidepressant or mood stabilizing medications which have been initiated during the 8 weeks prior to study participation
- Participants refusing to be audio or video taped
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial of Concurrent Treatment for PTSD and Substance Dependence
This treatment intervention trial is designed for men and women with substance dependence and comorbid Post-Traumatic Stress Disorder (PTSD). Participants will be randomly assigned to one of three conditions (two behavioral treatments [Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure and Relapse Prevention Therapy] and an active monitoring control group) and will be evaluated at baseline and four follow-up points (post-treatment, 1-month, 2- month and 3-month post-treatment).
Read the detailed description
This study will enhance the knowledge and understanding of concurrently treating individuals with substance use disorders and PTSD in hopes of facilitating treatment retention and increasing the likelihood for more positive treatment outcomes. Following NIDA's stage model for behavior therapies development, this study will take the next step building upon promising findings from Stage IA work with an exposure-based therapy modified to use safely with substance dependent individuals.
This study is a randomized clinical trial to assess the relative efficacy of two active treatment conditions versus an active monitoring control group for substance dependent individuals who also meet criteria for current PTSD according to the diagnostic standards set by the DSM-IV. Eligible participants will be randomly assigned to either: (1) Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE); (2) Relapse Prevention Treatment (RPT) or an (3) Active Monitoring Control Group (AMCG). The study is a three armed randomized controlled trial with repeated outcome measures at post treatment and 1-,2-, and 3-months post-treatment follow-up points for participants in COPE and RPT.
- Being tested
- Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure, Relapse Prevention Treatment, Active Monitoring Control Group
- Keywords
- Co-morbid substance disorders and PTSD, Trauma, Alcohol and other drug use disorders, Treatment outcome, Post-Traumatic Stress Disorder (PTSD), Co-morbid Alcohol and other drug use disorders (AOD), Behavioral Treatment
- Medical subject headings
- Stress Disorders, Post-Traumatic, Substance-Related Disorders, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged ExposureBehavioural
A manualized, twelve-week intervention applying cognitive-behavioral strategies and prolonged exposure (PE) techniques to address substance use and trauma related issues.
Relapse Prevention TreatmentBehavioural
Relapse Prevention Treatment is a cognitive-behavioral skills training approach to initiating and maintaining substance use-related goals.
Active Monitoring Control GroupBehavioural
Participants meet with study staff on a weekly basis for the self-monitoring of PTSD and SUD symptoms. Visits consists of self-report assessments, urine toxicology, and a brief check-in with staff to confirm general health and safety.
| Study group | Role | What they receive |
|---|---|---|
| COPE | Experimental | Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure Receives: Behavioral: Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure |
| RPT | Active comparator | Relapse Prevention Therapy Receives: Behavioral: Relapse Prevention Treatment |
| Active Monitoring Control Group | Active comparator | Not described Receives: Behavioral: Active Monitoring Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Symptom Severity
Measured: Six months
Secondary outcomes (3)
Substance Use severity
Measured: Six months
Global psychiatric symptom severity
Measured: Six months
Treatment retention and compliance
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startSep 2008
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- The City College of New York
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of South Carolina, National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Denise Hien, The City College of New York
- Investigators
- Denise A. Hien, Ph.D., Principal investigator, City College of New York & New York State Psychiatric Institute/Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01365247
- Sponsor's protocol ID
- 1R01DA023187-01A1
- Other IDs
- 1R01DA023187-01A1
- Status last verified
- May 2015
- First submitted
- 1 Jun 2011
- Last updated
- 14 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Flanagan JC, Fischer MS, Badour CL, Ornan G, Killeen TK, Back SE. The Role of Relationship Adjustment in an Integrated Individual Treatment for PTSD and Substance Use Disorders Among Veterans: An Exploratory Study. J Dual Diagn. 2017 Jul-Sep;13(3):213-218. doi: 10.1080/15504263.2017.1312039. Epub 2017 May 25.
PubMed 28541802
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Concurrent Treatment for PTSD and Substance Dependence
- ClinicalTrials.gov ID
- NCT01365247
- Acronym / sponsor ID
- 1R01DA023187-01A1
- Keywords
- Co-morbid substance disorders and PTSD, Trauma, Alcohol and other drug use disorders, Treatment outcome, Post-Traumatic Stress Disorder (PTSD), Co-morbid Alcohol and other drug use disorders (AOD), Behavioral Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- The City College of New YorkUniversity, hospital or other
- Collaborators
- Medical University of South Carolina, National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2008
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 3 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This treatment intervention trial is designed for men and women with substance dependence and comorbid Post-Traumatic Stress Disorder (PTSD). Participants will be randomly assigned to one of three conditions (two behavioral treatments [Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure and Relapse Prevention Therapy] and an active monitoring control group) and will be evaluated at baseline and four follow-up points (post-treatment, 1-month, 2- month and 3-month post-treatment).
Detailed description
This study will enhance the knowledge and understanding of concurrently treating individuals with substance use disorders and PTSD in hopes of facilitating treatment retention and increasing the likelihood for more positive treatment outcomes. Following NIDA's stage model for behavior therapies development, this study will take the next step building upon promising findings from Stage IA work with an exposure-based therapy modified to use safely with substance dependent individuals.
This study is a randomized clinical trial to assess the relative efficacy of two active treatment conditions versus an active monitoring control group for substance dependent individuals who also meet criteria for current PTSD according to the diagnostic standards set by the DSM-IV. Eligible participants will be randomly assigned to either: (1) Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE); (2) Relapse Prevention Treatment (RPT) or an (3) Active Monitoring Control Group (AMCG). The study is a three armed randomized controlled trial with repeated outcome measures at post treatment and 1-,2-, and 3-months post-treatment follow-up points for participants in COPE and RPT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COPE | Experimental | Behavioral: Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged ExposureConcurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure |
| RPT | Active comparator | Behavioral: Relapse Prevention TreatmentRelapse Prevention Therapy |
| Active Monitoring Control Group | Active comparator | Behavioral: Active Monitoring Control Group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women who are a minimum of 18 years and maximum of 65 years.
- Participants meet DSM-IV criteria for current or past substance dependence
- Participants must have used alcohol or other drugs within the past 3 months
- Participants must speak English
- Participants must meet DSM-IV criteria for current PTSD in response to on an interpersonal, civilian trauma
Key exclusion criteria (5 listed)
- Participants who are currently suicidal or homicidal
- Participants who carry a diagnosis of BiPolar I or psychotic disorders are exclusionary.
- Participants receiving PTSD-specific treatment
- Participants on anxiolytic, antidepressant or mood stabilizing medications which have been initiated during the 8 weeks prior to study participation
- Participants refusing to be audio or video taped
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 |
|---|---|---|
| Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged ExposureA manualized, twelve-week intervention applying cognitive-behavioral strategies and prolonged exposure (PE) techniques to address substance use and trauma related issues. | Behavioural | COPE |
| Relapse Prevention TreatmentRelapse Prevention Treatment is a cognitive-behavioral skills training approach to initiating and maintaining substance use-related goals. | Behavioural | RPT |
| Active Monitoring Control GroupParticipants meet with study staff on a weekly basis for the self-monitoring of PTSD and SUD symptoms. Visits consists of self-report assessments, urine toxicology, and a brief check-in with staff to confirm general health and safety. | Behavioural | Active Monitoring Control Group |
Primary outcome
PTSD Symptom Severity
Time frame: Six months
3 secondary outcomes
Substance Use severity
Time frame: Six months
Global psychiatric symptom severity
Time frame: Six months
Treatment retention and compliance
Time frame: Six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2015.
- Derived from this study: PubMed 28541802Flanagan JC, Fischer MS, Badour CL, Ornan G, Killeen TK, Back SE. The Role of Relationship Adjustment in an Integrated Individual Treatment for PTSD and Substance Use Disorders Among Veterans: An Exploratory Study. J Dual Diagn. 2017 Jul-Sep;13(3):213-218. doi: 10.1080/15504263.2017.1312039. Epub 2017 May 25.
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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.
Denise A. Hien, Ph.D. principal investigator
City College of New York & New York State Psychiatric Institute/Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure and Relapse Prevention Treatment in people with Stress Disorders, Post-Traumatic and Substance-Related Disorders, run by The City College of New York at 1 site 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 7 inclusion and 5 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 14 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PTSD Symptom Severity (time frame: Six months). 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 NCT01365247, which also lists 1 linked publication.
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 14 May 2015.