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BackgroundThe United States continues to experience an alarming rise in opioid use that includes women who become pregnant and related neonatal abstinence syndrome (NAS) in newborns. Most newborns experiencing NAS require nonpharmacological care, which entails, most importantly, maternal involvement with the newborn. To facilitate positive maternal-newborn interactions, mothers need to learn effective caregiving NAS strategies when they are pregnant; however, an enormous gap exists in the early education of mothers on the symptoms and progression of NAS, partly because no education, training, or other interventions exist to prepare future mothers for the challenges of caring for their newborns at risk for NAS. ObjectiveIn this paper, we describe a mixed methods, multistage study to adapt an existing mobile NAS tool for high-risk pregnant women and assess its usability, acceptability, and feasibility in a small randomized controlled trial. MethodsStage 1 will include 20 semistructured interviews with a panel of neonatology experts, NAS care providers, and mothers with experience caring for NAS-affected newborns to gather their recommendations on the management of NAS and explore their perspectives on the care of these newborns. The findings will guide the adaptation of existing mobile NAS tools for high-risk pregnant women. In stage 2, we will test the usability, acceptability, and feasibility of the adapted mobile tool via surveys with 10 pregnant women receiving opioid agonist therapy (OAT). Finally, in stage 3, we will randomize 30 high-risk pregnant women receiving OAT to either receive the adapted mobile NAS caregiving tool or usual care. We will compare these women on primary outcomes—maternal drug relapse and OAT continuation—and secondary outcomes—maternal-newborn bonding; length of newborn hospital stays; readmission rates; breastfeeding initiation and duration; and postpartum depression and anxiety at 4, 8, and 12 weeks postpartum. ResultsThis project was funded in July 2020 and approved by the institutional review board in April 2020. Data collection for stage 1 began in December 2020, and as of January 2021, we completed 18 semistructured interviews (10 with NAS providers and 8 with perinatal women receiving OAT). Common themes from all interviews will be analyzed in spring 2021 to inform the adaptation of the NAS caregiving tool. The results from stage 1 are expected to be published in summer 2021. Stage 2 data collection will commence in fall 2021. ConclusionsThe findings of this study have the potential to improve NAS care and maternal-newborn outcomes and lead to commercialized product development. If effective, our new tool will be well suited to tailoring for other high-risk perinatal women with substance use disorders. Trial RegistrationClinicalTrials.gov NCT04783558; https://clinicaltrials.gov/ct2/show/NCT04783558 International Registered Report Identifier (IRRID)DERR1-10.2196/27382

BACKGROUND:There are sex differences in buprenorphine/naloxone clinical trials for opioid use. While women have fewer opioid-positive urine samples, relative to men, a significant decrease in opioid-positive samples was found during treatment for men, but not women. In order to inform sex-based approaches to improve treatment outcomes, research is needed to determine if opioid use, and predictors of opioid use, differs between men and women during treatment. OBJECTIVES:To test for sex differences in opioid use during a buprenorphine/naloxone clinical trial and determine if sex differences exist in the associations between addiction-related problem areas and opioid use over the course of the trial. METHOD:This secondary data analysis of the National Drug Abuse Treatment Clinical Trials Network (CTN) 0003 examined sex differences (men = 347, women = 169) in opioid-positive samples in a randomized clinical trial comparing 7-day vs. 28-day buprenorphine/naloxone tapering strategies. Addiction-related problem areas were defined by Addiction Severity-Lite (ASI-L) domain composite scores. RESULTS:Women were more likely than men to use opioids during the course of the buprenorphine/naloxone clinical trial (B = .33, p = .01) and medical issues were positively related to submitting an opioid-positive sample during treatment for women (B = 1.67, p = .01). No ASI-L domain composite score was associated with opioid-positive samples during treatment for men. CONCLUSION:Women were more likely than men to use opioids during the course of the buprenorphine/naloxone clinical trial, and medical issues predicted opioid use during treatment for women but not men. Complementary treatment for medical problems during opioid replacement therapy may benefit women.

BackgroundThe Clinical Opiate Withdrawal Scale (COWS) is used to assess withdrawal in clinical trials and practice. The aims of this study were to examine the inter-item correlations and factor structure of the COWS in opioid-dependent men and women.MethodsThis is a secondary data analysis of the National Drug Abuse Treatment Clinical Trials Network 0003, a randomized clinical trial that compared buprenorphine/naloxone tapering strategies. The trial included 11 sites in 10 US cities. Participants were opioid-dependent individuals (n=516) that had data on the COWS. The COWS at study baseline was analyzed in this study.ResultsInter-item correlations showed weak to moderate relationships among the items. A 1-factor model did not fit the data for men (comparative fit index (CFI)=.801, root mean square error of approximation (RMSEA)=.073, weighted root mean square residual (WRMR)=1.132) or women (CFI=.694, RMSEA=.071, WRMR=.933), where resting pulse rate was not related to withdrawal for men, and yawning and gooseflesh skin was not related to withdrawal for women. A reduced model comprised of only the 8 items that were significantly related to the construct of withdrawal in both men and women, and an exploratory 2-factor model, were also assessed but not retained due to inconsistencies across gender.ConclusionsWhen traditional psychometric models are applied to the COWS, it appears that the scale may not relate to a single underlying construct of withdrawal. Further research testing the hypothesized factor structure in other opioid-dependent samples is needed.

We investigated the extent to which a contingency management (CM) procedure that deducted money from a grand total available at the end of the study compared to a procedure in which money accumulated with continued abstinence from cigarette smoking. Results suggested that the procedure in which money increased contingent on abstinence resulted in a significantly greater likelihood of obtaining a clinically relevant (i.e., 48-hr) period of abstinence. In terms of attendance, participants in the condition in which monetary reinforcement accrued with consecutive instances of abstinence were significantly less likely to miss consecutive appointments than those in which money was deducted for failure to abstain. (Contains 1 figure.)

This study was a secondary data analysis of factors associated with alcohol-related child removal among American Indian/Alaska Native (AI/AN) adults enrolled in a clinical trial of an alcohol intervention. Among 326 parent participants, 40% reported ever having a child removed from their care in part because of the parent's alcohol use, defined here as alcohol-related child removal. Seventy-five percent of parents reported at least one separation during their own childhood (M = 1.3, SD = 1.0). In a multivariable analysis, alcohol-related child removal was associated with parental boarding school attendance. No relationship was found between alcohol-related child removal and alcohol intervention outcomes. Results may provide evidence of multigenerational child removal impacts of boarding schools on AI/AN adults receiving an alcohol use disorder intervention. Assessment of parental history of child removal by practitioners, strategies to prevent alcohol-related separation and to support reunification should be integrated into addiction treatment in AI/AN communities. [ABSTRACT FROM AUTHOR]

Gamma-hydroxybutyrate (GHB) is a drug with significant abuse potential. The present study aimed to assess the relative value of escalating doses of GHB to current GHB users via the Multiple Choice Procedure (MCP), and to validate that the dose rated highest with the MCP would be self-administered at a greater rate than placebo. Participants were 5 current GHB users who were not currently trying to stop using GHB. To examine the value of escalating doses of GHB, the following doses of GHB were used: 0 (placebo), 12.5, 25, 37.5, and 50 mg/kg. Participants typically assigned higher doses of GHB had higher crossover points on the MCP. During choice sessions, participants made repeated choices between administering GHB, placebo or nothing. All participants selected GHB exclusively (5 out of 5 instances) except for one participant who selected GHB on 4 out of 5 instances, thus 96% (i.e., 24/25) of choices were for active GHB. Based on these data, GHB appears likely to function as a dose-dependent reinforcer for humans based on our sample. (Contains 2 figures.)

Drugs, including alcohol, that are abused function as powerful reinforcers. Effective drug and alcohol addiction treatments decrease the reinforcing efficacy of the abused substance. Reinforcing efficacy arises from a variety of sources, documentation of which may aid in designing treatment and prevention interventions. Understanding the origin of the reinforcing efficacy may also prove useful in understanding both the initiation and maintenance of drug-taking behavior. This article reports results from 2 studies conducted to begin examining the degree to which postingestive consequences alter the reinforcing efficacy of alcohol. Participants consumed identical low-dose alcohol drinks (Experiment 1) or placebo drinks (Experiment 2) and then completed a set of laboratory tasks designed to mimic drug impairment or enhancement of performance. Following this, participants could choose to consume one of the drinks. Participants generally selected the beverage that had previously been associated with earning greater amounts of money. This effect was more pronounced and durable for the placebo beverage than for the low-dose alcohol beverage. (Contains 2 tables.)