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);...

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.

The effectiveness of a motivational and skills training HIV/AIDS group intervention designed for men in substance abuse treatment was evaluated. Men in methadone maintenance (n=288) or outpatient psychosocial treatment (n=302) completed assessments at baseline, 2 weeks, 3- and 6-months post intervention. Participants were randomly assigned to attend either “Real Men Are Safe” (REMAS; five sessions containing information, motivational exercises and skills training), or HIV education (HIV-Ed; one session containing HIV prevention information). REMAS participants engaged in significantly fewer unprotected vaginal and anal sexual intercourse occasions (USO) during the 90 days prior to the 3- and 6-month follow-ups than HIV-Ed participants. Completing REMAS resulted in an even stronger effect: completers reduced their number of USO by 21% from baseline to 6-month follow-up. In contrast, HIV-Ed completers increased the number of USO by 2%. A motivational and skills training HIV prevention intervention designed for men was associated with greater sexual risk reduction over standard HIV education. Substance abuse treatment programs can therefore help reduce sexual risk among their clientele by providing a more intensive intervention than what is traditionally provided.

Background Prescription opioid dependence is a growing problem, but little research exists on its treatment, including patient characteristics that predict treatment outcome. Methods A secondary analysis of data from a large multisite, randomized clinical trial, the National Drug Abuse Treatment Clinical Trials Network Prescription Opioid Addiction Treatment Study (POATS) was undertaken to examine baseline patient characteristics (N=360) associated with success during 12-week buprenorphine/naloxone treatment for prescription opioid dependence. Baseline predictor variables included self-reported demographic and opioid use history information, diagnoses assessed via the Composite International Diagnostic Interview, and historical opioid use and related information from the Pain And Opiate Analgesic Use History. Results In bivariate analyses, pre-treatment characteristics associated with successful opioid use outcome included older age, past-year or lifetime diagnosis of major depressive disorder, initially obtaining opioids with a medical prescription to relieve pain, having only used opioids by swallowing or sublingual administration, never having used heroin, using an opioid other than extended-release oxycodone most frequently, and no prior opioid dependence treatment. In multivariate analysis, age, lifetime major depressive disorder, having only used opioids by swallowing or sublingual administration, and receiving no prior opioid dependence treatment remained as significant predictors of successful outcome. Conclusions This is the first study to examine characteristics associated with treatment outcome in patients dependent exclusively on prescription opioids. Characteristics associated with successful outcome after 12 weeks of buprenorphine/naloxone treatment include some that have previously been found to predict heroin-dependent patients’ response to methadone treatment and some specific to prescription opioid-dependent patients receiving buprenorphine/naloxone.