Robrina Walker

Stimulant Reduction Intervention using Dosed Exercise (STRIDE) - CTN 0037: Study protocol for a randomized controlled trial

BackgroundThere is a need for novel approaches to the treatment of stimulant abuse and dependence. Clinical data examining the use of exercise as a treatment for the abuse of nicotine, alcohol, and other substances suggest that exercise may be a beneficial treatment for stimulant abuse, with direct effects on decreased use and craving. In addition, exercise has the potential to improve other health domains that may be adversely affected by stimulant use or its treatment, such as sleep disturbance, cognitive function, mood, weight gain, quality of life, and anhedonia, since it has been shown to improve many of these domains in a number of other clinical disorders. Furthermore, neurobiological evidence provides plausible mechanisms by which exercise could positively affect treatment outcomes. The current manuscript presents the rationale, design considerations, and study design of the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) CTN-0037 Stimulant Reduction Intervention using Dosed Exercise (STRIDE) study.Methods/DesignSTRIDE is a multisite randomized clinical trial that compares exercise to health education as potential treatments for stimulant abuse or dependence. This study will evaluate individuals diagnosed with stimulant abuse or dependence who are receiving treatment in a residential setting. Three hundred and thirty eligible and interested participants who provide informed consent will be randomized to one of two treatment arms: Vigorous Intensity High Dose Exercise Augmentation (DEI) or Health Education Intervention Augmentation (HEI). Both groups will receive TAU (i.e., usual care). The treatment arms are structured such that the quantity of visits is similar to allow for equivalent contact between groups. In both arms, participants will begin with supervised sessions 3 times per week during the 12-week acute phase of the study. Supervised sessions will be conducted as one-on-one (i.e., individual) sessions, although other participants may be exercising at the same time. Following the 12-week acute phase, participants will begin a 6-month continuation phase during which time they will attend one weekly supervised DEI or HEI session.Clinical Trials RegistryClinicalTrials.gov, NCT01141608http://clinicaltrials.gov/ct2/show/NCT01141608?term=Stimulant+Reduction+Intervention+using+Dosed+Exercise&rank=1

Disseminating contingency management to increase attendance in two community substance abuse treatment centers: lessons learned.

Although contingency management (CM) has been shown to be effective in substance use treatments, community adoption has been slow. To increase dissemination of CM into community practice, two community treatment programs collaborated with university faculty investigators to design, implement, and evaluate low-cost, prize-based CM interventions delivered by treatment staff using Petrys (2000) fishbowl technique. A pre-post study design was used to evaluate the impact of CM on outpatient group attendance. All clients attending the targeted outpatient groups at both treatment programs were eligible to participate. Group attendance was significantly positively impacted after intervention implementation. This is one of the first studies demonstrating successful implementation of CM by community treatment program counselors within their existing treatment groups. The discussion focuses on practical lessons learned during the planning and implementation of the interventions.

Study design to examine the potential role of assessment reactivity in the Screening, Motivational Assessment, Referral, and Treatment in Emergency Departments (SMART-ED) protocol

BackgroundScreening, brief intervention, and referral to treatment (SBIRT) approaches to reducing hazardous alcohol and illicit drug use have been assessed in a variety of health care settings, including primary care, trauma centers, and emergency departments. A major methodological concern in these trials, however, is “assessment reactivity,” the hypothesized impact of intensive research assessments to reduce alcohol and drug use and thus mask the purported efficacy of the interventions under scrutiny. Thus, it has been recommended that prospective research designs take assessment reactivity into account. The present article describes the design of the National Institute on Drug Abuse Clinical Trials Network protocol, Screening, Motivational Assessment, Referral, and Treatment in Emergency Departments (SMART-ED), which addresses the potential bias of assessment reactivity.Methods/designThe protocol employs a 3-arm design. Following an initial brief screening, individuals identified as positive cases are consented, asked to provide demographic and locator information, and randomly assigned to one of the three conditions: minimal screening only, screening + assessment, or screening + assessment + brief intervention. In a two-stage process, the randomization procedure first reveals whether or not the participant will be in the minimal-screening-only condition. Participants in the other two groups receive a more extensive baseline assessment before it is revealed whether they have been randomized to also receive a brief intervention. Comparing the screening only and screening + assessment conditions will allow determination of the incremental effect of assessment reactivity.DiscussionAssessment reactivity is a potential source of bias that may reduce and/or lead to an underestimation of the purported effectiveness of brief interventions. From a methodological perspective, it needs to be accounted for in research designs. The SMART-ED design offers an approach to minimize assessment reactivity as a potential source of bias. Elucidating the role of assessment reactivity may offer insights into the mechanisms underlying SBIRT as well as suggest clinical options incorporating assessment reactivity as a treatment adjunct.ClinicalTrials.gov IdentifierNCT01207791.

Design of NIDA CTN Protocol 0047: Screening, Motivational Assessment, Referral, and Treatment in Emergency Departments (SMART-ED)

Background: Medical settings such as emergency departments (EDs) present an opportunity to identify and provide services for individuals with substance use problems who might otherwise never receive any form of assessment, referral, or intervention. Although screening, brief intervention, and referral to treatment models have been extensively studied and are considered effective for individuals with alcohol problems presenting in EDs and other medical settings, the efficacy of such interventions has not been established for drug users presenting in EDs. Objectives: This article describes the design of a NIDA Clinical Trials Network protocol testing the efficacy of an screening, brief intervention, and referral to treatment model in medical EDs, highlighting considerations that are pertinent to the design of other studies targeting substance use behaviors in medical treatment settings. Methods: The protocol is described, and critical design decisions are discussed. Results: Design challenges included defining treatment conditions, study population, and site characteristics; developing the screening process; choosing the primary outcome; balancing brevity and comprehensiveness of assessment; and selecting the strategy for statistical analysis. Conclusion: Many of the issues arising in the design of this study will be relevant to future studies of interventions for addictions in medical settings. Scientific Significance: Optimal trial design is critical to determining how best to integrate substance abuse interventions into medical care.

Family Discord is Associated with Increased Substance Use for Pregnant Substance Users

Childhood abuse and partner violence are associated with prenatal substance abuse, but the potential impact of current family discord, which reflects broader family relationships and encompasses problems less severe than violence, has had little evaluation in pregnant substance users. Using data from 196 pregnant substance users participating in a NIDA Clinical Trials Network randomized clinical trial, we examined the relationship of baseline family discord to substance use and treatment session attendance. Family discord was assessed using items from the family composite of the Addiction Severity Index. Substance use was assessed by the Substance Use Calendar and urine drug screens (UDS). Assessments were weekly for four weeks and at two- and four-month post-randomization. Women with family discord were more likely to report living with a problematic substance user, reported a higher percentage of substance use days throughout each study phase, had a greater proportion of positive UDS over the four-month study period, and attended more weeks of treatment during the first month. Specific treatment interventions targeting pregnant women with family discord may be warranted.

Stress Moderates the Effect of Childhood Trauma and Adversity on Recent Drinking in Treatment-Seeking Alcohol-Dependent Men

OBJECTIVE This study sought to clarify the relationship between childhood trauma and adversity with later alcohol consumption and the moderating effects of adult psychosocial stress. METHOD Seventy-seven recently abstinent alcohol-dependent men attending residential treatment programs were assessed. Childhood trauma/adversity was assessed with the Childhood Trauma Questionnaire (CTQ), drinks per drinking day (DDD) with the Timeline Follow Back, and chronic psychosocial stress with the UCLA Stress Interview. Drinking and stress were retrospectively assessed for 6 months prior to the present treatment episode. Direct associations between childhood trauma/adversity and alcohol consumption and the moderating effects of recent psychosocial stress were assessed. All measures were considered as continuous variables. RESULTS Pretreatment drinking severity (DDD) was associated with CTQ Total score (p = .009) and the Emotional Abuse (p < .001) and Physical Abuse (p < .01) subscales. UCLA Total Stress significantly moderated the effects of CTQ Total score on drinking severity (p = .04). Whereas higher CTQ scores were significantly associated with a greater amount of pretreatment drinking in participants with high UCLA stress scores (p = .01), CTQ scores were not associated with the amount of drinking in those with low UCLA stress scores (p = .63). CONCLUSIONS Childhood trauma predicts drinking severity in alcohol-dependent men, and this effect is stronger in participants with ongoing stress in adult life. These findings suggest that early childhood trauma/adversity may sensitize stress-response systems.

Opioid withdrawal, craving, and use during and after outpatient buprenorphine stabilization and taper: A discrete survival and growth mixture model

INTRODUCTION Most patients relapse to opioids within one month of opioid agonist detoxification, making the antecedents and parallel processes of first use critical for investigation. Craving and withdrawal are often studied in relationship to opioid outcomes, and a novel analytic strategy applied to these two phenomena may indicate targeted intervention strategies. METHODS Specifically, this secondary data analysis of the Prescription Opioid Addiction Treatment Study used a discrete-time mixture analysis with time-to-first opioid use (survival) simultaneously predicted by craving and withdrawal growth trajectories. This analysis characterized heterogeneity among prescription opioid-dependent individuals (N=653) into latent classes (i.e., latent class analysis [LCA]) during and after buprenorphine/naloxone stabilization and taper. RESULTS A 4-latent class solution was selected for overall model fit and clinical parsimony. In order of shortest to longest time-to-first use, the 4 classes were characterized as 1) high craving and withdrawal, 2) intermediate craving and withdrawal, 3) high initial craving with low craving and withdrawal trajectories and 4) a low initial craving with low craving and withdrawal trajectories. Odds ratio calculations showed statistically significant differences in time-to-first use across classes. CONCLUSIONS Generally, participants with lower baseline levels and greater decreases in craving and withdrawal during stabilization combined with slower craving and withdrawal rebound during buprenorphine taper remained opioid-free longer. This exploratory work expanded on the importance of monitoring craving and withdrawal during buprenorphine induction, stabilization, and taper. Future research may allow individually tailored and timely interventions to be developed to extend time-to-first opioid use.

Protective behavioral strategies mediate problem-focused coping and alcohol use in college students

OBJECTIVE Protective behavioral strategies have emerged as a construct protective against alcohol use. The current study examines the theoretical associations among general coping styles, protective behavioral strategies, drinking to cope motives, and alcohol use in college students. METHOD Analyses of fully latent variables were conducted using structural equation modeling in a sample of 327 college students. RESULTS Protective behavioral strategies partially mediated the association between problem-focused coping and alcohol use. Behaviorally oriented problem-focused coping strategies accounted for the positive relationship between problem-focused coping and protective behavioral strategies whereas cognitively oriented problem-focused coping strategies were associated with less use of protective behavioral strategies and increased alcohol use. CONCLUSIONS This is the first study to find that protective behavioral strategies are more likely to be used by college students who endorse using a problem-focused coping style, especially if they tend to use behaviorally oriented problem-focused coping strategies. These findings extend the literature on protective behavioral strategies and indicate that students less likely to use problem-focused coping skills to deal with stress in general may need additional interventions to increase their use of protective behavioral strategies.

Randomized controlled trial comparing exercise to health education for stimulant use disorder: Results from the CTN-0037 STimulant reduction intervention using dosed exercise (STRIDE) study

OBJECTIVE To evaluate exercise as a treatment for stimulant use disorders. METHODS The STimulant Reduction Intervention using Dosed Exercise (STRIDE) study was a randomized clinical trial conducted in 9 residential addiction treatment programs across the United States from July 2010 to February 2013. Of 497 adults referred to the study, 302 met all eligibility criteria, including DSM-IV criteria for stimulant abuse and/or dependence, and were randomized to either a dosed exercise intervention (Exercise) or a health education intervention (Health Education) control, both augmenting treatment as usual and conducted thrice weekly for 12 weeks. The primary outcome of percent stimulant abstinent days during study weeks 4 to 12 was estimated using a novel algorithm adjustment incorporating self-reported Timeline Followback (TLFB) stimulant use and urine drug screen (UDS) data. RESULTS Mean percent of abstinent days based on TLFB was 90.8% (SD = 16.4%) for Exercise and 91.6% (SD = 14.7%) for Health Education participants. Percent of abstinent days using the eliminate contradiction (ELCON) algorithm was 75.6% (SD = 27.4%) for Exercise and 77.3% (SD = 25.1%) for Health Education. The primary intent-to-treat analysis, using a mixed model controlling for site and the ELCON algorithm, produced no treatment effect (P = .60). In post hoc analyses controlling for treatment adherence and baseline stimulant use, Exercise participants had a 4.8% higher abstinence rate (78.7%) compared to Health Education participants (73.9%) (P = .03, number needed to treat = 7.2). CONCLUSIONS The primary analysis indicated no significant difference between exercise and health education. Adjustment for intervention adherence showed modestly but significantly higher percent of abstinent days in the exercise group, suggesting that exercise may improve outcomes for stimulant users who have better adherence to an exercise dose. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT01141608.

Self-rated measure of pain frequency, intensity, and burden: Psychometric properties of a new instrument for the assessment of pain

BACKGROUND A brief, self-administered measurement of pain frequency, intensity, and burden is desirable in both research and clinical settings. We describe the development and initial psychometric properties of a new instrument, the Pain Frequency, Intensity, and Burden Scale (P-FIBS). METHODS The P-FIBS was administered to all participants (N = 302) with psychostimulant use disorders in the National Institute on Drug Abuse Clinical Trials Networks STRIDE (Stimulant Reduction Intervention using Dose Exercise) multisite trial. RESULTS The four items on the P-FIBS demonstrate high item-total correlations (range 0.70-0.85) with a high Cronbachs alpha (0.90). The P-FIBS demonstrated a strong negative correlation with the bodily pain sub-score of the Short Form Health Survey (r = -0.76, p < 0.0001) and did not correlate with a measure of cocaine (r = 0.09, p = 0.12) or methamphetamine (r = -0.06, p = 0.33) craving. CONCLUSIONS The P-FIBS demonstrates good psychometric properties. This brief measure can be used to assess pain in research settings or as a screen in clinical settings. Further research is needed to assess the measures sensitivity to change with treatment.