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Abstract: High levels of missing outcome data for biologically confirmed substance use (BCSU) threaten the validity of substance use disorder (SUD) clinical trials. Underlying attributes of clinical trials could explain BCSU missingness and identify targets for improved trial design. We reviewed 21 clinical trials funded by the NIDA National Drug Abuse Treatment Clinical Trials Network (CTN) and published from 2005 to 2018 that examined pharmacologic and psychosocial interventions for SUD. We used configurational analysis-a Boolean algebra approach that identifies an attribute or combination of attributes predictive of an outcome-to identify trial design features and participant characteristics associated with high levels of BCSU missingness. Associations were identified by configuration complexity, consistency, coverage, and robustness. We limited results using a consistency threshold of 0.75 and summarized model fit using the product of consistency and coverage. For trial design features, the final solution consisted of two pathways: psychosocial treatment as a trial intervention OR larger trial arm size (complexity=2, consistency=0.79, coverage=0.93, robustness score=0.71). For participant characteristics, the final solution consisted of two pathways: interventions targeting individuals with poly- or nonspecific substance use OR younger age (complexity=2, consistency=0.75, coverage=0.86, robustness score=1.00). Conclusions: Psychosocial treatments, larger trial arm size, interventions targeting individuals with poly- or nonspecific substance use, and younger age among trial participants were predictive of missing BCSU data in SUD clinical trials. Interventions to mitigate missing data that focus on these attributes may reduce threats to validity and improve utility of SUD clinical trials. Related protocols: CTN-0002, CTN-0003, CTN-0004, CTN-0006, CTN-0007, CTN-0009. CTN-0013, CTN-0014, CTN-0015, CTN-0017, CTN-0021, CTN-0029, CTN-0030, CTN-0031, CTN-0037, CTN-0044, CTN-0046, CTN-0048, CTN-0051, CTN-0053

Abstract:

The lack of a consensus on empirically supported and clinically meaningful outcome measures for stimulant use disorders (SUDs) continues to undermine the development and evaluation of effective behavioral and pharmacological treatment options. The aim of this study was to evaluate the clinical relevance of four stimulant use treatment outcome measures (longest curation of abstinence, percent of negative urinalysis submitted, abstinent in the last 2 weeks of treatment, and 3 or more weeks of continuous abstinence) by exploring their utility via association with stimulant and alcohol use, employment and legal problems, and severity of psychiatric symptomatology collected at follow-up.

Data used in these secondary analyses came from a multisite randomized contingency management treatment trial for SUDs (n=441) conducted through the NIDA Clinical Trials Network (CTN-0006). Multiple regression analyses were conducted to explore the association of 4 stimulant use treatment outcome measures and 8 3-month follow-up outcomes. Both dichotomous outcome measures showed similar performances being significantly associated with 4 follow-up outcomes. All outcome measures were consistently associated with better outcome responses at the 3-month follow-up, adding support to their clinical relevance and their adoption in SUD treatment trials. The two dichotomous outcome measures are reliable candidates to be used as endpoint outcomes, as recommended by the U.S. Food and Drug Administration (FDA).

Conclusions: The identification of clinically meaningful indicators of treatment response can promote important advances in the development of more effective treatments for stimulant use disorders (SUDs). These findings offer empirical support for the use of specific treatment outcome measures by determining their associations to clinically relevant 3-month follow-up outcomes.

Related protocols: CTN-0006

Abstract:

The extent to which behavioral drug abuse treatments affect sexual risk behaviors is largely unknown. This study examined the impact of behavioral drug abuse treatments on sexual risk behaviors using an integrative data analysis approach across eight trials conducted within the NIDA Clinical Trials Network (CTN-0004, 0005, 0006, 0007, 0009, 0013, 0015, and 0021). Participants (N=1305) from eight randomized controlled trials who were sexually active at baseline were included in the pooled dataset; 48.7% were female, 64.1% self-identified as a racial/ethnic minority, with M (SD) age of 34.9 (9.6). Longitudinal logistic regression estimated the probability of risky sexual behavior (i.e., inconsistent condom use and/or > 1 sexual partner in past 30 days) post-intervention with an indicator variable (1 for post-intervention), study condition (control, intervention), and their interaction as predictors; the analysis employed random effects for each trial and included relevant control variables. Time-varying differences in effects based on weeks post-intervention were incorporated using interacted linear and quadratic terms with condition status. Approximately 84.2% reported risky sexual behaviors at baseline. The control and intervention conditions were 18.5 and 17.3 percentage points less likely to report risky sexual behavior post-intervention, respectively.

Conclusions: Results suggest decreasing rates of risky sex engagement until 8 weeks (control) or 9 weeks (intervention post-intervention; risky sexual behavior subsequently increased. Behavioral CTN trial participation was associated with decreased sexual risk behaviors in both the intervention and control trial conditions. Given the heterogeneity of treatment approaches employed across the 8 CTN trials, these results point to the effectiveness of behavioral drug abuse treatment to reduce sexual risk behaviors. To bolster further reductions in sexual risk behavior engagement, there is a need to identify HIV risk reduction interventions that can best be integrated within existing resource-limited substance use disorder treatment programs.

Related protocols: CTN-0004, CTN-0005, CTN-0006, CTN-0007, CTN-0009, CTN-0013, CTN-0015, CTN-0021

Abstract:

The primary aim of this study was to examine stimulant use and longitudinal treatment attendance in one “parallel outcomes” model in order to determine how these two outcomes are related to one another during treatment, and to quantify how the intervention impacts these two on- and off-target outcomes differently. Data came from two multi-site randomized clinical trials (RCTs) of contingency management (CM) that targeted stimulant use. Parallel multilevel modeling was used to examine the impact of multiple pre-specified covariates, including selected Addiction Severity Index (ASI) scores, age and sex, in addition to CM on concurrent attendance and stimulant use in two separate analyses, i.e., one per trial. In one trial, CM was positively associated with attending treatment throughout the trial. In the second trial, CM predicted negative urinalysis (UA) over the 12-week treatment period. In both trials, there was a significant, positive relationship between attendance and UA submission, but in the first trial a UA at both baseline and over time was related to attendance over time, and in the second trial, a UA submission at baseline was associated with increased attendance over time.

Conclusions: These findings indicate that stimulant use and treatment attendance over time are related but distinct outcomes that, when analyzed simultaneously, portray a more informative picture of their predictors and the separate trajectories of each. This “indirect reinforcement” between two clinically meaningful on-target (directly reinforced behavior) and off-target (indirectly reinforced behavior) outcomes is in need of further examination in order to fully exploit the potential clinical benefits that could be realized in substance use disorder treatment trials.

Related protocols: CTN-0006, CTN-0007

Abstract:

Despite research demonstrating its effectiveness, use of contingency management (CM) in substance use disorder treatment has been limited. Given the vital role that counselors play as arbiters in the use of therapies, examination of their use of and attitudes toward CM could provide insight into how to better promote further use of the intervention. This paper examines 731 counselors’ attitudes toward the effectiveness and acceptability of CM in treatment, as well as their specific attitudes toward both unspecified and tangible incentives for treatment attendance and abstinence. Compared to cognitive behavioral therapy, motivational interviewing, and community reinforcement approach, counselors rated CM as the least effective and least acceptable psychosocial intervention. Exposure through use of CM in a counselor’s employing organization was positively associated with perceptions of acceptability, agreement that incentives have a positive effect on the client-counselor relationship, and endorsement of tangible incentives for abstinence. Endorsement of tangible incentives for treatment attendance was significantly greater among counselors with more years in the treatment field, and counselors who held at least a Master’s degree. Counselors’ adaptability or openness to innovations was also positively associated with attitudes toward CM. Further, female counselors and counselors with a greater 12-step philosophy were less likely to endorse the use of incentives.

A highlight of this study is that it offers the first specific assessment of the impact of “Promoting Awareness of Motivational Incentives” (PAMI), a web-based tool based on findings of CM protocols tested within the Clinical Trials Network (CTN), on counselors employed outside the CTN. We found that 10% of counselors had accessed PAMI, and those who had accessed PAMI were more likely to report a higher degree of perceived effectiveness of CM than those who had not.

Conclusions: The effectiveness of SUD treatment will be enhanced by the breadth of the menu of treatment offerings that are offered by providers, assuming appropriate fidelity to the design of these interventions. Given the barriers to CM adoption, identifying predictors of positive CM attitudes among counselors can help diffuse CM into routine clinical practice. Exposure is important in ensuring proper delivery of such treatment, and training could help decrease the reluctance of paying individuals for treatment attendance or abstinence. This study lays in the groundwork for vital research on the impact of multiple web-based educational strategies. Future research should focus on differential effectiveness of different educational strategies, consider the attitudes of patients themselves, and explore the orientations toward practices such as CM among third-party payers. Given the barriers to CM adoption, identifying predictors of positive attitudes among counselors can help diffuse CM into routine clinical practice.

Related protocols: CTN-0006, CTN-0007

Abstract:

This study examined the impact of contingency management (CM) on stimulant use heterogeneity across two 12-week clinical trials, National Drug Abuse Treatment Clinical Trials Network protocols CTN-0006 and CTN-0007. The hypothesis was that CM effects on stimulant use would differ across multiple sub-groups of patients with distinct trajectories of use throughout the treatment period. The outcome of positive stimulant urine analysis (UA+) was measured two times per week for 12 weeks. Growth mixture modeling was used to estimate multiple latent class solutions (classes 1 through 6). The best fitting, clinically interpretable model was the 3-class linear model (BIC=7624). The model produced the following classes: Class 1 (21% of sample) = low probability (35%) of UA+ at baseline, steep decline in UA+ submissions during treatment. Class 2 (38%) = moderate probability of UA+ at baseline (42%), moderate decline in UA+ submissions over time caused by CM. Class 3 (41%) = high probability of UA+ at baseline (65%), increase in UA+ submissions over time and no effect of CM.

Conclusions: Identifying sub-groups may help explain heterogeneity in substance use trajectories and identify characteristics that could inform treatment nonresponse (e.g. Class 3). Such models could also assist with identifying segments of the stimulant use population who could benefit from ancillary services in order to more effectively impact abstinence.

Related protocols: CTN-0006, CTN-0007

Abstract:

A substantial number of substance abusers entering outpatient psychosocial counseling treatment are referred from the criminal justice (CJ) system. This secondary analysis of previously published findings from National Drug Abuse Treatment Clinical Trials Network (CTN) protocol CTN-0006 (Motivational Incentives for Enhanced Drug Abuse Recovery: Drug Free Clinics), a large, multi-site trial of a prize-based abstinence incentive intervention, examined the influence of CJ referral on usual care outcomes and response to the incentive procedure. CJ referrals (n=138) were more likely than those not CJ referred (n=277) to provide stimulant negative urine samples whether missing samples were counted as positive or as missing. A significant interaction term was found only for percentage of treatment completers (p=0.27). On that retention variable, and three additional drug use measures, significant incentive effects were confined to participants who entered treatment without referral from the criminal justice system. Nevertheless, there were trends toward better retention and less drug use in CJ referrals who received abstinence incentives as well.

Conclusions: This study suggests that abstinence incentives should be offered as a first priority to stimulant users entering treatment without criminal justice referral. However, incentives can also be considered for use with criminal justice-referred stimulant users, based on the observation that best outcomes were obtained in CJ referrals who also received the abstinence incentive program.

Related protocols: CTN-0006

Abstract:

HIV infection disproportionately impacts minorities, yet research on racial/ethnic differences in the prevalence and correlates of HIV risk behaviors is limited. This study examined racial/ethnic differences in the rates of HIV risk behaviors and whether the relationship between HIV risk factors and HIV risk behaviors varies by race/ethnicity in clients participating in National Drug Abuse Treatment Clinical Trial Network (CTN) trials. The sample was 41% non-Hispanic White, 32% non-Hispanic Black, and 27% Hispanic (N = 2,063). HIV risk behaviors and measures of substance and psychosocial HIV risk factors in the past month were obtained. Non-Hispanic Blacks engaged in less HIV sexual risk behaviors overall than non-Hispanic Whites. While non-Hispanic Whites were the most likely to report any injection drug use, Hispanics engaged in the most HIV drug risk behaviors. Specific risk factors were differentially predictive of HIV risk behavior by race/ethnicity. Alcohol use severity was related to engaging in higher sex risk behaviors for non-Hispanic Blacks and Whites. Greater psychiatric severity was related to engaging in higher sex risk behaviors for non-Hispanic Whites. Drug use severity was associated with engaging in higher risk drug behaviors for non-Hispanic Whites and Hispanics, with the magnitude of the relationship stronger for Hispanics.

Conclusions: The findings from the present study suggest that there is a context in which HIV high risk behaviors occur within racial/ethnic groups as well as differences in the presence of risk factors associated with engaging in those behaviors. These findings are consistent with calls to culturally adapt evidence-based interventions and the need to maintain core elements of the intervention when adapting the intervention for increased relevance to the new targets. Further research testing HIV risk prevention interventions within racial/ethnic groups is needed to identify target behaviors or risk factors that are salient to inform HIV interventions.

Related protocols: CTN-0001, CTN-0002, CTN-0004, CTN-0005, CTN-0006, CTN-0007, CTN-0021

Abstract:

This article reports on an ancillary investigation of data from National Drug Abuse Treatment Clinical Trials Network protocols CTN-0006 and -0007 that aimed to identify a potential core set of brief screeners for the detection of individuals with a substance use disorder (SUD) in medical settings. Data from the two protocols, both multisite studies that evaluated stimulant use outcomes of an abstinence-based contingency management intervention as an addition to usual care, were analyzed by factor analysis, item response theory (IRT), sensitivity and specificity procedures. Alcohol and drug use disorders in 847 substance-using adults were assessed using the DSM-IV Checklist. Comparatively prevalent symptoms of dependence, especially inability to cut down for all substances, showed high sensitivity for detecting an SUD (low rate of false negative). IRT-defined severe (infrequent) and low discriminative items, especially withdrawal for alcohol, cannabis, and cocaine, had low sensitivity in identifying cases of an SUD. IRT-defined less severe (frequent) and high discriminative items, including inability to cut down or taking larger amounts than intended for all substances and withdrawal for amphetamines and opioids, showed good-to-high values of area under the receiver operating characteristic curve (ROC-AUC) in classifying cases and noncases of an SUD.

Conclusions: This study supports the value of combining IRT and ROC-AUC procedures to select psychometrically appropriate items to develop an efficient, simplified, and reasonably sensitive tool to screen for SUDs in medical settings, a development encouraged by the Affordable Care Act and the Health Information Technology for Economic and Clinical Health Act. Findings add to the evidence for initial single-item screens for alcohol or drug use that have shown good sensitivity and specificity in medical settings, and they expand prior research on the two-item screen for alcohol and drug disorders. The combined results from IRT and ROC-AUC analyses indicate the value of further testing “taking large amounts” and “inability to cut down” as part of a simplified screen to facilitate detection of problematic substance users with a high probability for having an SUD.

Supported by the Duke Clinical Research Institute (CTN DSC 1).

Related protocols: CTN-0006, CTN-0007

Abstract:

Substance abusers who enter treatment require a combination of motivation, skills and opportunities to make the behavior changes needed that will advance their recovery. One technique that has been helpful in boosting and sustaining motivation for successful participation and behavior change during treatment involves the use of tangible incentives that are awarded to clients by clinic staff contingent upon objective evidence of goal attainment. Contingency Management and Motivational Incentives are synonymous names for this technique. A large body of research provides evidence that motivational incentives, when implemented appropriately, can increase length of treatment participation and promote sustained periods of drug abstinence. Further, the technique has been shown efficacious when applied to users of a variety of abused substances including cocaine, alcohol and marijuana.

A large multi-site clinical trial conducted within the National Drug Abuse Treatment Clinical Trials Network supported effectiveness for treatment of stimulant users when abstinence-contingent incentives were added to usual care in community treatment programs that provided either psychosocial counseling alone or opiate substitution therapy (methadone) as well. Data from this trial will be used to demonstrate the magnitude and generality of these effects. Motivational incentives have been well accepted and widely adopted by substance abuse treatment researchers including those in CTN, to support adequate participation and/or to promote abstinence among research volunteers. The technique can also improve substance abuse treatment outcomes but has been less well accepted and widely adopted within the realm of clinical practice, despite being one of the most effective known behavioral interventions available for use in these settings. Nevertheless, adoption is gradually increasing as more training and dissemination materials become available and as solutions to perceived adoption impediments are addressed. During this presentation, dissemination resources will be provided and lessons learned about adoption discussed.

Related protocols: CTN-0006, CTN-0007

Abstract:

Stimulant users who sought treatment in a psychosocial outpatient treatment program participated in a multi-site 12-week randomized controlled trial (n=415) of a prize-based abstinence incentive intervention. Primary study outcomes were published previously (Petry et al., 2005); the present analysis examined the influence of criminal justice referral on treatment retention and stimulant use. In this study, participants were categorized based on study condition (incentives vs. usual care) and whether they were referred to treatment by the criminal justice system. Analyses assessed the separate and interactive effects of these factors on retention and stimulant use. Participants referred from the criminal justice system were more likely to be retained in treatment and to provide stimulant negative urine samples than those not referred from criminal justice. There was a significant interaction of criminal justice referral and incentives on treatment retention. Among voluntary referrals, those receiving abstinence incentives submitted 11.2 negative urines on average vs. 7.8 submitted by those in usual care. Among criminal justice referrals, mean number of negative urines submitted was 12.5 in those who received abstinence incentives vs. 10.3 in usual care.

Conclusions: Abstinence incentives significantly improved outcomes in voluntary but not in criminal justice referred admissions to outpatient treatment, probably due to higher base rates of retention and abstinence in the CJ referrals. Nevertheless, an additive effect of external motivation sources was seen with best outcomes in those exposed to both positive (abstinence incentives) and negative (CJ monitoring and sanctions) motivators and worst outcomes in those with neither source of external motivation.

Abstract:

This is the Results Article for CTN-0007-A-1.

This CTN platform study empirically examined opinions of treatment providers regarding contingency management (CM) programs while controlling for experience with a specific efficacious CM program. In addition to empirically describing provider opinions, the researchers examined whether the opinions of providers at the sites that implemented the CM program were more positive than those of matched providers at sites that did not implement it. Participants from 7 CM treatment sites (n=76) and 7 matched non-participating sites (n=69) within the same nodes of the National Drug Abuse Treatment Clinical Trials Network (CTN) completed the Provider Survey of Incentives (PSI), which assesses positive and negative beliefs about incentive programs. An intent-to-treat analysis found no differences in the PSI summary scores of providers in CM programs versus matched sites, but correcting for experience with tangible incentives showed significant differences, with providers from CM sites reporting more positive opinions that those from matched sites. Some differences were found in opinions regarding costs of incentives, and these generally indicated that participants from CM sites were more likely to see the costs as worthwhile. The results from the study suggest that exposing community treatment providers to incentive programs may itself be an effective strategy in prompting the dissemination of this evidence-based practice, one of the goals of NIDA’s CTN.

Related protocols: CTN-0006, CTN-0007, CTN-0007-A-1

Abstract:

Motivational Incentives: Positive Reinforcers to Enhance Successful Treatment Outcomes (MI:PRESTO) is an interactive on-line course that focuses on the process of adopting Motivational Incentives in a clinical setting. By design, this course builds upon the Addiction Technology Transfer Center Network’s Technology Transfer Conceptual Model. Highlighted within this model is a multidimensional process that promotes the use of an innovation, in this case Motivational Incentives.

This free, self-guided, online learning tool assists Clinical Supervisors and other behavioral healthcare practitioners to learn and experience how to utilize the 7 Principles of Motivational Incentives introduced in PAMI, to facilitate the adoption of Motivational Incentives as an effective evidence-based practice aimed at reducing drug abuse and promoting positive outcomes for patients.

Related protocols: CTN-0006, CTN-0007

Abstract:

Selection of appropriate outcome measures is important for clinical studies of drug addiction treatment. Researchers use various methods for collecting drug use outcomes and must consider substances to be included in a urine drug screen (UDS), accuracy of self-report, use of various instruments and procedures for collecting self-reported drug use, and timing of outcome assessments. This study sought to define a set of candidate measures to (1) assess their intercorrelation and (2) identify any differences in results. To that end, data were combined from seven completed protocols in the National Drug Abuse Treatment Clinical Trials Network (CTN), with a total of 1897 participants. Nine outcome measures were defined, based on UDS, self-report, or a combination, then multivariable, multilevel generalized estimating equation models were used to assess subgroup differences in intervention success, controlling for baseline differences and accounting for clustering by CTN protocols. Results found high correlations among all candidate outcomes. All outcomes showed consistent overall results with no significant intervention impact on drug use during follow-up. However, with most UDS variables, but not with self-report or “corrected self-report,” a significant gender–ethnicity interaction with benefit shown in African American women, White women, and Hispanic men was observed.

Conclusions: Despite strong associations between candidate measures, important differences in results were found. This study demonstrates the potential utility and impact of combining UDS and self-report data for drug use assessment. The results suggest possible differences in intervention efficacy by gender and ethnicity, but highlight the need to cautiously interpret observed interactions. Additional studies like this one will help guide implementation of methodological recommendations to construct combined measures.

Abstract:

THIS PRODUCT IS NO LONGER AVAILABLE. The Motivational Incentives Implementation Software (MIIS) is available at no cost. This platform, developed by the National Institute on Drug Abuse, provides the mechanisms to: assist researchers, clinicians, and counselors in utilizing and applying Motivational Incentives for treating patients with substance use disorders; and maintain information about clinic patients as well as in the implementation and calculation of incentives based on the defined parameters. MIIS is secure, easy to use, and easy to implement. The user interface allows patient information and activities to be stored and can manage patient appointments and supply detailed reports about patient progress. Patients are automatically awarded draws as an incentive for attendance and abstinence. MIIS can be configured to select prizes and provide draws in varying escalation schedules that are sensitive to patient history of compliance and relapse. The software also maintains a record of prizes awarded to patients.

This product has been combined with two other MI Blending Team Products, PAMI and MI:PRESTO to form a “Motivational Incentives (MI) Package.” MIIS has been discontinued; the other two products are available here: https://collaborativeforhealth.org/bettertxoutcomes/.

Related protocols: CTN-0006, CTN-0007