Trauma and Trauma-Focused Therapy in the University of Kentucky SMART Clinic

NCT04760418 | Completed

• 1 other identifier: 64485
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Opioid misuse is a national public health epidemic. More than 130 people in the United States die each day following an opioid overdose, and over 2 million people meet criteria for an opioid use disorder (OUD). Medication-assisted treatment (MAT), which involves use of medication (buprenorphine, methadone, naltrexone) in combination with behavioral therapy or counseling, is the most effective intervention for OUD. Yet, MAT remains less than optimally effective, particularly for patients with psychiatric comorbidity \[6\]. Novel approaches are needed to improve long-term outcomes for OUD patients. Psychological trauma and posttraumatic stress disorder (PTSD) are highly prevalent among individuals with OUD. Over 90% of adults with OUD report a lifetime history of trauma. Among OUD patients engaged in MAT, nearly 20% report experiencing at least one new traumatic event each month, and nearly a third meet criteria for a co-occurring diagnosis of posttraumatic stress disorder (PTSD). Several studies have linked new incidents of trauma as well as the presence of PTSD to poorer MAT engagement and poorer treatment outcomes, including treatment interruption and premature dropout. Preliminary evidence suggests that engaging in trauma-focused treatment for PTSD concurrent with MAT may result in better long-term adherence to medication for OUD. However, recent evidence finds that fewer than half of patients with PTSD in MAT receive any trauma-focused treatment, and even fewer receive evidence-based interventions. Trauma-focused treatments that concurrently address symptoms of PTSD and substance abuse using an integrated approach have been recommended over traditional substance abuse interventions for patients with this complex dual diagnosis presentation. Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE) is a 12-session evidence-based cognitive-behavioral therapy that integrates exposure therapy for PTSD with cognitive-behavioral skills for addressing problem substance use. COPE has demonstrated efficacy for reducing symptoms of PTSD and substance use disorder across multiple trials. Most samples have included patients with alcohol use disorder or mixed substance use disorder diagnoses. The proposed pilot study would collect preliminary feasibility data to support the first trial of COPE for patients with OUD (and other substance use disorders) who are currently engaged in MAT. As such, a primary aim of the current pilot is to obtain patient feedback regarding the acceptability and applicability of COPE for patients with PTSD receiving MAT treatment through the Supportive Medication Assisted Recovery Treatment (SMART) Program within the University of Kentucky (UK) Department of Psychiatry, an outpatient buprenorphine clinic. The investigators believe that it is critical to engage patients directly in the process of intervention development/refinement to determine how an existing evidence-based intervention like COPE might be modified to best fit the unique needs of patients receiving MAT.

Conditions

PTSD; Opioid-use Disorder; Substance Use Disorders

Outcome Measures

Primary Outcomes (2)

• PTSD Checklist for DSM-5 (PCL-5)

  Change in Posttraumatic Stress Disorder Symptom Severity

  Average symptom level and change slope from start to end of baseline (4 or 6 weeks) vs. from start to end of the 12-week treatment period

• Recovery Update Form

  Frequency of Substance Use

  Average symptom level and change slope from start to end of baseline (4 or 6 weeks) vs. from start to end of the 12-week treatment period

Study Arms (2)

4 week baseline

EXPERIMENTAL

Participants in this arm are randomized to a 4-week baseline period with repeated weekly assessment after the initial intake. This is followed by 12 sessions of weekly individual manualized Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE)

Behavioral: Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE)

6 week baseline

EXPERIMENTAL

Participants in this arm are randomized to a 6-week baseline period with repeated weekly assessment after the initial intake. This is followed by 12 sessions of weekly individual manualized Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE)

Behavioral: Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE)

Interventions

Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE) BEHAVIORAL

A 12-session integrated cognitive behavioral therapy for posttraumatic stress disorder and substance use

4 week baseline; 6 week baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently a patient in the University of Kentucky Department of Psychiatry Supportive Medication and Recovery Treatment (SMART) Program for at least 4 weeks
• Current diagnosis PTSD

You may not qualify if:

• History of schizophrenia or other psychotic disorder
• Current mania

Sponsors & Collaborators

• Christal L Badour: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

Related Publications (20)

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  BACKGROUND

• Hughes, A., et al., Prescription drug use and misuse in the United States: Results from the 2015 National Survey on Drug Use and Health. NSDUH Data Review, A1-A24. 2016.

  BACKGROUND

• Rudd RA, Seth P, David F, Scholl L. Increases in Drug and Opioid-Involved Overdose Deaths - United States, 2010-2015. MMWR Morb Mortal Wkly Rep. 2016 Dec 30;65(50-51):1445-1452. doi: 10.15585/mmwr.mm655051e1.

  PMID: 28033313 BACKGROUND

• SAMHSA, 2016 National Survey on Drug Use and Health. . 2016.

  BACKGROUND

• Oesterle TS, Thusius NJ, Rummans TA, Gold MS. Medication-Assisted Treatment for Opioid-Use Disorder. Mayo Clin Proc. 2019 Oct;94(10):2072-2086. doi: 10.1016/j.mayocp.2019.03.029. Epub 2019 Sep 19.

  PMID: 31543255 BACKGROUND

• National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Sciences Policy. Medication-Assisted Treatment for Opioid Use Disorder: Proceedings of a Workshop-in Brief. Washington (DC): National Academies Press (US); 2018 Nov 30. Available from http://www.ncbi.nlm.nih.gov/books/NBK534504/

  PMID: 30507113 BACKGROUND

• Lawson KM, Back SE, Hartwell KJ, Moran-Santa Maria M, Brady KT. A comparison of trauma profiles among individuals with prescription opioid, nicotine, or cocaine dependence. Am J Addict. 2013 Mar-Apr;22(2):127-31. doi: 10.1111/j.1521-0391.2013.00319.x.

  PMID: 23414497 BACKGROUND

• Peirce JM, Brooner RK, King VL, Kidorf MS. Effect of traumatic event reexposure and PTSD on substance use disorder treatment response. Drug Alcohol Depend. 2016 Jan 1;158:126-31. doi: 10.1016/j.drugalcdep.2015.11.006. Epub 2015 Nov 21.

  PMID: 26652898 BACKGROUND

• Ecker AH, Hundt N. Posttraumatic stress disorder in opioid agonist therapy: A review. Psychol Trauma. 2018 Nov;10(6):636-642. doi: 10.1037/tra0000312. Epub 2017 Jul 31.

  PMID: 28758767 BACKGROUND

• Hien DA, Nunes E, Levin FR, Fraser D. Posttraumatic stress disorder and short-term outcome in early methadone treatment. J Subst Abuse Treat. 2000 Jul;19(1):31-7. doi: 10.1016/s0740-5472(99)00088-4.

  PMID: 10867298 BACKGROUND

• Meshberg-Cohen S, Black AC, DeViva JC, Petrakis IL, Rosen MI. Trauma treatment for veterans in buprenorphine maintenance treatment for opioid use disorder. Addict Behav. 2019 Feb;89:29-34. doi: 10.1016/j.addbeh.2018.09.010. Epub 2018 Sep 12.

  PMID: 30243036 BACKGROUND

• Moreland, A., K. Crum, and C. Newman, Comorbid PTSD among women with opioid use disorder: Prevalence of symptoms and utilization in trauma-focused treatment, in International Society for Traumatic Stress Studies annual meeting. 2019: Boston, MA.

  BACKGROUND

• Roberts NP, Roberts PA, Jones N, Bisson JI. Psychological interventions for post-traumatic stress disorder and comorbid substance use disorder: A systematic review and meta-analysis. Clin Psychol Rev. 2015 Jun;38:25-38. doi: 10.1016/j.cpr.2015.02.007. Epub 2015 Mar 3.

  PMID: 25792193 BACKGROUND

• Simpson TL, Lehavot K, Petrakis IL. No Wrong Doors: Findings from a Critical Review of Behavioral Randomized Clinical Trials for Individuals with Co-Occurring Alcohol/Drug Problems and Posttraumatic Stress Disorder. Alcohol Clin Exp Res. 2017 Apr;41(4):681-702. doi: 10.1111/acer.13325. Epub 2017 Feb 10.

  PMID: 28055143 BACKGROUND

• Back SE, Killeen T, Badour CL, Flanagan JC, Allan NP, Ana ES, Lozano B, Korte KJ, Foa EB, Brady KT. Concurrent treatment of substance use disorders and PTSD using prolonged exposure: A randomized clinical trial in military veterans. Addict Behav. 2019 Mar;90:369-377. doi: 10.1016/j.addbeh.2018.11.032. Epub 2018 Nov 27.

  PMID: 30529244 BACKGROUND

• Brady KT, Dansky BS, Back SE, Foa EB, Carroll KM. Exposure therapy in the treatment of PTSD among cocaine-dependent individuals: preliminary findings. J Subst Abuse Treat. 2001 Jul;21(1):47-54. doi: 10.1016/s0740-5472(01)00182-9.

  PMID: 11516926 BACKGROUND

• Mills KL, Teesson M, Back SE, Brady KT, Baker AL, Hopwood S, Sannibale C, Barrett EL, Merz S, Rosenfeld J, Ewer PL. Integrated exposure-based therapy for co-occurring posttraumatic stress disorder and substance dependence: a randomized controlled trial. JAMA. 2012 Aug 15;308(7):690-9. doi: 10.1001/jama.2012.9071.

  PMID: 22893166 BACKGROUND

• Norman SB, Trim R, Haller M, Davis BC, Myers US, Colvonen PJ, Blanes E, Lyons R, Siegel EY, Angkaw AC, Norman GJ, Mayes T. Efficacy of Integrated Exposure Therapy vs Integrated Coping Skills Therapy for Comorbid Posttraumatic Stress Disorder and Alcohol Use Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2019 Aug 1;76(8):791-799. doi: 10.1001/jamapsychiatry.2019.0638.

  PMID: 31017639 BACKGROUND

• Persson A, Back SE, Killeen TK, Brady KT, Schwandt ML, Heilig M, Magnusson A. Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE): A Pilot Study in Alcohol-dependent Women. J Addict Med. 2017 Mar/Apr;11(2):119-125. doi: 10.1097/ADM.0000000000000286.

  PMID: 28079572 BACKGROUND

• Ruglass LM, Lopez-Castro T, Papini S, Killeen T, Back SE, Hien DA. Concurrent Treatment with Prolonged Exposure for Co-Occurring Full or Subthreshold Posttraumatic Stress Disorder and Substance Use Disorders: A Randomized Clinical Trial. Psychother Psychosom. 2017;86(3):150-161. doi: 10.1159/000462977. Epub 2017 May 11.

  PMID: 28490022 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Opioid-Related Disorders; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Narcotic-Related Disorders; Chemically-Induced Disorders

Study Officials

• Christal Badour, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Psychology

Model Details: Non-Concurrent Multiple Baseline Design

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: February 18, 2021
• Study Start: May 26, 2021
• Primary Completion: February 17, 2022
• Study Completion: February 17, 2022
• Last Updated: October 19, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be shared upon request from investigators beginning immediately after publication
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

US (1)