Objective The current study marks the first randomized controlled trial to test the benefit of combining Seeking Safety (SS), a present-focused cognitive behavioral therapy for co-occurring posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD), with sertraline, a front-line medication for PTSD shown to also impact drinking outcomes. Method Sixty-nine participants (81% female; 59% African American) with primarily childhood sexual (46%) and physical (39%) trauma exposure, and drug dependence in addition to AUD were randomized to receive a partial-dose (12 sessions) of SS with either sertraline (n = 32; M = 7 sessions) or placebo (n = 37; M = 6 sessions). Assessments conducted at baseline, end-of-treatment, 6- and 12-months posttreatment measured PTSD and AUD symptom severity. Results Both groups demonstrated significant improvement in PTSD symptoms. The SS plus sertraline group exhibited a significantly greater reduction in PTSD symptoms than the SS plus placebo group at end-of-treatment (M difference = −16.15, p = .04, d = 0.83), which was sustained at 6- and 12-month follow-up (M difference = −13.81, p = .04, d = 0.71, and M difference = −12.72, p = .05, d = 0.65, respectively). Both SS groups improved significantly on AUD severity at all posttreatment time points with no significant differences between SS plus sertraline and SS plus placebo. Conclusion Results support the combining of a cognitive behavioral therapy and sertraline for PTSD/AUD. Clinically significant reductions in both PTSD and AUD severity were achieved and sustained through 12-months follow-up, Moreover, greater mean improvement in PTSD symptoms was observed across all follow-up assessments in the SS plus sertraline group.

Background Noncompliance with medications may have major impacts on outcomes measured in research, potentially distorting the validity of controlled clinical trials. Riboflavin is frequently used in trials as a marker of adherence. It can be combined with study medication and is excreted in urine where it fluoresces under UV light. This study compares qualitative visual inspection of fluorescence to quantitative fluorometric analysis of riboflavin concentration in its ability to detect the presence of riboflavin in urine. Methods Twenty-four volunteers received 0 mg, 25 mg, and 50 mg doses of riboflavin under single-blind conditions, with 20 also receiving a 100 mg dose. Five serial urine samples were collected over the following 36 hours. Quantitative measurement of riboflavin by fluorometric analysis and qualitative assessment of each sample using visual inspection were performed. Results The overall false positive rate for qualitative assessment was 53%. For quantitative assessment, a riboflavin concentration of 900 ng/mL was established to classify positive samples. More than 80% of samples were positive 2 to 24 hours following ingestion of 25 mg and 50 mg, and less than 80% were positive at 36 hours. At least 95% of observations for the 100 mg dose were above 900 ng/mL at all timepoints. Conclusions Quantitative fluorometric assessment is superior to qualitative visual inspection alone in determining medication adherence. The combination of 25–50 mg of daily riboflavin and a cut-off level of 900 ng/mL allows for the acceptable sensitivity of missing detection of non-compliant participants while preserving a high level of power to detect all cases of medication compliance.

No abstract

No abstract