We compared the effectiveness of Seeking Safety (SS), an integrated cognitive behavioral treatment for substance use disorder (SUD) and post-traumatic stress disorder (PTSD), to an active comparison health education group (Women's Health Education [WHE]) within NIDA's Clinical Trials Network. We randomized 353 women to receive 12 sessions of SS (M = 6.2 sessions) or WHE (M = 6.0 sessions) with follow-up assessment at post-treatment and 3-, 6-, and 12-months post-treatment. Primary outcomes were the Clinician Administered PTSD Scale (CAPS) and PTSD Symptom Scale-Self Report (PSS-SR), and substance use (self-reported abstinence in the prior 7 days and days per week of any substance use). Intention-to-treat analysis showed large, clinically significant reductions in CAPS and PSS-SR symptoms (d = 1.94 and 1.12, respectively), but no reliable difference between conditions. Substance use outcomes were not significantly different over time between the two treatments and at follow-up showed no significant change from baseline, when 46% of participants were abstinent. Study results do not favor SS over WHE as an adjunct to SUD treatment for women with PTSD and reflect considerable opportunity to improve clinical outcomes in community-based treatments for these co-occurring conditions. NIH-PA Author ManuscriptNIH-PA Author Manuscript NIH-PA Author Manuscript in community based drug treatment, revealing a significant need for therapeutic approaches that can address adverse psychiatric consequences (e.g., Shore, Vollmer, & Tatum, 1989;Breslau, Davis, Andreski, & Peterson, 1991;Resnick, Kilpatrick, Dansky, Saunders, & Best, 1993). Yet, treatment research in this area remains limited.Quasi-experimental and small controlled studies (i.e., Finkelstein et al., 2004) suggest that a services model integrating cognitive behavioral treatment for trauma with substance abuse services can result in modest improvements in outcome (e.g., Amaro et al., 2007;Morrissey et al., 2005). For PTSD without co-occurring substance abuse, cognitive behavioral approaches have shown evidence of efficacy (e.g., Cloitre, Koenen, Cohen, & Han, 2002;Foa, Rothbaum, & Riggs, 1991). There has been concern, however, that discomfort aroused by focusing on the trauma could be harmful in substance dependent patients, who might escalate substance use or flee treatment. At the same time, the demand for specific interventions for patients with trauma and substance abuse has been mounting in community-based treatment systems (Cohen, Dickow, Horner, Zweben, & Balabis, 2003;Morrissey et al.).To address this need, Najavits (2002) developed Seeking Safety (SS), anintegrated cognitive behavioral treatment of PTSD and substance use disorder. Thus far, SS has been researched in various studies including a multisite controlled trial with homeless women veterans (Desai, Harpaz-Rotem, Najavits, & Rosenheck, 2008); two randomized control trials with low-income urban women and adolescent girls (Hien, Cohen, Miele, Litt & Capstick, 2004;Najavits, Gallop, & Weiss, 2006);...

Objective Drug and alcohol abuse constitutes a major public health problem. Computer-delivered interventions have potential to improve access to quality care. The objective of this study was to evaluate the effectiveness of the Therapeutic Education System, an internet-delivered behavioral intervention that includes motivational incentives, as a clinician-extender in the treatment of substance use disorders. Method Adult men and women (N=507) entering 10 outpatient addiction treatment programs were randomly assigned to 12-weeks of treatment-as-usual (n=252) or treatment-as-usual + Therapeutic Education System, whereby the intervention substituted for 2 hours of standard care per week (n=255). Therapeutic Education System consists of 62 computer-interactive modules covering skills for achieving and maintaining abstinence, plus prize-based motivational incentives contingent on abstinence and treatment adherence. Treatment-as-usual consisted of individual and group counseling at the participating programs. Primary outcomes were (1) abstinence from drugs and heavy drinking measured by twice weekly urine drug screens and self-report, and (2) time to drop-out from treatment. Results Compared to treatment-as-usual, those receiving Therapeutic Education System reduced dropout from treatment (Hazard Ratio=0.72 [95% CI, 0.57-0.92], P=.010), and increased abstinence (Odds Ratio=1.62 [95% CI: 1.12-2.35], P=.010), an effect that was more pronounced among patients with a positive urine drug and/or breath alcohol screen at the point of study entry (n=228) (Odds Ratio=2.18 [95% CI: 1.30-3.68], P=.003). Conclusion Internet-delivered interventions, such as Therapeutic Education System, have the potential to expand access and improve addiction treatment outcomes; additional research is needed to assess effectiveness in non-specialty clinical systems and to differentiate the effect of Community Reinforcement Approach and Contingency Management.

Objective-The purpose of the analysis was to examine the temporal course of improvement in Posttraumatic Stress Disorder (PTSD) and substance use disorder symptoms among women in outpatient substance abuse treatment.Method-Participants were 353 women randomized to 12 sessions of trauma-focused or health education group treatment. PTSD and substance use assessments were conducted during treatment and at 1-week, 3-, 6-, and 12-months post treatment. A continuous Markov model was fit on participants' four defined responder categories (non-responder, substance use responder, PTSD responder or global responder [improvement in both PTSD and substance use]) to investigate the temporal association between improvement in PTSD and substance use symptom severity during the study's treatment phase. A generalized linear model was applied to test this relationship over follow-up.Results-Non-responders, substance use responders and global responders tended to maintain original classification; PTSD responders were significantly more likely to transition to global responders over time, indicating maintained PTSD improvement was associated with subsequent substance use improvement. Trauma-focused treatment was significantly more effective in achieving substance use improvement compared to the health education group, but only among those who were heavy substance users at baseline and had achieved significant PTSD reductions.Conclusions-PTSD severity reductions were more likely to be associated with substance use improvement, with minimal evidence of substance use symptom reduction improving PTSD symptoms. Results support the self-medication model of coping with PTSD symptoms and an empirical basis for integrated interventions for improved substance use outcomes in patients with severe symptomatology.

Context Since drug-involved women are among the fastest growing groups with AIDS, sexual risk reduction intervention for them is a public health imperative. Objective Test effectiveness of HIV/STD safer sex skills building (SSB) groups for women in community drug treatment. Design Randomized trial of SSB versus standard HIV/STD Education (HE); assessments at baseline, 3- and 6- months Participants Women recruited from 12 methadone or psychosocial treatment programs in NIDA’s Clinical Trials Network. 515 women with ≥ one unprotected vaginal or anal sex occasion (USO) with a male partner in the past 6 months were randomized. Interventions In SSB, five 90-minute groups used problem-solving and skills rehearsal to increase HIV/STD risk awareness, condom use and partner negotiation skills. In HE, one 60-minute group covered HIV/STD disease, testing, treatment, and prevention information. Main Outcome Number of USOs at follow up. Results A significant difference in mean USOs was obtained between SSB and HE over time (F=67.2, p<.0001). At 3 months, significant decrements were observed in both conditions. At 6 months SSB maintained the decrease, HE returned to baseline (p<.0377). Women in SSB had 29% fewer USOs than those in HE. Conclusions Skills building interventions can produce ongoing sexual risk reduction in women in community drug treatment.

Clinical trials have been slow to incorporate e-technology (digital and electronic technology that utilizes mobile devices or the Internet) into the design and execution of studies. In the meantime, individuals and corporations are relying more on electronic platforms and most have incorporated such technology into their daily lives. This paper provides a general overview of the use of e-technologies in clinical trials research, specifically within the last decade, marked by rapid growth of mobile and Internet-based tools. Benefits of and challenges to the use of e-technologies in data collection, recruitment and retention, delivery of interventions, and dissemination are provided, as well as a description of the current status of regulatory oversight of e-technologies in clinical trials research. As an example of ways in which e-technologies can be used for intervention delivery, a summary of e-technologies for treatment of substance use disorders is presented. Using e-technologies to design and implement clinical trials has the potential to reach a wide audience, making trials more efficient while also reducing costs; however, researchers should be cautious when adopting these tools given the many challenges in using new technologies, as well as threats to participant privacy/confidentiality. Challenges of using e-technologies can be overcome with careful planning, useful partnerships, and forethought. The role of web- and smartphone-based applications is expanding, and the increasing use of those platforms by scientists and the public alike make them tools that cannot be ignored.