A Feasibility Study for Testing the Effects of Extended-release Naltrexone (Vivitrol) on Recidivism and Other Participant Outcomes in Drug Court Settings
Phase: PHASE4
Conditions: Opioid-Related Disorders
Sponsor: Duke University

AG Robertson, PhD, MPH (PI)        LJAF Criminal Justice RFP - Innovation Tier – Full Proposal 
4/14/16 
 
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A feasibility study for testing the effects of extended-release naltrexone (Vivitrol) on recidivism and other participant 
outcomes in drug court settings 
IMPORTANCE 
Millions of adults with substance use disorders and often co-occurring mental health disorders enter US jails and 
prisons each year.1-3 With insufficient access to treatment and a tradition of criminalizing addiction, people with 
substance use disorders are more likely to be incarcerated than they are to receive the treatment they need.1-5 However, 
there is a growing bipartisan awareness among US policy makers and leaders of behavioral health and criminal justice 
systems that the long trend of over-incarceration has been counterproductive and unsustainably costly.   
Drug treatment courts comprise one of the most promising approaches to diverting offenders with substance use 
disorders away from the justice system, offering offenders with non-violent misdemeanor or felony convictions the 
opportunity to engage in community treatment while under court supervision in lieu of traditional adjudication. Drug 
treatment courts have broadly been conceptualized as a form of “therapeutic jurisprudence”6 because they incorporate 
therapeutic principles into specialized courts to improve criminal justice and clinical outcomes.  Meta-analyses and 
systematic reviews of drug court outcome studies have generally shown that these interventions significantly reduce re-
arrest and incarceration.7-13 Reductions in recidivism average 50% among participants compared to 38% among 
comparison groups receiving typical criminal sentencing. Still, there is room for significant improvement in drug court 
outcomes: approximately 40% of drug court participants drop out of treatment prematurely and only 50% graduate 
from the program.14 Predictors of poor participant outcomes include inadequate length and intensity of treatment,15 low 
treatment motivation,16 and heroin use.16  
One necessary step toward optimizing drug court outcomes is providing participants with access to the best, 
evidence-based treatments available for substance use disorders. Medication-assisted treatment (MAT)—medications 
for treating substance dependence paired with psychosocial treatment—demonstrates strong benefits in achieving 
abstinence and long-term recovery. But it is also a mode of treatment that has been vastly underutilized in justice-
involved populations largely based on ideological objections to a more therapeutic approach and preferences for drug-
free treatment; inadequate knowledge about the benefits of MAT; concerns about misuse and diversion; and lack of 
qualified medical staff to prescribe medications that are frequently unfamiliar to physicians.17, 18 Many drug treatment 
courts have also traditionally banned the use of MAT among their clients, despite its demonstrated evidence base, FDA 
approval, and strong support from national public health leaders.19 Signaling an important shift in collective thinking 
about addiction, and in a specific effort to improve MAT access and implementation, the Office of National Drug Control 
Policy instituted a new policy in April, 2015 requiring all federally-funded drug courts to allow eligible clients to use FDA-
approved medications for the treatment of substance use disorders.  Furthermore, federal funding guidelines encourage 
drug courts to use up to 20 percent of their federal grant dollars to fund MAT for clients.   
Very little is known, however, about the extent to which MAT can help optimize drug court participants’ outcomes 
by reducing recidivism, improving health outcomes, and potentially yielding significant cost savings to the treatment and 
criminal justice systems. A 2010 pilot observational study of extended-release naltrexone (XR-NTX, Vivitrol) for alcohol-
dependent clients in three Michigan and Missouri drug courts demonstrated very promising results, in which the Vivitrol 
group had 57% fewer missed court sessions, a 35% reduction in ratio of positive drug and alcohol tests to total tests, and 
substantial reduction in new arrests (8% with new arrests in Vivitrol group vs. 26% in standard care group).20  
Vivitrol, one of the newest medications for treating both opioid and alcohol dependence, has strong promise for use 
by justice-involved adults with substance use disorders. The once-monthly injection formulation (as compared to the 
daily tablet form) can dramatically improve treatment adherence;21 reduce cravings and block euphoric effects of 
opioids, allowing the individual to focus on other fundamental aspects of their recovery; and because Vivitrol has no 
narcotic properties, there are no concerns about misuse or diversion of this medication. Also, unlike methadone and 
buprenorphine (two other types of MAT), Vivitrol requires no special prescriber licensure, which can otherwise create a 
barrier to access in localities with few qualified providers. A 2016 multi-site randomized controlled trial (RCT) of Vivitrol 
for criminal offenders demonstrated very promising results in a broader population of justice-involved adults, with the 
NCT02978417

AG Robertson, PhD, MPH (PI)        LJAF Criminal Justice RFP - Innovation Tier – Full Proposal 
4/14/16 
 
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Vivitrol arm having significantly lower likelihood of, and time to relapse as compared to the control group.22 The study 
did not detect lower rates of incarceration, though those recidivism data were collected by participant self-report only 
and so were potentially unreliable. The new Vivitrol RCT studied a general population of offenders living in the 
community, who were currently or recently under community correctional supervision (e.g., probation or parole) or had 
been released from jail in the past 12 months. While this is a highly relevant study population, its participants were not 
necessarily engaged in community treatment, nor were they under any type of court leverage to do so; the important 
differences in context preclude generalizing the findings to the drug court setting.      
Vivitrol has especially strong prospects for people who are under legal leverage and court-mandated treatment. 
Most will have detoxified, which is necessary for starting Vivitrol treatment and otherwise very unlikely among actively-
using opioid-dependent individuals in the community; and this highly effective treatment comes at a time when more 
typical reluctance to fully engage in treatment is often outweighed by the individual’s desire to succeed in drug court 
and stay out of jail. The drug court setting offers a unique window of opportunity for a vulnerable population that is 
otherwise difficult to reach and engage in treatment, connecting clients to evidence-based treatment at a time when 
they have the advantages of structure, supervision, and accountability, as well as the support of a multi-disciplinary 
team that aims to help move them into recovery and out of the CJ system. 
A RCT of Vivitrol in drug courts—the criminal justice context that, by design, actively partners with the treatment 
system—would add rigorous evidence about the extent to which it can improve drug court outcomes by reducing 
relapse and recidivism, and thereby improving public safety. In preparation for a Vivitrol-drug court RCT, its feasibility 
must first be assessed to ensure that such a trial would be workable in this complex criminal court setting, including as it 
coordinates with the community treatment system. Feasibility testing will include both addressing special concerns 
around conducting research with this vulnerable, court-involved population, and also assessing study eligibility, interest, 
and retention to insure the next-stage RCT is sufficiently powered for generating conclusive results.  
Building the evidence base for MAT in drug courts could have important, actionable policy implications. The drug 
court setting includes a criminal justice-treatment infrastructure that could support active implementation of Vivitrol 
given its well-defined collaboration with the treatment system and that it is connecting many clients to treatment for a 
first time. This feature of drug courts is distinct from other types of community corrections, which may sometimes link 
individuals under their supervision to treatment, but not as a primary objective. Also, most drug court clients currently 
have very little access to MAT despite its promise for optimizing program outcomes, especially in states that have not 
expanded Medicaid, where the large majority of clients are uninsured and out-of-pocket medication costs are 
prohibitive. Rigorous evidence demonstrating whether MAT helps reduce relapse and recidivism among drug court 
clients would directly inform policy decisions by both drug treatment courts and public behavioral health systems about 
allocating resources to fund MAT for their uninsured clients. Finally, building the conclusive evidence base for the effects 
of Vivitrol on recidivism and other important outcomes for drug court clients would inform drug courts’ policy-making 
around MAT, in particular among courts that use local funds only and continue to have MAT bans in place.   
STUDY DESIGN 
In preparation for a large-scale RCT of Vivitrol effectiveness in drug courts, our team proposes a feasibility study in 
the Wake County, North Carolina drug court, where an estimated 50% of clients are opioid dependent.22 The two 
primary aims of the feasibility study will be to (1) pilot-test the delivery of Vivitrol treatment for 10-20 interested and 
eligible clients of the Wake County drug court; and (2) in parallel with the pilot administration of Vivitrol, study a range 
of feasibility issues for scaling this research to a RCT that would examine court processes, treatment delivery, and 
relevant clinical and justice outcomes, in a study design that provides more definitive results and also addresses  IRB-
related concerns in working with this particularly vulnerable, court-involved  population. 

AG Robertson, PhD, MPH (PI)        LJAF Criminal Justice RFP - Innovation Tier – Full Proposal 
4/14/16 
 
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Table 1. Pilot Vivitrol study
Study measures
BL 
3m 6m 9m  12m
Client characteristicsa
X
# of missed court appointments
X
X
# of positive drug screens
X
X
# of sanctions imposed
X
X
# of new arrests (e.g., violent, non-
violent, drug, felony, misdemeanor)
X
X
# of new incarcerations
X
X
Duration of treatment
X
X
X
X
Client-reported outcomesb
X
X
Schedule of assessments
a E.g., Substance use disorder diagnosis, mental health diagnoses, 
demographics, CJ history
b E.g., Level of functioning, stability, quality of life, employment/ 
education engagement
Aim 1. Pilot Vivitrol study. The 
pilot delivery of Vivitrol in the Wake 
County drug court will be carried out 
with 20-40 eligible drug court clients 
who would be willing and eligible to 
take Vivitrol as part of their existing 
drug court treatment plan, and 
willing to be selected to 
approximately 10-20 Vivitrol slots by 
a lottery process. Eligibility criteria 
will include being aged 18 or older, 
opioid dependent but detoxified, 
having no medical contraindications 
for Vivitrol, not pregnant or 
breastfeeding, and graduation from 
drug court not expected within the 
upcoming 6 months, to allow at least 
6 months to follow study 
participants. Figure 1 depicts the 
conceptual pathway through drug 
court treatment – with and without 
Vivitrol – and the related intermediate and ultimate outcomes of interest, as well as the structure of the proposed study 
around that pathway through treatment for participating court clients. Study participant court outputs and outcomes 
will be measured at varying intervals throughout a 12-month follow-up period (Table 1).  Referral conviction type will be 
recorded, and new arrests (by type) and new incarcerations will be the primary outcomes of interest. New 
incarcerations are recorded and categorized by Fellowship Health Resources, the treatment provider for the drug court, 
as serious (e.g., new criminal offenses) and non-serious (e.g., technical violations of probation like curfew).  
Aim 2. Assess RCT feasibility. The study team will work 
with community and court partners to assess a range of 
feasibility issues for scaling this to a multi-site RCT of Vivitrol 
effectiveness in drug courts. Without pilot data it would be 
difficult to mount such an effectiveness trial because of the 
number of unknown parameters in this unique setting. Key 
areas for generating pilot data include: 1) assessing the impact 
of any potential protocol modifications that might be required 
by the human subjects approval process; 2) assessing the flow 
of eligible patients in one or more courts to inform 
operationalizing a protocol with inclusion/exclusion criteria; 3) 
assessing the variability in number of eligible clients across 
drug courts; 4) estimating dropouts and post-randomization 
exclusions in this population; 5) selecting specific criminal 
justice and clinical outcome measures sensitive to change; and 
6) estimating effect sizes for the primary and secondary outcomes of interest (criminal justice recidivism and clinical 
remission) in this specific population. Figure 2 illustrates the various filters unique to the drug court setting that must be 
estimated to sufficiently power a large-scale RCT. Sufficient data do not currently exist to make stable estimates of 
statistical power and required sample size, the number of study sites needed, and the modification of human subjects 
protocols required to study such a vulnerable population. For these reasons, we propose a pilot study to assess these 
factors in preparation for a more definitive trial. 
 

AG Robertson, PhD, MPH (PI)        LJAF Criminal Justice RFP - Innovation Tier – Full Proposal 
4/14/16 
 
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Step 1 of the feasibility 
assessment will involve 
monitoring and characterizing 
the flow of all drug court 
clients through the program, 
gauging the extent of their 
substance use, interest and 
clinical appropriateness for 
Vivitrol, and insurance status 
(if uninsured, Vivitrol is 
effectively inaccessible due to 
prohibitively high out-of-
pocket cost). These 
assessments will be made by 
reviewing de-identified court 
and treatment records over 
the past 24 months for all drug 
court clients (N=200; 
approximately 90 clients in 
program at any given time), 
and a set of brief client 
interviews about treatment 
experience, including interest 
and experience with Vivitrol or other types of MAT. It will be important to estimate study participant attrition for the 
RCT due to program drop-outs, re-incarcerations, or other factors throughout the steps of these selection processes.  
 
Step 2 of the feasibility assessment will involve identifying training, supervision, and monitoring needs for the RCT, 
in part by tracking the range of tasks performed and coordinated in the pilot-study participants’ utilization of Vivitrol, 
and assessing the extent to which it adheres to the evidence-based model for Vivitrol provision. Fellowship Health 
Resources already provides Vivitrol for some of its agency clients, and so training for them will be minimal at most. For 
judges and other court-involved actors, education about MAT and Vivitrol, in particular, will be important.  Step 2 
assessments will be made via court observation and qualitative interviews with court-involved actors (judges, court 
administrator, probation officers, county prosecutors, public defenders, treatment providers).  
Step 3 will involve developing the full-scale RCT protocol with community partners, including identifying appropriate 
inclusion/exclusion criteria, personnel needs for data collection and record reviews, and reaching agreement on 
appropriate court and treatment access by study personnel. Fellowship staff and the study team will collaborate on joint 
development of the RCT protocol.  We will also build consensus on clinical and functional measures and labs for the RCT, 
and the data collection schedule.  Qualitative interviews and group meetings with the study team and community 
partners will be primary modes of assessment and planning for the development of the RCT protocol.  
Step 4 will involve developing the IRB protocol for a full-scale RCT. We will identify and address special concerns in 
conducting research with this vulnerable, court-involved population, including ensuring there are no elements of 
coercion (real or perceived) for drug court clients introduced by participating in the feasibility study or future RCT while 
under court-mandated treatment, recognizing that the drug court itself, while voluntary, in its own right can be 
perceived as coercive. Potential barriers will be identified and addressed via group meetings and interviews with study 
team and community partners. We will also discuss a set of case vignettes with our community partners to explore 
potential scenarios that could pose a challenge to randomization in this context and a potential threat to the validity of a 
full-scale RCT. It will be critical to evaluate with all stakeholders the promise and feasibility of the next-stage RCT, 
drawing from successful precedents of other types of RCTs conducted in drug court settings and new MAT RCTs in other 
justice-involved populations.13,14,22,24 We will aim to minimize general concerns that arise in randomizing an evidence-

AG Robertson, PhD, MPH (PI)        LJAF Criminal Justice RFP - Innovation Tier – Full Proposal 
4/14/16 
 
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based practice, especially to justice-involved individuals. Duke School of Medicine IRB, Wake County review board, and 
Fellowship Health Resources review board will be consulted for review and oversight of research on human subjects. 
Step 5 will include developing research partnerships with other North Carolina drug courts that support the use of 
MAT, with an objective of engaging 3-5 courts as RCT study sites.  Potential court partners for the RCT that have been 
identified by Wake County drug court administrator Nicole Singletary include Brunswick County (which recently received 
a large federal grant to implement MAT), Guilford, Mecklenburg, and Orange Counties. As part of building potential site 
partnerships and assessing court-specific client flow and eligibility for the RCT, we will conduct court observations at 
each of the courts noted above to understand the extent to which variations in local opioid addiction, and related 
programming resources and referrals will influence client eligibility for the RCT.  Requested study budget: $339,516; 
study duration 2.5 years (30 months). (Please see accompanying budget and justification for details.)  
STUDY TEAM 
Our study team includes a multi-disciplinary group of research and clinical experts to carry out the feasibility study and 
the next-stage RCT. Our team’s expertise includes MAT services, policy, and clinical research, over 20 years of research 
on court-mandated treatment, MAT provision and clinical services, and extensive experience conducting RCTs.  Allison 
Robertson, PhD, MPH (Principal Investigator) is Assistant Professor of Psychiatry and Behavioral Sciences at Duke 
University. Dr. Robertson conducts mental health and substance abuse services research, with a focus on policies, 
programs, and services that address criminal justice involvement in this population. She currently has a NIMH-funded 
career development award (NIMH K0100544) to study the effectiveness and implementation barriers of MAT among 
justice-involved adults with co-occurring mental health and substance use disorders, and a NIDA-funded study (R03-
DA033435) of court-based jail diversion programs. She was also PI on a study funded by the Robert Wood Johnson 
Foundation of court-based jail diversion, in that case examining the effects of short jail stays before being diverted to 
community treatment on program participants’ outcomes. Marvin Swartz, MD, is a Duke psychiatrist, Professor and 
Head of the Psychiatry Department’s Social and Community Psychiatry division, renowned mental health services 
researcher, and Co-PI of the NIMH-landmark Clinical Antipsychotic Trials of Intervention Effectiveness study. Jeffrey 
Swanson, PhD, is Professor of Psychiatry at Duke, and renowned expert in mental health law research. He and Dr. 
Swartz have led multiple studies of court-ordered treatment for adults with severe mental illness, including a large-scale 
RCT in North Carolina.  Drs. Swartz and Swanson were members of the decade-long MacArthur Foundation Research 
Network on Mandated Community Treatment that studied the use of such mandates.  Drs. Swartz, Swanson, and 
Robertson collaborated on a New York State- and MacArthur Foundation-funded longitudinal, statewide evaluation of 
its court-ordered outpatient commitment program, examining program outcomes over eight years.  Those study results 
were widely publicized and have had a direct influence on NY State policymaking on court-mandated treatment.  Drs. 
Swartz, Swanson, and Robertson also conducted a study of the costs of criminal justice involvement among the full adult 
population of public behavioral health clients in Connecticut, in which they monetized a broad range of treatment 
service utilization and criminal justice involvement.  Drs. Swartz’s and Swanson’s extensive expertise in conducting RCTs 
and rich experience studying individuals who are mandated to treatment in a court setting will be a major contribution.  
Paolo Mannelli, MD, Associate Medical Director of Duke Addictions Program and Substance Abuse Consult Liaison 
Program, is an addiction psychiatrist with clinical and research expertise in MAT, including Vivitrol, and extensive 
experience conducting RCTs. Dr. Mannelli has conducted multiple clinical trials of MAT, including a new study of 
combined use of buprenorphine and Vivitrol.  Dr. Mannelli will monitor clinical aspects of the study, including for 
participants taking Vivitrol.  Paul Nagy, MS, LPC, LCAS, CCAS is Assistant Professor in Psychiatry, Training and 
Consultation Director of Duke Addictions Program, a community substance abuse treatment practitioner and consultant, 
and an expert in MAT policy and provision. Mr. Nagy will oversee the study team’s work with Fellowship Health 
Resources in its provision of substance abuse treatment services to drug court clients and advise on related protocol 
development for the RCT. He will also play a central role in developing study site partnerships with drug courts and 
treatment agencies for the next-stage RCT. Michele Easter, PhD, a Senior Research Associate in Duke Psychiatry will 
serve as project manager, coordinating ongoing study activities with community partners, tracking progress toward 
study completion, and assisting with data programming and analysis.  Dr. Easter also collaborated on a series of analyses 
of mandated outpatient treatment in New York City with Duke colleagues, Drs. Swartz, Swanson, and Robertson.  

AG Robertson, PhD, MPH (PI)        LJAF Criminal Justice RFP - Innovation Tier – Full Proposal 
4/14/16 
 
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Our community partners include personnel from the Wake County drug court and staff from Fellowship Health 
Resources, a community-based, private, not-for-profit behavioral health treatment agency that provides a range of 
substance abuse treatment services, including Vivitrol, and contracts with Wake County drug court to provide court 
clients’ treatment.  Fellowship partners include Brandon Robinson, LCAS, LPC, CCS, Director of SA and Corrections 
Services, and Mary Ann Johnson, Region Director. Wake County drug court partners include Nicole Singletary, Drug 
Court Administrator, and presiding Wake County District Court Judges Robert Rader and Judge Craig Croom.  
Letters of support from our two community partner agencies are included in this application. We also include a 
letter of support from Alkermes, the company that manufactures Vivitrol, indicating its commitment to donating 12 
months of medication for 10-20 participants in this feasibility study (with market value of approximately $240,000). 
STRATEGY FOR FOLLOW-UP RCT 
The next-stage RCT will include three to five county-level drug courts in North Carolina, including Wake County drug 
court where the feasibility study will take place.  Three other drug courts in North Carolina that were recommended by 
our Wake County partner, Ms. Singletary, and are enthusiastic about incorporating MAT into their scope of treatment 
include Brunswick County, Guilford County, and Mecklenburg County. With Ms. Singletary as our liaison, we will 
approach each of these courts as leading prospects for partnering in the multi-site RCT.  Other potential partner courts 
for the RCT include Robeson County, which is very enthusiastic about MAT, and Orange and Durham Counties, which 
currently do not allow MAT but are giving it strong consideration.    
At each study site, eligible drug court participants will be randomized to either (1) Vivitrol plus the court-arranged 
treatment plan (e.g., individual and/or group therapy, 12-step meetings), or (2) the court-arranged treatment plan, for a 
12-month course of treatment.  Eligibility criteria will include: being 18 years or older, able to provide informed consent, 
detoxified from opioids, not pregnant or breastfeeding, and no medical contraindications for Vivitrol. Data will be 
collected at baseline, 3 months, 6 months, and 1 year follow-up. Proximal outcomes to be measured will include: 
number of missed court appointments, positive drug screens, and sanctions imposed.  These data will come directly 
from drug court records for each participant. Treatment-related proximal outcome will include number of missed 
treatment appointments, and number of missed Vivitrol treatments for the intervention arm.  Ultimate outcomes of 
interest will include (1) all new arrests, by type (e.g., violent, non-violent, drug, felony, misdemeanor), collected from the 
publicly available North Carolina Automated Criminal Infraction System (ACIS) and drug court records, and new 
convictions, identifying the new arrests that result in a conviction from the drug court records; (2) new incarcerations, 
including categorized as serious or non-serious as described above, collected from drug court and treatment agency 
records; and (3) brief client interviews to yield outcomes related to client preferences regarding treatment, including 
Vivitrol for intervention group; level of functioning and stability; quality of life; and employment/education engagement.    
We will also build a preliminary cost analysis into the RCT, drawing on estimates from the scientific literature, 
including our group’s previous cost research on behavioral health disorders and criminal justice involvement, and where 
possible, administrative budget and expense reports to monetize the key study outcomes (namely, arrest and 
incarceration) and also crisis-driven health care service use (e.g., emergency department visits, hospitalizations) in order 
to estimate the net costs or savings associated with Vivitrol as it relates to changes in recidivism. The methods and 
results from our Connecticut criminal justice cost study will heavily guide the cost work in the next-stage RCT. This cost 
analysis will offer early information about potential cost savings to the justice and healthcare systems to inform a future, 
larger-scale cost-effectiveness analysis if Vivitrol is demonstrated to improve drug court clients’ outcomes in the RCT. 
CONCLUSION 
Drug courts are a unique and successful approach to breaking the link between addiction and criminal justice 
involvement, connecting clients to treatment, often for a first time.  Conclusive evidence is needed to understand the 
extent to which MAT like Vivitrol reduce reoffending among drug court clients.  Building this evidence base is especially 
important now, when federal policy change is building momentum for increased access to MAT in drug courts. Our 
feasibility study will identify and address considerations unique to conducting a Vivitrol RCT in the drug court setting, as 
well as generating preliminary data necessary to power the multi-site RCT. This feasibility study and next-stage RCT will 
produce important, but not yet available evidence that can heavily influence drug court practice and policy on MAT.