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Abstract: This is the Primary Outcomes Article for CTN-0125. Cocaine- and opioid-related overdose deaths have increased among Black people, which makes identifying effective treatments for Black people a high priority. We investigated the comparative effectiveness of behavioral treatments among Black adults who use cocaine and/or opioids. Methods: Identified multisite randomized clinical trials (RCTs) of behavioral interventions that targeted substance use, had participants who self-identified as Black, and included cocaine use outcome measures from the National Drug Abuse Treatment Clinical Trials Network (CTN) datashare. We estimated cocaine use and opioid use severity scale scores while considering study-level measurement non-invariance. Then, we estimated the inverse probability of treatment-weighted (IPTW) linear mixed models to assess comparative effectiveness of treatments that address social-contextual factors and those focused solely on substance use (e.g., contingency management (CM)) relative to treatment-as-usual/controls on cocaine use and opioid use severity scores during- and post-treatment. Results: Nine RCTs met inclusion criteria, with a combined sample of 1,381 Black adults who used cocaine and/or opioids. The IPTW linear mixed models indicated that cocaine use severity decreased from baseline to end-of-treatment across three treatment groups, with a greater decrease for social-contextual treatments and CM relative to treatment-as-usual/controls. However, this greater reduction was maintained at 12-month follow-ups for social-contextual treatments, while CM worsened relative to TAU/controls. We found decreases in latent opioid use severity with no or minor differences between treatment groups. Conclusions: The findings suggest that addressing social-contextual factors is an essential treatment component for long-term reduction of cocaine use among Black adults. Related protocols: CTN-0125

Abstract:

This paper reports on a cost-effectiveness study of protocol CTN-0007, designed to determine if prize-based contingency management (CM), which has been shown to improve treatment outcomes over usual care (UC) alone, is worth the additional cost to treatment agencies. Six methadone maintenance community-based treatment programs (CTPs) in the CTN participated, with a study sample of 388 participants, 190 in the UC condition and 198 in the CM condition (which combined usual care with contingency management).

The authors found that prize-based contingency management provided better patient outcomes than usual care, but required additional costs. Compared to usual care, the incremental cost of using prize-based contingency management to lengthen the longest duration of abstinence (LDA) by one week was $141. The incremental cost to obtain an additional stimulant-negative urine sample was $70. Whether this extra expenditure is worthwhile depends upon the value placed on these outcomes. Using only the benefit of averted crime, an acceptability curve developed by the authors demonstrates a cost-effectiveness benefit of 90%. However, this estimate is quite conservative because averted crime is only one of the many potential benefits of a reduction in substance abuse. By comparing this study to a companion study, the authors also found that adding prize-based contingency management to usual care may be more cost-effective in methadone maintenance clinics than in counseling-based drug-free clinics. Further empirical analyses are needed to help policy makers decide whether CM is worth the extra expense; this paper helps to build an empirical basis for these important decisions.

Related protocols: CTN-0007-A-2

Abstract:

More than half of individuals admitted for specialty substance use disorder treatment in California identify stimulants as their primary or secondary drug, yet many people who use stimulants do not seek treatment. Numerous studies have shown that contingency management (CM) is the most effective treatment for stimulant use disorder. California’s innovative Recovery Incentives Program is a groundbreaking initiative that benefits California and serves as a potential blueprint for other states. In this webinar, Drs. Freese and Urada will delve into the program’s achievements and challenges by providing an overview of the Program, and preliminary quantitative and qualitative evaluation findings. Presenters will talk about the connection to technology and the potential for telehealth implementation in the future. Time will be provided for Q&A and discussion with the audience.

 

Abstract:

Treatments for cannabis use disorder (CUD) have limited efficacy and little is known about who responds to existing treatments. Accurately predicting who will respond to treatment can improve clinical decision-making by allowing clinicians to offer the most appropriate level and type of care. This study aimed to determine whether multivariable/machine learning models can be used to classify CUD treatment responders vs. non-responders.

This secondary analysis used data from National Drug Abuse Treatment Clinical Trials Network (NIDA CTN) multi-site outpatient clinical trial (CTN-0053, Achieving Cannabis Cessation – Evaluating N-Acetylcysteine Treatment (ACCENT)). Adults with CUD (N=302) received 12 weeks of contingency management, brief cessation counseling, and were randomized to receive additionally either 1) N-Acetylcysteine or 2) placebo. Multivariable/machine learning models were used to classify treatment responders (i.e., two consecutive negative urine cannabinoid tests or a 50% reduction in days of use) versus non-responders using baseline demographic, medical, psychiatric, and substance use information.

Prediction performance for various machine learning and regression prediction models yielded area under the curves (AUCs) greater than 0.70 for four models (0.72-0.77), with support vector machine models having the highest overall accuracy (73%; 95% confidence interval [CI]: 68-78%) and AUC (0.77; 95% CI: 0.72, 0.83). Fourteen variables were retained in at least 3 of 4 top models, including demographic (ethnicity, education), medical (diastolic/systolic blood pressure, overall health, neurological diagnosis), psychiatric (depressive symptoms, generalized anxiety disorder, antisocial personality disorder), and substance use (tobacco smoker, baseline cannabinoid level, amphetamine use, age of experimentation with other substances, cannabis withdrawal intensity) characteristics.

Conclusions: Multivariable/machine learning models can improve upon chance prediction of treatment response to outpatient cannabis use disorder treatment, though further improvements in prediction performance are likely necessary for decisions about clinical care.

Related protocols: CTN-0053

Abstract:

Engaging people living with HIV who report substance use (PLWH-SU) in care is essential to HIV medical management and prevention of new HIV infections. Factors associated with poor engagement in HIV care include a combination of syndemic psychosocial factors, mental and physical comorbidities, and structural barriers to healthcare utilization. Patient navigation (PN) is designed to reduce barriers to care, but its effectiveness among PLWH-SU remains unclear. In this study, researchers analyzed data from NIDA Clinical Trials Network protocol CTN-0049, a three-arm randomized controlled trial testing the effect of a 6-month PN with and without contingency management (CM), on engagement in HIV care and viral suppression among PLWH-SU (n=801). Latent profile analysis was used to identify subgroups of individuals’ experiences to 23 barriers to care. The effects of PN on engagement in care and viral suppression were compared across latent profiles. Three latent profiles of barriers to care were identified. The results revealed that PN interventions are likely to be most effective for PLWH-SU with fewer, less severe healthcare barriers. Special attention should be given to individuals with a history of abuse, intimate partner violence, and discrimination, as they may be less likely to benefit from PN alone and require additional interventions.

Related protocols: CTN-0049

Abstract:

Patient engagement may play a key role in the success or failure of treatments for substance use disorder (SUD). This exploratory analysis of data from a large, multisite effectiveness trial (CTN-0044) sought to determine how patient engagement with a digital therapeutic for SUD delivered at clinics was associated with abstinence outcomes.

The study evaluated engagement for 206 participants enrolled in a treatment program for SUDs related to cocaine, alcohol, cannabis, or other stimulants who were randomized to receive treatment as usual (TAU) or reduced TAU plus the digital Therapeutic Education System (TES) for 12 weeks. Participants were eligible for contingency management incentives for module completion (modules cover Community Reinforcement Approach topic areas) and negative urine drug screens. Analyses examined the association of module completion with end-of-treatment abstinence.

Participants completed a mean of 38.8 (range 0–72) TES modules over 12 weeks of treatment. Study completers (n = 157) completed a mean of 45.5 (range 9–72) TES modules, whereas study noncompleters (n = 49) completed a mean of 17.4 (range 0–45) TES modules. The study observed a strong positive correlation between TES engagement (i.e., total number of modules completed) and the probability of abstinence during weeks 9–12 of treatment among 157 study completers. Each module completed increased the odds of abstinence during weeks 9–12 by approximately 11% for study completers and 9% for the full sample. The study observed a similar, but weaker, association between engagement and abstinence among 49 patients who did not complete the study.

Conclusions: Greater engagement with a digital therapeutic for patients with SUD (i.e., number of modules completed over time) was strongly associated with the probability of abstinence in the last four weeks of treatment among those who completed the recommended 12-week treatment.

Related protocols: CTN-0044

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:

People living with HIV who report substance use (PLWH-SU) face many barriers to care, resulting in an increased risk for poor health outcomes and the potential for ongoing disease transmission. This study evaluates the mechanisms by which patient navigation (PN) and contingency management (CM) interventions may work to address barriers to cae and improve HIV outcomes in this population.

Mediation analysis was conducted using data from CTN-0049 (Project HOPE), a randomized, multi-site trial testing PN interventions to improve HIV care outcomes among 801 hospitalized PLHW-SU. Direct and indirect effects of PN and PN+CM were evaluated through five potential mediators (psychosocial conditions, healthcare avoidance, financial hardship, system barriers, and self-efficacy for HIV treatment adherence) on engagement in HIV care and viral suppression.

The PN+CM intervention had an indirect effect on improving engagement in HIV care at 6 months by increasing self-efficacy for HIV treatment adherence. PN+CM also led to increases in viral suppression at 6 months via increases in self-efficacy, although the direct effects were not significant. No mediating effects were observed for PN alone.

Conclusions: PN+CM interventions for PLWH-SU can increase an individual’s self-efficacy for HIV treatment adherence, which in turn improves engagement in care at 6 months and may contribute to viral suppression over 12 months. Building self-efficacy may be a key factor in the success of such interventions and should be considered as a primary goal of PN+CM in practice.

Related protocols: CTN-0049, CTN-0049-A-1

Abstract:

Depression is common among individuals with cannabis use disorder (CUD), particularly those who present for CUD treatment. Treatments that consider this comorbidity are essential.

The goal of this secondary analysis was to examine whether N-acetylcysteine (NAC) reduced depressive symptoms among adults (age 8-50) with CUD (N=302) and whether the effect of NAC on cannabis cessation varied as a result of baseline levels of depression. Bidirectional associations between cannabis use amount and depression were also examined.

Data for the analysis were from a NIDA Clinical Trials Network multi-site clinical trial for CUD (CTN-0053). Adults with CUD (N=302) were randomized to receive 2400mg of NAC daily or matched placebo for 12 weeks. All participants received abstinence-based contingency management. Cannabis quantity was measured by self-report, and weekly urinary cannabinoid levels (11-nor-9-carboxy- 9-tetrahydrocannabinol) confirmed abstinence. Depressive symptoms were measured by the Hospital Anxiety and Depression Scale.

Results found that depressive symptoms did not differ between the NAC and placebo groups during treatment. There was no significant interaction between treatment and baseline depression predicting cannabis abstinence during treatment. Higher baseline depression was associated with decreased abstinence throughout treatment and a significant gender interaction suggested that they may be particularly true for females. Cross-lagged panel models suggested that depressive symptoms preceded increased cannabis use amounts (in grams) during the subsequent month. The reverse pathway was not significant (i.e., greater cannabis use preceding depressive symptoms).

Conclusions: Results from this study indicate that symptoms of depression may be a barrier to cannabis cessation among adults, regardless of whether NAC is administered. Overall, the findings suggest that depressive symptoms should be considered clinically relevant within cannabis cessation programs for adults, and that more research is needed to explore treatments that could mitigate the impact of depressive symptoms on treatment outcomes. Treatments that address depressive symptoms concurrently with CUD treatment may be particularly beneficial.

Related protocols: CTN-0053

Abstract:

Presented to the CTN Steering Committee, this webinar offers a 40 year retrospective of Dr. Stitzer’s career in addiction research. Includes the following sections:

• Part 1: Opioid physical dependence
• Part 2: Opioid treatment medication studies
• Part 3: Contingency management (CM)
• Part 4: Future directions summary

Download slides.

Abstract:

The Community Reinforcement Approach (CRA) is an evidence-based practice for the treatment of substance use disorders (SUDs) and achieving and maintaining abstinence, but few studies have systematically explored the effect of CRA on secondary, yet also important, outcomes, such as social functioning.

This study was a secondary data analysis of CTN-0044, “Web Delivery of Evidence-Based, Psychosocial Treatment for Substance Use Disorders.” The purpose was to examine whether an internet-based version of CRA plus contingency management (Therapeutic Education System, TES) is associated with improved social functioning of individuals seeking substance use disorder treatment in a multi-site clinical effectiveness trial.

Social functioning was measured using the 54-item Social Adjustment Scale (SAS) assessing role performance in six domains (work, social and leisure activities, extended family relationships, marital relationship, parenting, and immediate family). Generalized linear mixed models tested the effects of treatment, time, sex, baseline abstinence, baseline social functioning and baseline psychological distress on overall social functioning and across social functioning subscales at the end of the 12-week treatment phase and three and six months post treatment.

Results showed no significant association between treatment and total social functioning score or any subscale scores. Being male, however, was significantly associated with better social functioning overall at the end of treatment (p=.024). Additionally, higher levels of psychological distress at baseline predicted significantly worse social functioning at the end of treatment overall (p=.037).

Conclusions: While TES was not associated with improvement in social functioning outcomes among participants when compared to TAU, male participants and those with less psychological distress at baseline experienced greater improvements in social functioning at the end of treatment. When integrating TES into community treatment programs, it may be important to have counselors involved to guide clients when choosing modules; completing home practice is also a critical factor in improving outcomes and should be monitored. In addition, improved measures of social functioning may be needed for studies involving patients with substance use disorders as more traditional secondary outcomes, such as social functioning and quality of life, should be more systematically studied in research involving treatment for substance use disorders.

Related protocols: CTN-0044

Abstract:

While patient navigation has been shown to be an effective approach for linking persons to HIV care, and contingency management is effective at improving substance use-related outcomes, Project HOPE combined these two interventions in a novel way to engage HIV-positive patients with HIV and substance use treatment.

The aims of this paper are to examine patient navigator views regarding how contingency management interacted with and affected their navigation process. Individual, semi-structured interviews lasting approximately 60 minutes were administered to 22 patient navigators from the original 10 Project HOPE study sites. The interviews address the patient navigator’s professional background, descriptions of the participant population, substance use disorder vs. HIV treatment entry and engagement issues, and the use of contingency management within the navigation service delivery protocol.

Patient navigators believed that financial incentives helped motivate participant attendance at navigation sessions, particularly early in study involvement, which helped them to establish rapport and develop relationships with participants. Patient navigators often noted that financial incentives positively influenced targeted HIV health-related behaviors, such as attending medical appointments, which provided a rapid pay-off with an escalating sum. Contingency management was more complex when used by the patient navigators for substance use-related behaviors, particularly when incentives revolved around negative urine screening. Patient navigators noted that not all participants responded the same way to the contingency management and that the incentives were particularly helpful when participants were financially strained with limited resources or when internal motivation was lacking.

Conclusions: Overall, patient navigators found the inclusion of contingency management to be helpful and effective at influencing participant behaviors, particularly concerning navigation session attendance and HIV healthcare-related participation. However, issues and concerns surrounding the inclusion of contingency management for drug-related behaviors as delivered in Project HOPE were noted.

Related protocols: CTN-0049

Abstract:

This secondary analysis of data from Clinical Trials Network protocol CTN-0049, Project HOPE, compares outcomes for two groups of HIV+ substance users randomized in a 3-arm trial to receive Patient Navigation with (PN+CM) or without (PN) contingent financial incentives (CM). Mean age of participants was 45 years; the majority was male (67%), African American (78%), unemployed (35%), or disabled (50%). Behaviors incentivized for PN+CM were (1) attendance at HIV care visits and (2) verification of an active HIV medication prescription.

Incentives were associated with shorter time to treatment initiation and higher rates of behaviors during the 6-month intervention with exception of month 6 HIV care visits. Median HIV care visits were 3 (IQR 2–4) for PN+CM versus 1.5 (IQR 0–3) for PN (Wilcoxon p < 0.001); median validated medication checks were 4 (IQR 2–6) for PN+CM versus 1 (IQR 0–3) for PN (Wilcoxon p < 0.001). Viral suppression rates at end of treatment were not significantly different for the two groups but were directly related to the number of behaviors completed for both care visits and validated medication.

Conclusions: Contingent financial incentives added to a PN intervention were associated with better engagement in the navigation intervention, including earlier initiation and higher sustained rates of key health-related behaviors deemed necessary to achieve a final goal of viral load suppression. In addition to higher rates of initiation, it was notable that incentives were associated with a shorter average time both to the initial HIV care visit and to first verified pick up of HIV medication among those who ever initiated these behaviors. These robust results suggest value of incentives as a tool to enhance linkage to care, as well as speeding up or “kick starting” early steps in the care process within a navigation intervention. Adjustments to the incentive program may be needed to achieve greater rates of sustained health behavior change that result in improved viral load outcomes.

Related protocols: CTN-0049, CTN-0049-A-1

Abstract:

The Therapeutic Education System (TES), an Internet version of the Community Reinforcement Approach plus prize-based motivational incentives, is one of few empirically supported technology-based interventions. To date, however, there has not been a study exploring differences in substance use outcomes or acceptability of TES among racial/ethnic subgroups. This study uses data from a multisite (N=10) effectiveness study of TES to explore whether race/ethnicity subgroups (White [n=267], Black/African American [n=112], and Hispanic/Latino [n=55]) moderate the effect of TES. Generalized linear mixed models were used to test whether abstinence, retention, social functioning, coping, craving, or acceptability differed by racial/ethnic subgroup. Findings demonstrated that race/ethnicity did not moderate the effect of TES versus TAU on abstinence, retention, social functioning, or craving. A three-way interaction (treatment, race/ethnicity, and abstinence status at study entry) showed that TES was associated with greater coping scores among non-abstinent White participants (p=.008) and among abstinent Black participants (p<.001). Acceptability of the TES intervention, although high overall, was significantly different by race/ethnicity subgroup with white participants reporting lower acceptability of TES compared to Black (p=.006) and Hispanic/Latino (p=.008) participants.

Conclusions: Findings from this study lend additional support for the use of technology-based interventions in the treatment of substance use disorders. The acceptability of Internet-delivered interventions among racial/ethnic minority populations suggests promise for increasing access to services and reducing disparities in treatment outcomes. In this large multisite national study, racial/ethnic subgroups received similar benefit from Internet-based CRA/CM and reported high rates of acceptability, with Black participants reporting the highest rates of acceptability. TES should be considered as an additional tool to support usual care in outpatient treatment programs among diverse subgroups of patients.

Related protocols: CTN-0044

Abstract:

Interventions are needed to improve viral suppression rates among persons with HIV and substance use. A 3-arm randomized multi-site study (CTN-0049, Project HOPE) was conducted to evaluate the effect on HIV outcomes of usual care referral to HIV and substance use services (N=253) versus patient navigation delivered alone (PN: N=266) or together with contingency management (PN+CM: N=271) that provided financial incentives targeting potential behavioral mediators of viral load suppression. This secondary analysis evaluates the effects of financial incentives on attendance at PN sessions and the relationship between session attendance and viral load suppression at the end of the intervention.

Frequency of sessions attended was analyzed over time and by distribution of individual session attendance frequency (PN vs PN+CM). Percent virally suppressed (<200 copies/mL) at 6 months was compared for low, medium, and high rate attenders. In PN+CM a total of $220 could be earned for attendance at 11 PN sessions over the 6-month intervention with payments ranging from $10 to $30 under an escalating schedule.

The majority (74%) of PN-only participants attended 6 or more sessions but only 28% attended 10 or more and 16% attended all eleven sessions. In contrast, 90% of PN+CM attended 6 or more visits, 69% attended 10 or more, and 57% attended all eleven. Overall (PN and PN+CM participants combined) percent with viral load suppression at 6-months was 15, 38, and 54% among those who attended 0-5, 6-9, and 10-11 visits, respectively.

Conclusion: In this secondary post hoc analysis, contact with patient negotiators was increased by attendance incentives. Higher rates of attendance at patient navigation sessions was associated with viral suppression at the 6-month follow-up assessment. Study results support use of attendance incentives to improve rates of contact between service providers and patients, particularly patients who are difficult to engage in care.

Related protocols: CTN-0049