Erin L. Winstanley

A Systematic Review of Community Opioid Overdose Prevention and Naloxone Distribution Programs

Community-based opioid overdose prevention programs (OOPPs) that include the distribution of naloxone have increased in response to alarmingly high overdose rates in recent years. This systematic review describes the current state of the literature on OOPPs, with particular focus on the effectiveness of these programs. We used systematic search criteria to identify relevant articles, which we abstracted and assigned a quality assessment score. Nineteen articles evaluating OOPPs met the search criteria for this systematic review. Principal findings included participant demographics, the number of naloxone administrations, percentage of survival in overdose victims receiving naloxone, post–naloxone administration outcome measures, OOPP characteristics, changes in knowledge pertaining to overdose responses, and barriers to naloxone administration during overdose responses. The current evidence from nonrandomized studies suggests that bystanders (mostly opioid users) can and will use naloxone to reverse opioid overdoses when properly trained, and that this training can be done successfully through OOPPs.

A randomized, placebo-controlled study of adjunctive ramelteon in ambulatory bipolar I disorder with manic symptoms and sleep disturbance

This study evaluated the efficacy and tolerability of ramelteon in ambulatory bipolar I disorder with manic symptoms and insomnia. Twenty-one outpatients with bipolar I disorder by Diagnostic and Statistical Manual of Mental Disorders, fourth edition criteria with mild-to-moderate manic symptoms and sleep disturbance were randomized to receive either ramelteon (N=10) or placebo (N=11) in an 8-week, double-blind, fixed-dose (8 mg/day) study. Ramelteon and placebo had similar rates of reduction in ratings of symptoms of insomnia, mania, and global severity of illness. However, ramelteon was associated with improvement in a global rating of depressive symptoms. It was also well tolerated and associated with no serious adverse events. The small sample size may have limited the ability of the study to detect potentially clinically important drug–placebo differences. Further studies of ramelteon in subgroups of bipolar patients with sleep disturbance, including those with depression or euthymia, seem indicated.

Duloxetine in the treatment of binge eating disorder with depressive disorders: A placebo‐controlled trial

OBJECTIVE This study evaluated duloxetine in the treatment of binge eating disorder (BED) with comorbid current depressive disorders. METHOD In this 12-week, double-blind, placebo-controlled trial, 40 patients with Diagnostic and Statistical Manual of Mental Disorders-IV-TR BED and a comorbid current depressive disorder received duloxetine (N = 20) or placebo (N = 20). The primary outcome measure was weekly binge eating day frequency. RESULTS In the primary analysis, duloxetine (mean 78.7 mg/day) was superior to placebo in reducing weekly frequency of binge eating days (p = .04), binge eating episodes (p = .02), weight (p = .04), and Clinical Global Impression-Severity of Illness ratings for binge eating (p = .02) and depressive disorders (p = .01). Changes in body mass index and measures of eating pathology, depression, and anxiety did not differ between the two groups. DISCUSSION Duloxetine may be effective for reducing binge eating, weight, and global severity of illness in BED with a comorbid current depressive disorder, but this finding needs confirmation in larger, placebo-controlled trials.

Acamprosate in the treatment of binge eating disorder: A placebo-controlled trial†‡§¶

OBJECTIVE To assess preliminarily the effectiveness of acamprosate in binge eating disorder (BED). METHOD In this 10-week, randomized, placebo-controlled, flexible dose trial, 40 outpatients with BED received acamprosate (N = 20) or placebo (N = 20). The primary outcome measure was binge eating episode frequency. RESULTS While acamprosate was not associated with a significantly greater rate of reduction in binge eating episode frequency or any other measure in the primary longitudinal analysis, in the endpoint analysis it was associated with statistically significant improvements in binge day frequency and measures of obsessive-compulsiveness of binge eating, food craving, and quality of life. Among completers, weight and BMI decreased slightly in the acamprosate group but increased in the placebo group. DISCUSSION Although acamprosate did not separate from placebo on any outcome variable in the longitudinal analysis, results of the endpoint and completer analyses suggest the drug may have some utility in BED.

A randomized controlled trial of fluoxetine in the treatment of cocaine dependence among methadone-maintained patients

BACKGROUND Cocaine abuse and dependence continue to be widespread. Currently, there are no pharmacotherapies shown to be effective in the treatment of cocaine dependence. METHODS A 33-week outpatient clinical trial of fluoxetine (60 mg/day, po) for cocaine dependence that incorporated abstinence-contingent voucher incentives was conducted. Participants (N = 145) were both cocaine and opioid dependent and treated with methadone. A stratified randomization procedure assigned subjects to one of four conditions: fluoxetine plus voucher incentives (FV), placebo plus voucher incentives (PV), fluoxetine without vouchers (F), and placebo without vouchers (P). Dosing of fluoxetine/placebo was double blind. Primary outcomes were treatment retention and cocaine use based on thrice-weekly urine testing. RESULTS The PV group had the longest treatment retention (M = 165 days) and lowest probability of cocaine use. The adjusted predicted probabilities of cocaine use were 65% in the P group, 60% in the F group, 56% in the FV group, and 31% in the PV group. CONCLUSIONS Fluoxetine was not efficacious in reducing cocaine use in patients dually dependent on cocaine and opioids.

A randomized, placebo-controlled study of zonisamide to prevent olanzapine-associated weight gain.

Abstract Weight gain is commonly observed with olanzapine treatment. Zonisamide is an antiepileptic drug associated with weight loss. This study examined the effectiveness of zonisamide in preventing weight gain in 42 patients beginning olanzapine for bipolar disorder or schizophrenia. Each patient had a body mass index of 22 mg/kg2 or greater and was randomized to taking olanzapine with either zonisamide (n = 20) or placebo (n = 22) for 16 weeks. The primary outcome measure was change in body weight in kilograms from baseline. In the primary analysis using longitudinal regression, patients who received zonisamide had a significantly slower rate of weight gain and increase in body mass index than those who received placebo. The patients treated with zonisamide gained a mean (SD) of 0.9 (3.3) kg, whereas those treated with placebo gained a mean (SD) of 5.0 (5.5) kg; P = 0.01. None of the patients in the zonisamide group, compared with 7 patients (33%) in the placebo group, gained 7% of body weight or greater from baseline (Fisher exact test, P = 0.009). The zonisamide group, however, reported significantly more cognitive impairment as an adverse event than the placebo group (25% vs 0, respectively; P = 0.02). Zonisamide was effective for mitigating weight gain in patients with bipolar disorder or schizophrenia initiating treatment with olanzapine but was associated with cognitive impairment as an adverse event.

Sodium oxybate in the treatment of binge eating disorder: an open-label, prospective study.

OBJECTIVE To assess preliminarily the effectiveness of sodium oxybate in binge eating disorder. METHOD This was an open-label, prospective, 16-week, flexible dose study of sodium oxybate in binge eating disorder. The primary outcome was binge eating episode frequency. RESULTS Twelve individuals received sodium oxybate, 10 completed at least one postbaseline evaluation, and five completed the study. Mean dose at endpoint was 7.1 (2.0) g/day. Sodium oxybate was associated with significant reductions in frequency of binge days and binge episodes, as well as measures of clinical severity, eating pathology, obsessive-compulsive symptoms, food cravings, body mass index, and body weight. Nine participants had remission of binge eating and five lost ≥5% of their baseline weight; all five of the latter participants had remission of binge eating. DISCUSSION In this open-label trial, sodium oxybate was effective in binge eating disorder, but associated with high a discontinuation rate.

Placebo-controlled study of quetiapine monotherapy in ambulatory bipolar spectrum disorder with moderate-to-severe hypomania or mild mania☆

BACKGROUND There are no randomized, placebo-controlled data for quetiapine in outpatients with bipolar spectrum disorder (ambulatory BSD) and moderate-to-severe hypomanic or mild manic symptoms (hypomania/mild mania). METHODS An 8-week, randomized, double-blind, placebo-controlled trial of quetiapine in ambulatory BSD with hypomanic/mild manic symptoms, defined operationally as a score of >or=3 but <5 on the mania subscale of the Clinical Global Impressions Scale Modified for Bipolar Illness (CGI-BP) at baseline and one prior study visit, at least 3 days but no more than 2 weeks apart. The primary outcome measure was the rate of change in the Young Mania Rating Scale score (YMRS). RESULTS During the 8-week study period, patients receiving quetiapine (average daily dose=232mg) had a marginally greater rate of reduction in mean total YMRS score than patients receiving placebo (p=0.06). Additionally, CGI-BP mania (p=0.01) and the CGI-BP overall (p<0.001) scores were significantly reduced and the CGI-depression score (p=0.08) was marginally reduced in the quetiapine group. Six (32%) quetiapine patients and 8 (40%) placebo patients did not complete the trial. LIMITATIONS Small sample size and high attrition (36%). CONCLUSION Quetiapine was marginally more effective than placebo in reducing hypomanic/mild manic symptoms in ambulatory BSD as assessed by the YMRS. It was more effective than placebo in reducing manic symptoms and global bipolar symptoms as assessed by the CGI-BP. The drugs discontinuation rate was similar to placebos. Controlled trials of quetiapine and other compounds with mood stabilizing properties in larger groups of ambulatory BSD patients with hypomanic/mild manic symptoms appear warranted.

The potential impact of recruitment method on sample characteristics and treatment outcomes in a psychosocial trial for women with co-occurring substance use disorder and PTSD.

BACKGROUND Recruitment method can impact the sample composition of a clinical trial and, thus, the generalizability of the results, but the importance of recruitment method in substance use disorder trials has received little attention. The present paper sought to address this research gap by evaluating the association between recruitment method and sample characteristics and treatment outcomes in a substance use disorder trial. METHODS In a multi-site trial evaluating Seeking Safety (SS), relative to Womens Health Education (WHE), for women with co-occurring PTSD (either sub-threshold or full PTSD) and substance use disorders, one site assessed the method by which each participant was recruited. Data from this site (n=106), which recruited participants from newspaper advertising and clinic intakes, were analyzed. RESULTS Participants recruited through advertising, relative to those from the clinic, had significantly higher levels of baseline drug use and higher rates of meeting DSM-IV-TR criteria for full PTSD. Results suggest that the effectiveness of SS in decreasing PTSD symptoms was greater for participants recruited through advertising relative to those recruited from the clinic. Conversely, the results revealed a significant treatment effect in the clinic-recruited participants, not seen in the advertising-recruited participants, with SS, relative to WHE, participants being more likely to report past week drug use during the follow-up phase. CONCLUSION Recruitment method may impact sample composition and treatment effects. Replication of this finding would have important implications for substance use disorder efficacy trials which often utilize advertising to recruit participants.

Drug abuse and HIV/AIDS: international research lessons and imperatives.

Drug use and abuse have been, and continue to be, intrinsically linked to the transmission of HIV/AIDS in the USA and around the world. There is no greater public health goal for addiction researchers than to help stem the continued spread of these intertwined epidemics. Illicit drug use-related transmission of HIV accounts for at least onethird of HIV/AIDS cases in the USA. Drug use behaviors that contribute to HIV transmission include not only sharing contaminated injection equipment but also risky sexual behaviors among injection drug users (IDUs) or their noninjecting sex partners and perinatal transmission to their offspring. In addition, research shows that use of drugs, injected or not, can affect decisionmaking particularly about negotiating condom use that can endanger ones health and the health of others. Although similar statistics are generally not available in most other countries around