Elizabeth C. Saunders

A randomized controlled trial of treatments for co-occurring substance use disorders and post-traumatic stress disorder

BACKGROUND AND AIMS Post-traumatic stress disorder (PTSD) is common among people with substance use disorders, and the comorbidity is associated with negative outcomes. We report on a randomized controlled trial comparing the effect of integrated cognitive-behavioral therapy (ICBT) plus standard care, individual addiction counseling plus standard care and standard care alone on substance use and PTSD symptoms. DESIGN Three-group, multi-site randomized controlled trial. SETTING Seven addiction treatment programs in Vermont and New Hampshire, USA. PARTICIPANTS/CASES Recruitment took place between December 2010 and January 2013. In this single-blind study, 221 participants were randomized to one of three conditions: ICBT plus standard care (SC) (n = 73), individual addiction counseling (IAC) plus SC (n = 75) or SC only (n = 73). One hundred and seventy-two patients were assessed at 6-month follow-up (58 ICBT; 61 IAC; 53 SC). Intervention and comparators: ICBT is a manual-guided therapy focused on PTSD and substance use symptom reduction with three main components: patient education, mindful relaxation and flexible thinking. IAC is a manual-guided therapy focused exclusively on substance use and recovery with modules organized in a stage-based approach: treatment initiation, early abstinence, maintaining abstinence and recovery. SC are intensive out-patient program services that include 9-12 hours of face-to-face contact per week over 2-4 days of group and individual therapies plus medication management. MEASUREMENTS Primary outcomes were PTSD severity and substance use severity at 6 months. Secondary outcomes were therapy retention. FINDINGS PTSD symptoms reduced in all conditions with no difference between them. In analyses of covariance, ICBT produced more favorable outcomes on toxicology than IAC or SC [comparison with IAC, parameter estimate: 1.10; confidence interval (CI) = 0.17-2.04; comparison with SC, parameter estimate: 1.13; CI = 0.18-2.08] and had a greater reduction in reported drug use than SC (parameter estimate: -9.92; CI = -18.14 to -1.70). ICBT patients had better therapy continuation versus IAC (P<0.001). There were no unexpected or study-related adverse events. CONCLUSIONS Integrated cognitive behavioral therapy may improve drug-related outcomes in post-traumatic stress disorder sufferers with substance use disorder more than drug-focused counseling, but probably not by reducing post-traumatic stress disorder symptoms to a greater extent.

Substance abuse treatment implementation research

Effective treatments exist for substance abuse. Yet they are not widely available (Ducharme et al, 2007; Garner et al, 2009; McLellan et al, 2003). Precise estimates cannot be discerned from existing data, but at best, 25% of community providers may offer evidence-based treatments such as addiction medications, psychosocial therapies or integrated services for persons with substance abuse and HIV or co-occurring psychiatric disorders. This problem is not unique to substance abuse treatment. In medicine, it has been suggested that it takes 17 years to translate 14% of the research to direct patient care (Balas & Boren, 2000; Green et al, 2009).

Using a Learning Collaborative Strategy With Office-based Practices to Increase Access and Improve Quality of Care for Patients With Opioid Use Disorders.

Objectives:Rapidly escalating rates of heroin and prescription opioid use have been widely observed in rural areas across the United States. Although US Food and Drug Administration-approved medications for opioid use disorders exist, they are not routinely accessible to patients. One medication, buprenorphine, can be prescribed by waivered physicians in office-based practice settings, but practice patterns vary widely. This study explored the use of a learning collaborative method to improve the provision of buprenorphine in the state of Vermont. Methods:We initiated a learning collaborative with 4 cohorts of physician practices (28 total practices). The learning collaborative consisted of a series of 4 face-to-face and 5 teleconference sessions over 9 months. Practices collected and reported on 8 quality-improvement data measures, which included the number of patients prescribed buprenorphine, and the percent of unstable patients seen weekly. Changes from baseline to 8 months were examined using a p-chart and logistic regression methodology. Results:Physician engagement in the learning collaborative was favorable across all 4 cohorts (85.7%). On 6 of the 7 quality-improvement measures, there were improvements from baseline to 8 months. On 4 measures, these improvements were statistically significant (P < 0.001). Importantly, practice variation decreased over time on all measures. The number of patients receiving medication increased only slightly (3.4%). Conclusions:Results support the effectiveness of a learning collaborative approach to engage physicians, modestly improve patient access, and significantly reduce practice variation. The strategy is potentially generalizable to other systems and regions struggling with this important public health problem.

The Prevalence of Posttraumatic Stress Disorder Symptoms among Addiction Treatment Patients with Cocaine Use Disorders.

Abstract Co-occurring cocaine use and posttraumatic stress disorders are prevalent and associated with negative treatment, health and societal consequences. This study examined the relationships among PTSD symptoms, gender, and cocaine use problems. Within a cross-sectional design, we gathered archival point prevalence data on new admissions (n = 573) to three addiction treatment agencies. Demographic, substance use, and PTSD symptom information were collected across the three agencies. Logistic regression analyses revealed that patients with cocaine use disorders had a two-fold increased odds for a probable PTSD diagnosis, compared to patients without a cocaine use disorder (OR = 2.19, 95% CI = 1.49–3.22, p < 0.001). Among females with cocaine use disorder, multinomial regression yielded a significant increase in the risk of moderate (RRR = 2.12, 95% CI = 1.10–4.10, p < 0.05) and severe (RRR = 2.87, 95% CI = 1.33–6.21, p < 0.01) PTSD symptoms. Males with cocaine use disorders had a two-fold increase in the risk of moderate PTSD symptoms (RRR = 2.13, 95% CI = 1.23–3.68, p < 0.01), but had no increased risk of developing severe PTSD symptoms (RRR = 1.93, 95% CI = 0.85–4.39, p = 0.117). Cocaine use appears to impact the risk of PTSD symptoms, especially in females. Future research should explore the generalizability of these findings to more racially and ethnically diverse samples, as well as among persons with this comorbidity who are not engaged in treatment services.

Use of Protamine for Anticoagulation During Carotid Endarterectomy: A Meta-analysis.

IMPORTANCE Protamine sulfate can be administered at the conclusion of carotid endarterectomy (CEA) to reverse the anticoagulant effects of heparin and to limit the risk for postoperative bleeding. Protamine use remains controversial owing to concern for increased thrombotic complications with its use. OBJECTIVE To review the evidence for and against protamine use, both in its association with increased thrombotic complications and with decreased bleeding. DATA SOURCES We searched Medline (1946-2014), EMBASE (1966-2014), Cochrane Library (1972-2014), clinical trial registries (World Health Organization International Clinical Trials Registry and clinicaltrials.gov), and abstracts from conferences of the Society of Vascular Surgery (2002-2014) and American Heart Association Scientific Sessions (1980-2014) in November 2014. No language restrictions were applied. STUDY SELECTION We included clinical trials and observational studies comparing reversal of heparin with protamine sulfate vs no reversal in patients undergoing carotid revascularization and reporting stroke during hospitalization. Of 360 records screened, 12 studies (3%) of CEA were eligible for data pooling. DATA EXTRACTION AND SYNTHESIS Two reviewers extracted data and assessed quality. Random-effects models were used to summarize relative risks (RRs). MAIN OUTCOME AND MEASURE Stroke after CEA. RESULTS We included 12 observational studies involving 10,621 patients in the meta-analysis. Event rates did not differ significantly between patients who received protamine vs those who did not for the following outcomes: stroke (RR, 0.84; 95% CI, 0.55-1.29; I(2) = 15%; 9 studies), myocardial infarction (RR, 0.89; 95% CI, 0.53-1.51; I(2) = 0%; 3 studies), or mortality (RR, 0.9, 95% CI, 0.62-1.29; I(2) = 0%; 7 studies). The use of protamine was associated with a significant decrease in major bleeding complications requiring reoperation (RR, 0.57; 95% CI, 0.39-0.84; I(2) = 32%; 10 studies). CONCLUSIONS AND RELEVANCE Based on available evidence, the use of protamine following CEA is associated with a reduction in bleeding complications, without increasing major thrombotic outcomes, including stroke, myocardial infarction, or death.

The impact of addiction medications on treatment outcomes for persons with co-occurring PTSD and opioid use disorders.

BACKGROUND AND OBJECTIVES Previous research has been inconclusive about whether adding psychosocial treatment to medication assisted treatment (MAT) improves outcomes for patients with co-occurring psychiatric and opioid use disorders. This study evaluated the impact of MAT and psychosocial therapies on treatment outcomes for patients with co-occurring opioid use disorders and PTSD. METHODS Patients meeting criteria for PTSD and substance use disorders were randomly assigned to one of three treatment conditions: Standard Care (SC) alone, Integrated Cognitive Behavioral Therapy (ICBT) plus SC, or Individual Addiction Counseling (IAC) plus SC. Substance use and psychiatric symptoms were assessed at baseline and 6 months. Only patients with opioid use disorders were included in the present analyses (n = 126). Two-way ANOVAS and logistic regression analyses were used to examine associations between treatment conditions and MAT, for substance use and psychiatric outcomes. RESULTS MAT patients receiving ICBT had significantly decreased odds of a positive urine drug screen, compared to non-MAT patients receiving SC alone (OR = .07, 95% CI = .01, .81, p = .03). For PTSD symptoms, a significant MAT by psychosocial treatment condition interaction demonstrated that MAT patients had comparable declines in PTSD symptoms regardless of psychosocial treatment type (F(2, 88) = 4.74, p = .011). Non-MAT patients in ICBT had significantly larger reductions in PTSD. CONCLUSIONS AND SCIENTIFIC SIGNIFICANCE For patients with co-occurring opioid use disorders and PTSD, MAT plus ICBT is associated with more significant improvement in substance use. For non-MAT patients, ICBT is most beneficial for PTSD symptoms.

Adherence and competence in two manual-guided therapies for co-occurring substance use and posttraumatic stress disorders: clinician factors and patient outcomes

Abstract Background: The challenges of implementing and sustaining evidence-based therapies into routine practice have been well-documented. Objectives: This study examines the relationship among clinician factors, quality of therapy delivery, and patient outcomes. Methods: Within a randomized controlled trial, 121 patients with current co-occurring substance use and posttraumatic stress disorders were allocated to receive either manualized Integrated Cognitive Behavioral Therapy (ICBT) or Individual Addiction Counseling (IAC). Twenty-two clinicians from seven addiction treatment programs were trained and supervised to deliver both therapies. Clinician characteristics were assessed at baseline; clinician adherence and competence were assessed over the course of delivering both therapies; and patient outcomes were measured at baseline and 6-month follow-up. Results: Although ICBT was delivered at acceptable levels, clinicians were significantly more adherent to IAC (p < 0.05). At session 1, clinical female gender (p < 0.05) and lower education level (p < 0.05) were predictive of increased clinician adherence and competence across both therapies. Adherence and competence at session 1 in either therapy were significantly predictive of positive patient outcomes. ICBT adherence (p < 0.05) and competence (p < 0.01) were predictive of PTSD symptom reduction, whereas IAC adherence (p < 0.01) and competence (p < 0.01) were associated with decreased drug problem severity. Conclusions: The differential impact of adherence and competence for both therapy types is consistent with their purported primary target: ICBT for PTSD and IAC for substance use. These findings also suggest the benefits of considering clinician factors when implementing manual-guided therapies. Future research should focus on diverse clinician samples, randomization of clinicians to therapy type, and prospective designs to evaluate models of supervision and quality monitoring.

Organizational capacity to address co-occurring substance use and psychiatric disorders: assessing variation by level of care.

Objectives: There is widespread recognition that services to persons with co-occurring substance use and psychiatric disorders should be accessible, yet most persons with these disorders do not receive care for both problems. Estimates of available services vary widely and have not examined potential variation by level of care. Methods: The present study samples 180 community addiction treatment programs and utilizes a standardized observational assessment of these programs using the dual diagnosis capability of addiction treatment (DDCAT) index. By level of care, the sample consisted of 53 outpatient programs, 50 intensive outpatient programs, and 77 residential programs. Results: Overall, approximately 81.1% of programs across levels of care offered addiction-only services, 18.3% dual diagnosis capable services, and less than 1% dual diagnosis enhanced services. Relative to residential and intensive outpatient programs, outpatient programs were more likely to have greater dual diagnosis capability (dual diagnosis capable services). Outpatient programs scored significantly higher on the DDCAT dimensions associated with program policies and continuity of care. Specific DDCAT benchmark items revealing detailed differences were found in these dimensions and specific assessment and treatment practices. Access to physician-prescriber or to psychotropic medications did not differ by level of care. Conclusions: The findings suggest that across levels of care, addiction-treatment systems and programs must continue to improve capacity for patients with co-occurring disorders. The application of a standardized, objective, and observational instrument may be useful to guide and measure the effectiveness of these efforts.

The influence of family and social problems on treatment outcomes of persons with co-occurring substance use disorders and PTSD.

Abstract Objective: Family and social problems may contribute to negative recovery outcomes in patients with co-occurring substance use and psychiatric disorders, yet few studies have empirically examined this relationship. This study investigates the impact of family and social problems on treatment outcomes among patients with co-occurring substance use and posttraumatic stress disorder (PTSD). Method: A secondary analysis was conducted using data collected from a randomized controlled trial of an integrated therapy for patients with co-occurring substance use and PTSD. Substance use, psychiatric symptoms and social problems were assessed. Longitudinal outcomes were analyzed using generalized estimating equations (GEEs) and multiple linear regression. Results: At baseline, increased family and social problems were associated with more severe substance use and psychiatric symptoms. Over time, all participants had comparable decreases in substance use and psychiatric problem severity. However, changes in family and social problem severity were predictive of PTSD symptom severity, alcohol use and psychiatric severity at follow-up. Conclusions: For patients with co-occurring substance use and PTSD, family and social problem severity is associated with substance use and psychiatric problem severity at baseline and over time. Targeted treatment for social and family problems may be optimal.

Is Integrated CBT Effective in Reducing PTSD Symptoms and Substance Use in Iraq and Afghanistan Veterans? Results from a Randomized Clinical Trial

This study is the first to examine integrated cognitive behavioral therapy (ICBT) in a sample of military veterans with co-occurring posttraumatic stress disorder (PTSD) and substance use disorders (SUD). Generalized linear mixed models were used to examine primary outcomes from a small, randomized clinical trial comparing ICBT plus treatment as usual (TAU) to TAU only in a sample (N = 44) of U.S. veterans who served in Iraq and/or Afghanistan. A significant reduction in PTSD and SUD symptoms over time was detected in both conditions. One significant time-by-condition interaction effect for re-experiencing symptoms was observed, with ICBT showing greater reductions from baseline to post-treatment. Overall, the efficacy of ICBT in this veteran sample was not as robust as outcomes with non-veteran patients. Challenges to engagement and retention in treatment and further intervention adaptations for veterans are discussed.