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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

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

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

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

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

Although counseling is a required part of office-based buprenorphine treatment of opioid use disorders, the nature of what constitutes appropriate counseling is unclear and controversial. This paper is a review of the literature on the role, nature, and intensity of behavioral interventions in office-based buprenorphine treatment, including the NIDA Clinical Trials Network’s Prescription Opiate Abuse Treatment Study (POATS, CTN-0030; this paper received support from the New England Consortium Node’s CTN grant). The authors conducted a review of randomized controlled studies testing the efficacy of adding a behavioral intervention to buprenorphine maintenance treatment.

Four key studies showed no benefit from adding a behavioral intervention to buprenorphine plus medical management, and found studies indicated some benefit for specific behavioral interventions, primarily contingency management. The authors examined the findings from the negative trials in the context of six questions: 1) Is buprenorphine that effective? 2) Is medical management that effective? 3) Are behavioral interventions that ineffective in this population? 4) How has research design affected the results of studies of buprenorphine plus behavioral treatment? 5) What do we know about subgroups of patients who do and those who do not seem to benefit from behavioral interventions? 6) What should clinicians aim for in terms of treatment outcome in buprenorphine maintenance?

Conclusions: High-quality medical management may suffice for some patients, but there are few data regarding the types of individuals for whom medical management is sufficient. Physicians should consider a stepped-care model in which patients may begin with relatively nonintensive treatment, with increased intensity for patients who struggle early in treatment. Finally, with 6-month retention rates seldom exceeding 50% and poor outcomes following dropout, we must explore innovative strategies for enhancing retention in buprenorphine treatment.

Related protocols: CTN-0030

Contingency management (CM) interventions generally target a single behavior such as attendance or drug use. However, disease outcomes are mediated by complex chains of both healthy and interfering behaviors enacted over extended periods of time. This paper describes a novel multi-target contingency management (CM) program developed for use with HIV positive substance users enrolled in a CTN multi-site study (CTN-0049, Project HOPE). Participants were randomly assigned to usual care (referral to health care and SUD treatment) or 6-months strength-based patient navigation interventions with (PN+CM) or without (PN only) the CM program. Primary outcome of the trial was viral load suppression at 12-months post-randomization. Up to $1160 could be earned over 6 months under escalating schedules of reinforcement. Earnings were divided among eight CM targets: two PN-related (PN visits, paperwork completion; 26% of possible earnings), four health-related (HIV care visits, lab blood draw visits, medication check, viral load suppression; 47% of possible earnings), and two drug-use abatement (treatment entry, submission of drug negative UAs; 27% of earnings).

This paper describes the rationale for selection of targets, pay amounts, and pay schedules. The CM program was compatible with and fully integrated into the PN intervention. The Project HOPE CM program offers one example of how a multi-target CM intervention might be structured and deployed to impact a critical outcome in a difficult to treat population (in this case, HIV positive substance users). Subsequent data analysis examining the impact of the CM intervention on behavior frequencies will inform the structure and content of future multi-target CM interventions, while considerations of sustainability and cost-effectiveness will be needed to inform implementation policy.

Related protocols: CTN-0049

This study aimed to examine prize-earning costs of contingency management (CM) incentives in relation to participants’ pre-study enrollment drug use status (baseline (BL) positive vs. BL negative) and relate these to previously reported patterns of intervention effectiveness. Participants were 255 substance users entering outpatient treatment who received the therapeutic education system (TES) in addiction to usual care counseling (as part of NIDA Clinical Trials Network protocol CTN-0044). TES included a CM component such that participants could earn up to $600 in prizes on average over 12-weeks for providing drug negative urines and completing web-based cognitive behavior therapy modules. This secondary analysis examined distribution of prize draws and value of prizes earned for subgroups that were abstinent (BL negative; N=136) or not (BL positive; N=119) at study entry based on urine toxicology and breath alcohol screen.

Results found that distribution of draws earned (median=119 vs. 17; p < .0001) and prizes redeemed (median=54 vs. 9; p < .001) for drug abstinence differed significantly for BL negative compared to BL positive participants. BL negative earned on average twice as much in prizes as BL positive participants ($245 vs. $125). Median value of prizes earned was 5.4 times greater for BL negative compared to BL positive participants ($237 vs. $44; p<.001).

Conclusions: Two-thirds of expenditures in an abstinence incentive program were paid to BL negative participants. These individuals had high rates of drug abstinence during treatment and did not show improve abstinence outcomes with TES versus usual care. Effectiveness of the abstinence-focused CM intervention in TES may be enhanced by tailoring delivery based on patients’ drug use status at treatment entry.

Related protocols: CTN-0044

Coping strategies are a predictor of abstinence among patients with substance use disorders (SUD). However, little is known regarding the role of coping strategies in the effectiveness of the Community Reinforcement Approach (CRA). Using data from a 12-week randomized control trial assessing the effectiveness of the Therapeutic Education System (TES), an internet-delivered version of the CRA combined with contingency management, this study tested the role of coping strategies as a mediator of treatment effectiveness. 507 participants entering 10 outpatient addiction treatment programs received either treatment-as-usual (TAU), a counselor-delivered treatment (Arm 1), or reduced TAU plus TES wherein 2 hours of TAU per week were replaced by TES (Arm 2). Abstinence from drugs and alcohol was evaluated using urine toxicology and self-report. Coping strategies were measured using the Coping Strategies Scale-Brief Version. Mediation analyses were done following Baron and Kenny’s and path analysis approaches.

The average baseline coping strategies were not significantly different between the two treatment arms. Overall, TES intervention was significantly associated with higher coping strategies scores when accounting for baseline scores. Additionally, higher coping strategies scores at week 12 were associated with an increased likelihood of abstinence during the last 4 weeks of the treatment, while accounting for treatment assignment and baseline abstinence. The effect of TES intervention on abstinence was no longer significant after controlling for coping strategies scores at week 12.

Conclusions: Results of this analysis support the importance of coping skills as a partial mediator of the effectiveness of an internet-version of the CRA combined with contingency management. CRA is an efficacious behavioral approach but implementation is limited, often due to the resources required for proper training and delivery. Thus, this study supports the promising role of internet-assisted therapeutic approaches for substance use disorders and, most importantly, it provides additional evidence of the role of coping strategies as a mechanism of effective SUD treatment.

Related protocols: CTN-0044

The acceptability and clinical impact of a web-based intervention among patients entering addiction treatment who lack recent internet access are unclear. This secondary analysis of a national multisite treatment study (CTN-0044) assessed for acceptability and clinical impact of a web-based psychosocial intervention among participants enrolling in community-based, outpatient addiction treatment programs. Participants were randomly assigned to 12 weeks of a web-based therapeutic education system (TES) based on the community reinforcement approach plus contingency management versus treatment as usual (TAU).

Demographic and clinical characteristics and treatment outcomes were compared among participants with recent internet access in the 90 days preceding enrollment (N=374) and without internet access (N=133). Primary outcome variables included (1) acceptability of TES (i.e., module completion, acceptability of web-based intervention) and (2) clinical impact (i.e., self-reported abstinence confirmed by urine drug/breath alcohol tests, retention measured as time to dropout).

Internet use was common (74%) and was more likely among younger (18-49 year old) participants and those who completed high school (p<.001). Participants randomized to TES (n=255) without baseline internet access rated the acceptability of TES modules significantly higher than those with internet access (t=2.49, df=218, p=.01). There was a near significant interaction between treatment, baseline abstinence, and internet access on time to dropout. TES was associated with better retention among participants not abstinent at baseline who had internet access.

Conclusions: This study explores the association between internet access and demographic and clinical outcomes among a national multi-site sample of patients entering community-based, outpatient addiction treatment. Overall, the data are encouraging for the potential to use technology-based interventions among diverse outpatient addiction treatment populations. Rates of internet access (in the 90 days prior to enrollment) (74%) were similar to the general population (79%). Further, there was high acceptability of the web-based intervention, especially among participants reporting no recent internet access. Findings also suggest that a lack of recent internet access was not associated with abstinence or retention outcomes. Expanding the capacity of publicly funded community-based addiction treatment programs with acceptable evidence-based health information technologies is imperative. The suitability of providing access and training to web-based interventions within clinics may mitigate barriers to access among vulnerable populations lacking remote internet access.

Related protocols: CTN-0044

This is the primary outcomes article for CTN-0049.

Substance use is a major driver of the HIV epidemic and is associated with poor HIV care outcomes. Patient navigation (care coordination with case management) and the use of financial incentives for achieving predetermined outcomes are interventions increasingly promoted to engage patients in substance use disorders treatment and HIV care, but there is little evidence for their efficacy in improving HIV-1 viral suppression rates. This study aimed to assess the effect of a structured patient navigation intervention with or without financial incentives to improve HIV-1 viral suppression rates among patients with elevated HIV-1 viral loads and substance use recruited as hospital inpatients.

From July 2012 – January 2014, 801 patients with HIV infection and substance use from 11 hospitals across the United States were randomly assigned to receive patient navigation alone (n=266), patient navigation plus financial incentives (n=271), or treatment as usual (n=264). HIV-1 plasma viral load was measured at baseline and at 6 and 12 months. Patient navigation included up to 11 sessions of care coordination with case management and motivational interviewing techniques over 6 months. Financial incentives (up to $1160) were provided for achieving targeted behaviors aimed at reducing substance use, increasing engagement in HIV care, and improving HIV outcomes. Treatment as usual was the standard practice at each hospital for linking hospitalized patients to outpatient HIV care and substance use disorders treatment. The primary outcome was HIV viral suppression (less than or equal to 200 copies/mL) relative to viral nonsuppression or death at the 12-month follow-up.

Of 801 patients randomized, 261 (32.6%) were women (mean [SD] age, 44.6 years [10 years]). There were no differences in rates of HIV viral suppression versus nonsuppression or death among the 3 groups at 12 months. Eighty-five of 249 patients (34.1%) in the usual-treatment group experienced treatment success compared with 89 of 249 patients (35.7%) in the navigation-only group, for a treatment difference of 1.6%, and compared with 98 of 254 patients (38.6%) in the navigation-plus-incentives group, for a treatment difference of 4.5%. The treatment difference between the navigation-only and navigation-plus-incentives group was -2.8%.

Conclusions: Among hospitalized patients with HIV infection and substance use, patient navigation with or without financial incentives did not have a beneficial effect on HIV viral suppression relative to nonsuppression or death at 12 months vs. treatment as usual. These findings do not support these interventions in this setting and indicate that other approaches are needed to improve HIV outcomes in this vulnerable population.

Related protocols: CTN-0049

The National Drug Abuse Treatment Clinical Trials Network WEB-TX study is one of the largest randomized controlled trials to date examining the effectiveness of an internet-delivered treatment intervention on clinical outcomes among people receiving outpatient substance abuse treatment.

In addition to the primary outcome analysis showing significant improvements in abstinence and treatment retention among people randomized to the internet-delivered treatment arm, the study has produced three methodological publications, four baseline publications, five secondary outcome publications, and an additional seven secondary outcome publications under review or in preparation.

The purpose of this one-hour webinar, presented by Edward Nunes, MD and Aimee Cambell, PhD, was to present a synthesis of WEB-TX study findings focusing on key secondary clinical outcomes and discuss new areas of research for technology-based treatments for substance use disorders.

Additional Resources:

• Download slides (pdf)
• Download handout (pdf)
• List of publications(pdf)

Related protocols: CTN-0044

Substance misuse and excessive alcohol consumption are major public health issues. Internet-based interventions for substance use disorders (SUDs) are a relatively new method for addressing barriers to access and supplementing existing care. This study examines cost-effectiveness in a multisite, randomized trial of an Internet-based version of the community reinforcement approach (CRA) with contingency management (CM) known as the Therapeutic Education System (TES) (CTN protocol 0044, “Web Delivery of Evidence-Based, Psychosocial Treatment for Substance Use Disorders”). The study involved an economic evaluation of the 12-week trial with follow-up at 24 and 36 weeks. 507 individuals who were seeking therapy for alcohol or other substance use disorders at 10 outpatient community-based treatment programs were recruited and randomized to either treatment as usual (TAU) or TES+TAU. Sub-analyses were completed on participants with a poorer prognosis (i.e., those not abstinent at study entry).

Results found that, from the provider’s perspective, TES+TAU as it was implemented in this study costs $278 (SE=87) more than TAU alone after 12 weeks. The quality-adjusted life years gained by TES+TAU and TAU were similar; however, TES+TAU participants remained in treatment longer and achieved more days of abstinence than TAU patients. Regarding clinical outcome of abstinent years, TES+TAU qualifies as cost-effective with a level of confidence exceeding 95% for willingness-to-pay values above $20,000. That is, if the stakeholder is willing to pay $20,000 per abstinent-year, it is 95% likely they will find TES+TAU to be a “good value.” In general, findings were more promising for participants who were not abstinent at study entry.

Conclusions: With regard to the clinical outcome of abstinence, our cost-effectiveness findings of TES+TAU compare favorably to those found elsewhere in the CM literature. Moreover, depending on providers’ and payers’ thresholds for defining value with regard to abstinence, TES+TAU has a high likelihood of being considered a wise investment. The analyses performed here serve as an initial economic framework for future studies integrating technology into SUD therapy.

Related protocols: CTN-0044

Despite strong support for its efficacy, debates persist about how dissemination of contingency management is most effectively undertaken. Currently-promoted contingency management methods are empirically-validated, yet their congruence with interests and preferences of addiction treatment clientele is unknown. Such client input is a foundational support for evidence-based practice. This study documented interest in incentives and preferences for fixed-ratio vs. variable-ratio and immediate vs. distal distribution of earned incentives among clients enrolled at three community programs affiliated with the National Institute on Drug Abuse Clinical Trials Network.

This multi-site CTN platform study included anonymous survey completion by an aggregate sample of 358 treatment enrollees. Analyses first ruled out site differences in survey responses, and then tested age and gender as influences on client interest in financial incentives, and preferences for fixed-ratio vs. variable-ratio reinforcement and immediate vs. distal incentive distribution. Results found that interest in different types of $50 incentives (i.e. retail vouchers, transportation vouchers, cash) was highly inter-correlated, with a mean sample rating of 3.49 (0.83) on a five-point scale. While consistent across client gender, age was an inverse predictor of client interest in incentives, with youth exhibiting more interest in incentives). A majority of clients stated preference for fixed-ratio incentive magnitude and distal incentive distribution (67% and 63%, respectively), with these preferences voiced by a larger proportion of females.

Conclusions: This study offered a helpful glimpse into client perspectives about design features of contingency management interventions, and found that those preferences contradicted currently-promoted contingency management design features. Future efforts to disseminate contingency management may be more successful if flexibly undertaken in a manner that incorporates the interests and preferences of local client populations.

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