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Background and aims Pioglitazone (PIO), a potent agonist of PPAR-gamma, is a promising candidate treatment for cocaine use disorder (CUD). We tested the effects of PIO on targeted mechanisms relevant to CUD: cocaine craving and brain white matter (WM) integrity. Feasibility, medication compliance and tolerability were evaluated. Design Two-arm double-blind randomized controlled proof-of-concept pilot trial of PIO or placebo (PLC). Setting Single-site out-patient treatment research clinic in Houston, TX, USA. Participants Thirty treatment-seeking adults, 18 to 60 years old, with CUD. Eighteen participants (8 = PIO; 10 = PLC) completed diffusion tensor imaging (DTI) of WM integrity at pre-/post-treatment. Intervention Study medication was dispensed at thrice weekly visits along with once-weekly cognitive behavioral therapy for 12 weeks. Measurements Measures of target engagement mechanisms of interest included cocaine craving assessed by the Brief Substance Craving Scale (BSCS), the Obsessive Compulsive Drug Use Scale (OCDUS), a visual analog scale (VAS) and change in WM integrity. Feasibility measures included number completing treatment, medication compliance (riboflavin detection) and tolerability (side effects, serious adverse events). Findings Target engagement change in mechanisms of interest, defined as a ≥ 0.75 Bayesian posterior probability of an interaction existing favoring PIO over PLC, was demonstrated on measures of craving (BSCS, VAS) and WM integrity indexed by fractional anisotropy (FA) values. Outcomes indicated greater decrease in craving and greater increase in FA values in the PIO group. Feasibility was demonstrated by high completion rates among those starting treatment (21/26 = 80%) and medication compliance (≥ 80%). There were no reported serious adverse events for PIO. Conclusions Compared with placebo, patients receiving pioglitazone show a higher likelihood of reduced cocaine craving and improved brain white matter integrity as a function of time in treatment. Pioglitazone shows good feasibility as a treatment for cocaine use disorder. [ABSTRACT FROM AUTHOR]

This study examined the relationship between smoking, drinking and heavy caffeine use (> three caffeinated drinks per day) among pregnant women who reported smoking cigarettes and drinking alcohol prior to conception. Demographic predictors of smoking, drinking and caffeine use during pregnancy were also identified. Pregnant women (n = 237) attending a university-based, public clinic were identified during screening for a larger intervention study. Logistic regression analyses revealed a significant relationship between pregnancy smoking and drinking (OR= 8.1), as well as between smoking and harmful caffeine use (OR=3.1). Age predicted smoking and drinking in pregnancy, with older women being more likely to use both substances. Caucasian women were more likely to continue smoking, while African-American women were more likely to continue drinking. Increased attention should be paid to the co-occurrence of multiple health risk behaviours during pregnancy and to the specific needs of subgroups of high-risk women.