Co-Use of Opioid Medications and Alcohol Prevention Study (COAPS)
Phase: NA
Conditions: Alcohol Drinking, Opioid Use
Sponsor: University of Utah

 
 
 
 
 
 
 
 
Study Title: COAPS: Co-Use of Opioid Medications and Alcohol Prevention Study 
NCT: 05599672 
Document Date: Version 1.0 March 11, 2022; IRB approval: April 13, 2022 

Version 1.0; 11Mar2022 
PI: Jerry Cochran, PhD 
 
Co-Use of Opioid Medications and Alcohol Prevention Study (COAPS)  
 
SPECIFIC AIMS 
Co-use of alcohol and opioid medications can result in serious individual harm. Given alcohol and opioids 
act on μ-opioid receptors,1 coinciding consumption potentiates their analgesic effects—producing severe respir-
atory depression, sedation2-6 and heightened overdose risk.7,8 Co-use of alcohol and opioids persists in the US 
notwithstanding these serious health/safety hazards. Although limited information is available within peer-re-
viewed literature,9 large-scale system and clinical research have demonstrated 24-38% of those with alcohol use 
disorders also have an opioid use disorder,10,11 with rates of past 30 day opioid medication misuse among those 
seeking alcohol treatment as high as 68%.12 Also, half of those with binge alcohol use have past 30 day opioid 
medication misuse.13 Our 3 recent studies in community pharmacies with patients receiving opioid medications 
provide further insight into co-use of alcohol and opioids. Community pharmacy is rapidly becoming recognized 
as a valuable setting to address opioid medication-related risk14 given a multi-decade shift with pharmacists 
integrated into team-based care leading medication management.15-22 In our first study, we screened 344 phar-
macy patients receiving opioid prescriptions in 4 pharmacies (71% consent rate)—22.4% reported current risk 
drinking.23 Our second study was a small-scale-clinical trial testing the Brief Intervention-Medication Therapy 
Management (BI-MTM) intervention among pharmacy patients with opioid medication misuse in 2 community 
pharmacies (N=32; 74% consent rate). BI-MTM showed significant improvements for mitigating opioid medica-
tion misuse, depression, and pain compared to control patients (Standard Medication Counseling [SMC]).24 In 
this study—19% of participants reported current risk drinking at enrollment.24 Finally, our third, recently com-
pleted study, screened patients in 19 community pharmacies at point-of-opioid-dispensing (94% consent rate).25 
Of the 1,523 patients screened—31% reported current risk drinking.26 Given these patterns of co-use of alcohol 
and opioids medications—particularly in community pharmacy—we propose to adapt, manualize, and test the 
acceptability, feasibility, and preliminary efficacy of an Alcohol-targeted Brief Intervention-Medication Therapy 
Management (ABI-MTM) intervention with community pharmacy patients. ABI-MTM will be a pharmacy-based 
medication management intervention27 combined with Screening, Brief Intervention, and Referral to Treatment28-
31 delivered as 1 session at point-of-dispensing with a 7-day telephone-based booster session. ABI-MTM will 
target: (1) alcohol use elimination during opioid treatment OR (2) non-opioid pain management substitution (in 
consultation with the prescriber). This study will accomplish 3 Specific Aims (SA): 
SA1: Adapt/manualize an Alcohol-targeted Brief Intervention-Medication Therapy Management 
intervention. Rationale: BI-MTM was developed to address opioid medication misuse and comorbid health con-
ditions (e.g., pain, mental health); yet, it was not designed for universal delivery to patients with active opioid 
prescriptions and concurrent alcohol use. Approach: We will utilize the ADAPT-ITT (Assessment, Decision, Ad-
ministration, Production, Topical Experts, Integration, Training, and Testing)32 framework to modify/manualize 
BI-MTM for delivery to community pharmacy patients with co-use of alcohol (both risk level and non-risk level 
alcohol use) and opioid medications (i.e., an Alcohol-targeted Brief Intervention-Medication Therapy Manage-
ment or ABI-MTM). Outcome: Completion of SA1 will result in a manualized protocol for clinical trial evaluation.  
SA2: Test the Feasibility, Acceptability, and Preliminary Efficacy of ABI-MTM for Community Phar-
macy Patients with Concomitant Alcohol and Opioid Medication Use. Rationale: The extent to which ABI-
MTM: is acceptable to patients, can be feasibly delivered in community pharmacy settings, and can mitigate co-
use of alcohol and opioid medications is unknown. Approach: We will conduct a small-scale trial in 3 community 
pharmacies and enroll those with/without risk drinking, with a stratified randomization to ABI-MTM (1:1 ratio; risk 
use n=10; non-risk use n=10) or standard medication counseling (SMC; risk use n=10; non-risk use n=10). Out-
come 1: Feasibility will be established through delivery of both ABI-MTM components to 85% of ABI-MTM recip-
ients. Outcome 2: Acceptability will be demonstrated through qualitative interviews, patient satisfaction,33,34 and 
participant retention (85%) at study completion. Outcome 3: Intent-to-treat analyses will show greater proportions 
of ABI-MTM recipients will eliminate co-use of alcohol (risk and non-risk alcohol use) and opioid medications 
compared to SMC assessed by Timeline Follow-Back and urine toxicology.35-37 Product: Accomplishing SA2 
demonstrates ABI-MTM is positioned for a subsequent fully-powered multisite randomized trial.  
SA3: Identify Pharmacy System/Practice-Level Barriers and Facilitators for Universal Alcohol 
Screening/Intervention among Opioid Recipients. Rationale: The barriers/facilitators that may promote/im-
pede adoption of universal alcohol screening/intervention at point of opioid medication dispensing are not known. 
Approach: Employing the Consolidated Framework for Implementation Research (CFIR)38,39 and Organizational 
Readiness to Change Assessment (ORCA),40 we will develop a mixed methods assessment guide to interview 

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PI: Jerry Cochran, PhD 
 
pharmacy technicians (N=20), pharmacists (N=20), and corporate leaders (N=20).41,42 Interviews will assess 
perceptions towards screening/intervention, internal organizational challenges, and processes related to ABI-
MTM implementation for large-scale research/practice.39 Outcome: Results will provide critical insights into strat-
egies for executing a subsequent powered trial and possible future system/practice-level implementation.  
RESEARCH STRATEGY 
SIGNIFICANCE  
Opioids, Co-Use with Alcohol, and How Much is Too Much 
Notwithstanding important declines in opioid prescribing in recent years,43 enough opioids were dis-
pensed in 2018 to supply 51.4 prescriptions per 100 Americans, and 11% of US counties dispensed enough 
medication to supply every person with an opioid prescription.44 This continued widespread use has perpetuated 
trends in opioid-related adverse events. Among the most severe repercussions of the continued epidemic include 
overdose, which in 2018, nearly 70% of the more than 67,000 fatal drug overdoses involved an opioid45—with 
emerging reports indicating spikes in opioid overdose in the face of the COVID-19 pandemic.46 Among the sig-
nificant risks for overdose that persist among those prescribed opioid medications is co-use of alcohol. This 
serious risk is based in both alcohol and opioids acting on μ-opioid receptors1—potentiating analgesic effects of 
these substances and producing possible severe respiratory depression, sedation,2-6 and heightened overdose 
risk.7,8 Previous research has documented more than 1 in 5 individuals with alcohol use disorders also have 
opioid use disorder (OUD)—with some studies showing as high as 2 in 5 having OUD.10,11 Further, among those 
individuals seeking alcohol treatment, nearly 70% reported opioid medication misuse in the month before treat-
ment initiation,12 and half of those with binge alcohol use also report opioid medication misuse in the last month.13 
Combined use of alcohol and opioid medications is not only found among those with alcohol use disorder and 
aberrant opioid use patterns, such as misuse and OUD. Our research among community pharmacy patients has 
demonstrated co-use of alcohol and opioid medications is widespread, showing among patients filling opioid 
medications—approximately 20-30% have current high risk drinking.24,25,47  
A most critical question is how much can a person drink while taking opioids and not face possible harmful 
effects. In working to answer this question, our team has not identified any empirical report, article, textbook, 
guideline, consensus statement, or other literature that indicates how much alcohol can be safely consumed by 
an individual while taking opioid medications for acute or chronic pain management. In contrast, our team found 
extensive literature to the contrary. Human lab studies clearly document respiratory and sedative effects alcohol 
and opioid medications,48,49 with resultant overdose risk, as well as heightened abuse liability for co-use com-
pared to alcohol or opioids used alone.50 Labeling by the Food and Drug Administration of marketed formulations 
of opioid medications contain strong warnings advising against concomitant use of opioids and any other central 
nervous system depressants, specifically citing alcohol.4-6,51 The Centers for Disease Control and Prevention 
clearly concludes: “The risk of harm increases with the amount of alcohol consumed, but there is no safe level 
of alcohol use for people using opioids.”52 NIAAA’s updated, Helping Patients Who Drink Too Much, A Clini-
cians Guide,53 recommends for patients taking prescriptions that interact with alcohol, that these individuals 
abstain from alcohol or consume amounts of alcohol less than maximum daily/weekly limits compared to the 
general population. However, the Clinician’s Guide does not provide actual suggested quantity limits. Taken 
collectively, these data underscore a marked need for interventions to address co-use of alcohol and opioids—
particularly among community pharmacy patients—to prevent negative outcomes including overdose and use 
disorders. Thus, we seek to develop and test an intervention that targets overlapping use of alcohol (risk level 
use and non-risk level use) and opioid medications for delivery in community pharmacies.  
Community Pharmacy to Address Co-Use of Alcohol and Opioid Medications 
Community pharmacy is an underutilized resource and setting for identification and intervention to ad-
dress co-use of alcohol and opioid medications. With prescribers reporting high levels of burden and burnout 
from the myriad of clinical duties,54 the well-documented multiple physical/behavioral health problems among 
patients with pain/opioid misuse,55-63 and the continued nationwide misuse of prescribed opioid medications (>9 
million individuals annually)64— collaborating with auxiliary health care professionals to support opioid prescrib-
ing and patient management is paramount.  As the last healthcare professional encountered before opioid dis-
pensation, the pharmacist is critical in addressing risks of co-use of alcohol and opioids. Moreover, while phar-
macists may benefit from training in psychotherapeutic or motivational approaches for alcohol treatment (as is 
provided in this project), they have unmatched training in drug-drug interactions, medication safety, and coun-
seling in the safe/effective use of medications.65 This study leverages and expands upon this specialized training 
to prevent a harmful medication interaction by providing needed prescriber support with a time critical interven-
tion before opioid dispensation.  
Community pharmacy locations; which include supermarket, chain, and independent settings; are pri-
mary locations where patients legally fill opioid prescriptions that are often taken concurrently with alcohol24,25,47 
or are misused by patients.66,67 Community pharmacies are abundant nationally,68 providing easy access for 
patients—including those in rural areas—creating a platform for population-level impact. Previous research has 

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shown patients are willing to receive behavioral health information from these professionals,69 and pharmacists 
are ranked among the top 2 most trusted professionals in the US.70 While some question if lack of private space 
to interact with patients may be a barrier to pharmacist engagement in behavioral health care with patients, more 
than 40% of community pharmacies have been documented to have private counseling rooms (often used for 
counseling or vaccination administration) where pharmacists can discretely provide care and maintain confiden-
tiality.71 Thus, these specialized service settings and professionals are positioned to make an unparalleled impact 
in identifying patients currently engaged in co-use of alcohol and opioid medications and aid them to eliminate 
alcohol consumption during opioid treatment OR substitute their opioid pain treatment (in consultation with their 
prescriber) with a non-opioid alternative. Yet, limitations for services to address co-use of alcohol and opioids is 
largely rooted in the lack of empirical evidence supporting interventions delivered in this setting as well as iden-
tifying pathways implementation. 
 
INNOVATION 
The primary innovation of this proposed study is that it establishes needed data for building a viable 
community pharmacy-based response to preventing opioid overdose and related adverse events through miti-
gating co-use of alcohol and opioid medications. To our knowledge, a pharmacist-led intervention does not exist 
to specifically target co-use of alcohol and opioid medications. This innovation precisely aligns with the Pilot and 
Feasibility Studies in Preparation for Drug and Alcohol Abuse Prevention Trials program announcement (R34: 
PA-18-775): 
“Both NIDA and NIAAA are interested in research on prevention strategies to address … alcohol use 
simultaneous with marijuana, prescription drug and opioid use, and illicit substances…This FOA encour-
ages pilot and feasibility research on the following and related topics: Feasibility and pilot testing of 
screening and universal brief intervention models to prevent alcohol and drug use and misuse (including 
opioid misuse and opioid use disorder) for delivery in medical settings and the broader healthcare system 
(e.g., primary care, obstetrics and gynecology, pediatrics, adolescent medicine, pain and rehabilitation 
settings, and emergency departments).”  
 
We include community pharmacy among these vital health care settings. In addition to the topical align-
ment of addressing co-use of opioids and alcohol within the novel health care setting of community pharmacy, 
this study likewise brings a critical innovation of adapting a research-based prevention intervention targeting 
possible future system-level implementation. This innovation is also a key focus of PA-18-775:  
“An important emphasis of NIDA’s and NIAAA's prevention research programs is prevention services 
research, which includes questions pertaining to system- and organizational-level processes and mech-
anisms associated with … adaptation …[and]… implementation of empirically validated prevention inter-
ventions in community, practice and service systems. In preparation for large-scale prevention services 
and systems research projects, pilot studies often are needed to: empirically test and establish evidence 
for the feasibility and acceptability of intervention protocols…and implementation strategies…”  
 
APPROACH 
Preliminary Studies 
Given the important potential to address co-use of alcohol and opioid medications in community pharmacies, 
the currently proposed study builds upon critical preliminary data our team has previously established. These 
preliminary data support this work and answer 4 important questions posed as possible barriers. Note to review-
ers: Please be aware that we will use two similar acronyms in this application: (1) BI-MTM, which represents 
Brief Intervention Medication Therapy Management and (2) ABI-MTM, which represents Alcohol-targeted Brief 
Intervention-Medication Therapy Management intervention. BI-MTM will be discussed in reference to our previ-
ously tested intervention that primarily targets misuse of opioid medications. ABI-MTM refers to the intervention 
that will be brought forward in this study that specifically targets the co-use of alcohol and prescription opioid 
medications.  
 Question 1: An often questioned barrier to pharmacists engaging patients in behavioral health services is: 
“Do pharmacists care about intervening with patients with risky opioid medication use behaviors? We con-
ducted a web-based survey of pharmacists in two states about routinely screening and possibly intervening 
with patients engaged in opioid medication misuse behaviors, which results are reported in 2 peer reviewed 
papers.72,73 Of the 739 respondents, most (89.7%) wanted to help patients engaged in opioid medication 
misuse and related behaviors but reported needing training (81.1%) and resources (79.8%) to compe-
tently/effectively do so.72,73  
 Question 2: Another questioned barrier to pharmacist engagement of patients regarding behavioral health 
is: Is it feasible to identify patients at point-of-dispensing using opioid prescriptions and currently engaged in 
concomitant alcohol use? Mentioned above, our team has conducted 3 studies in the previous 5 years with 
community pharmacy patients filling opioid medications, which results have been published in 8 peer re-
viewed papers,23,24,74-79 with a number under review. In these studies, we collectively screened approximately 

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PI: Jerry Cochran, PhD 
 
1,900 pharmacy patients filling opioid medications. Results showed approximately 20-30% of these patients 
reported current risk or binge drinking.24,25,47  
Specifically, Table 1 shows the re-
sults for studies 1 and 2, which took 
place in southwestern Pennsylvania. 
In the first study, we collected Alcohol 
Use Disorders Identification Test-C 
(AUDIT-C) data from patients filling 
opioid medications in 4 community 
pharmacies, which showed 22.4% of 
344 participants reported current risk 
alcohol use.23 Furthermore, in study 2 
(our small-scale RCT testing the BI-
MTM intervention, detailed below in 
Questions 3 and 4) based on the AU-
DIT-C, 19% of 32 participants re-
ported current risk drinking at base-
line. Summarizing item level data across these two projects, 17.4% of participants reported drinking ≥2-3 
times per week; 25.8% of participants reporting ≥3-4 standard drinks on their typical drinking days, and 17.2% 
reported binge drinking ≥monthly. Altogether, these results demonstrate participants in these studies en-
gaged in regular, and often, risky drinking.  
In our third study  in Ohio and Indiana (recently completed), 31% of 1,523 participants filling opioid med-
ications in community pharmacy reported current risk drinking on the Tobacco, Alcohol, Prescription medi-
cation, and other Substance use (TAPS) Tool.26 Examining specific survey items, Table 2 shows 87.1% 
reported use of alcohol in the past 3-months, and 67.7% of males and 50.2% of females reported binge use 
in the last 3-months. Roughly 8-9% of participants had others express concern about their drinking or unsuc-
cessfully had tried to stop/cut down in the last 3-months.  
 Questions 3 and 4: An additional suggested barrier to pharmacist engagement of patients in behavioral 
health services is: Can a pharmacy-centered intervention be adapted to address behavioral health issues 
among pharmacy patients and be implemented in community pharmacies AND would such an intervention 
successfully impact opioid-related risk behaviors? Our research team held a 1-day session in which phar-
macy and addiction experts strategized the adaptation of Screening, Brief Intervention, and Referral to Treat-
ment (SBIRT) for opioid medication misuse among pharmacy pa-
tients, which results were reported in a peer-reviewed article.80 Our 
expert panel advised that the pharmacist deliver SBIRT in conjunc-
tion with the evidence-based practice of Medication Therapy Man-
agement (MTM), targeting medication adherence/misuse. The ex-
pert panel also suggested enriching the pharmacist delivered 
SBIRT/MTM intervention with a Patient Navigation adjunctive inter-
vention to activate patients in self-management of health conditions 
that elevate risk for misuse—this intervention was named: BI-MTM.  
We subsequently implemented the BI-MTM in a small-scale ran-
domized clinical trial (RCT, PI: Cochran, NIDA: R21DA043735) that 
compared BI-MTM (n=15) to Standard Medication Counseling 
(SMC; n=17). We published our findings, which demonstrated feasibility with a 74% recruitment rate and 
>93% retention at the final assessment (3-months).24 BI-MTM feasibility was demonstrated by delivery of all 
pharmacist-led sessions and an average of 7 of 8 patient navigation sessions. BI-MTM acceptability was 
exhibited by high participant satisfaction ratings for pharmacist and patient navigation sessions. Study results 
at the final 3-month assessment showed preliminary BI-MTM efficacy for positive improvements in opioid 
misuse, depression, and pain compared to SMC (all p<0.05)—with strong trends for reductions in opiate 
toxicology (p=0.05).24  
We acknowledge only this pilot study for BI-MTM has been completed—with strong preliminary data cited 
above. Nevertheless, this current application is the product of urgency in the field, documented by 3 clinical 
studies from our research team (also cited above) conducted in 3 separate states across 5 years. These 
preliminary studies each has shown similar high rates of risky drinking among patients receiving opioid med-
ications. Considering this exigency combined with the robust premise of our research program in community 
pharmacy addressing opioid misuse, our team has brought forth this application as a strong candidate to 
address this serious risk behavior of co-use of alcohol and opioids.  
 
Overall, these preliminary studies show pharmacists are interested in engaging patients with opioid re-
lated-risk behaviors; patients with co-use of alcohol and opioid medications are prevalent and can be identified 
Item
Study
#
Never
<Monthly
2-4 times/ 
month
2-3 times/ 
week
>4 times/ 
week
1
52.2
29.9
10.0
5.9
2.1
2
46.9
28.1
15.6
9.4
0.0
1-2
3-4
5-6
7-9
>10
1
86.8
9.6
2.9
0.7
0.0
2
37.5
6.3
6.3
0.0
0.0
Never
<Monthly
Monthly
Weekly
Daily/ 
almost daily
1
61.4
24.5
9.2
3.7
1.2
2
75.0
21.9
3.1
0.0
0.0
Table 1. Percentages of Patients Filling Opioid Medications in Study 1 (N=344) and 2 
(N=32) with Drinking Behaviors  
AUDIT-C
How often drink 
alcohol
Standard drinks 
typical day
>6 drinks on one 
occasion
Past 3 mo use
87.1
Past 3 mo male >5 drinks in a day
67.7
Past 3 mo female >4 drinks in a day
50.2
Past 3 mo others concered about use
8.3
Past 3 mo tried/failed to control, cut 
down or stop use
9.3
Table 2. Percentages of Patients Filling Opioid 
Medications in Study 3 (N=1523) with Drinking 
Behaviors  
TAPS Tool

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PI: Jerry Cochran, PhD 
 
at point-of-dispensing; and an intervention can be adapted/implemented and possesses preliminary evidence 
for patient benefit. The currently proposed study will advance the field by (1) adapting/manualizing an Alcohol-
targeted Brief Intervention-Medication Therapy Management intervention, i.e., ABI-MTM, (2) testing ABI-MTM 
feasibility/acceptability and examining preliminary efficacy for eliminating concomitant alcohol use during opioid 
treatment, and (3) identifying facilitators and barriers for large-scale research and practice implementation.  
Project Investigators  
Principal Investigator: Gerald Cochran, MSW, PhD, is an Associate Professor of Internal Medicine and 
Psychiatry at the University of Utah. Dr. Cochran is an expert in evaluation of evidence-based practices for 
addressing behavioral health conditions and outcomes. He has published more than 80 peer-reviewed articles, 
with the majority related to monitoring/treatment of opioid and other substance misuse/use disorders—including 
risk/binge alcohol use. He has extensive knowledge of brief alcohol interventions delivered in health care settings 
and extensive experience in analysis thereof. He is the Multiple PI of the NIDA Clinical Trials Network Greater 
Intermountain Node and has extensive experience in the management/conduct of multisite trials. He was PI on 
the above discussed preliminary studies (and related grants) and is first author on the related publications. Dr. 
Cochran will be responsible for all aspects of this project. Multiple Principal Investigator: Alina Cernasev, 
PharmD, PhD, is an Assistant Professor of Pharmacy at University of Tennessee. Dr. Cernasev possesses doc-
torate degrees in clinical pharmacy and social and administrative pharmacy, with specialization in qualitative 
methodology. Dr. Cernasev will work closely with Dr. Cochran in day-to-day management of Tennessee study 
staff, training, data collection, intervention delivery, session fidelity, and reporting. Dr. Cernasev will also be 
charged with leading SA3, in collaboration with Drs. Cochran and Ken Hohmeier (coinvestigator, see below).  
Coinvestigators: Adam Gordon, MD, MPH, is a Professor of Medicine at the University of Utah School of 
Medicine and the Section Chief of Addiction Medicine at the Salt Lake VA Healthcare System. Dr. Gordon is the 
PI of the NIDA Clinical Trials Network Greater Intermountain Node. He is board-certified in internal medicine and 
addiction medicine and is an expert in implementation science. Dr. Gordon will provide expertise in high risk 
opioid use, implementation science, and will assist in interpretation of findings and publications. Dr. Ken 
Hohmeier, PharmD is an Associate Professor and Director of Community Affairs for Clinical Pharmacy at Uni-
versity of Tennessee. Dr. Hohmeier’s expertise is in pharmacy management/operations, medication therapy 
management (a critical component of the ABI-MTM intervention), and pharmacist training/education. As Director 
of Community Affairs, he manages relationships with 90 community pharmacy practice locations in state. In this 
study, Dr. Hohmeier will provide community pharmacy practice expertise, aid in management of the clinical phar-
macy sites, and session fidelity review. He will also aid in the intervention protocol manualization. Ralph Tarter, 
PhD is psychologist and Professor of Pharmacy, Psychiatry, and Clinical & Translational Sciences at the Uni-
versity of Pittsburgh. Dr. Tarter has a long history of NIH funded substance use research—including center 
grants, large-scale investigator-initiated awards, and career development. Dr. Tarter has been a long-time coin-
vestigator with Dr. Cochran on the above-mentioned preliminary studies (~10 years). Dr. Tarter is an expert in 
measurement of substance use and related behaviors and will continue work with Dr. Cochran on outcome 
assessment and data analysis/interpretation. Craig Field, PhD is an Associate Professor at the University of 
Texas, El Paso and a clinical psychologist. Dr. Field is an expert in SBIRT for alcohol use and has been PI and 
Co-PI on a number of NIH funded large-scale studies testing these interventions. He is the director of the Latino 
Alcohol & Health Disparities Research Center. He has been coinvestigator with Drs. Cochran, Gordon, and 
Tarter on several of the studies preliminary to the current application. He will provide extensive expertise to the 
team regarding brief alcohol interventions. It is important to note, Dr. Cochran has a number of current and past 
collaborations with the investigators from this team, which require(d) regular/frequent team meetings and com-
munication. Dr. Cochran has published with Drs. Tarter, Gordon, Field, or Hohmeier more than 40 articles com-
bined and with Drs. Tarter and Gordon has received more than a dozen foundation or federally funded research 
grants. Dr. Cochran had recently began a close collaboration with Dr. Cernasev, which since September 2020 
they have coauthored two papers (along with Dr. Hohmeier)81,82 and have submitted 1 grant (not including the 
current application) regarding opioid harm reduction in community pharmacy.  
SA1: Adapt and manualize an Alcohol-targeted Brief Intervention-Medication Therapy Management in-
tervention.  
Rationale. While the BI-MTM intervention, as cited above, has demonstrated promising outcomes for 
mitigating opioid medication misuse, depression, and pain; it was not specially tooled for targeting co-use of 
alcohol and opioids. We will thus systematically adapt BI-MTM to eliminate alcohol use during opioid treatment 
OR to facilitate non-opioid substitution for pain treatment by creating an Alcohol-targeted Brief Intervention-Med-
ication Therapy Management intervention (ABI-MTM), which will leverage and expand upon the unique expertise 
of the community pharmacist in preventing harmful medication interactions. To do so, we will employ the ADAPT-
ITT framework (Assessment, Decision, Administration, Production, Topical Experts, Integration, Training, and 
Testing).32 ADAPT-ITT is a framework originally designed for adapting evidence-based HIV interventions. Given 
the epidemiological nature and health concerns associated with the opioid epidemic and risks associated with 
co-use of alcohol, ADAPT-ITT is a highly appropriate framework to guide the modification of this intervention. 

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PI: Jerry Cochran, PhD 
 
Drs. Cochran (project PI), Tarter, and Gordon (project coinvestigators) have successfully employed the ADAPT-
ITT model in previous collaborations for adapting evidence based interventions,80,83 which interventions have 
been successfully funded for testing in separate clinical trials on which Dr. Cochran was PI and Drs. Tarter and 
Gordon were coinvestigators (NIDA: R21DA043735; CDC: R01CE002996).  
Methods. The following points outline how we will adapt the BI-MTM model to address co-use of alcohol 
and opioid medications using the ADAP-ITT framework.  
 Assessment: Dr. Cochran will provide written materials on the etiology, epidemiology, pharmacology, and 
ways to address co-use of alcohol and opioids to the project expert panel and project investigators with the 
assignment to read and mark up the materials. The expert panel will consist of 4 individuals, including:  
o Michael Moss, MD, Assistant Professor and Medical Director of the Utah Poison Control Center. He is 
also a practicing emergency physician, Data 2000 waivered, and active care provider in the U of U emer-
gency department opioid use disorder bridge clinic. Expertise: Pharmacology/toxicology of opioids.  
o Katie Witkiewitz, PhD, Professor and Director of the University of New Mexico Addictive Behaviors and 
Quantitative Research Lab. She is a licensed clinical psychologist in New Mexico. Expertise: Co-use of 
alcohol and opioid medications. 
o Kenneth E. Leonard, PhD, Professor and Director of the University of Buffalo Clinical and Research In-
stitute on Addictions. Expertise: Co-use of alcohol and opioid medications.  
o Maureen Reynolds, PhD, Research Assistant Professor of Pharmaceutical Sciences at the University of 
Pittsburgh. Expertise: Pharmacist delivery of screening, brief intervention, and referral to treatment.  
Completing materials review, the panel and project investigators will attend a full-day (6 hrs.) recorded web-
conference where: (1) Dr. Moss will present on critical aspects of human pharmacology of alcohol and opioid 
medication use; (2) Dr. Cochran (project PI) will present on clinical characteristics of those who misuse opioids 
and previous research on the BI-MTM intervention; and (3) Dr. Witkiewitz will present on epidemiology and 
clinical implications of co-use of alcohol and opioid medications. The assessment phase of the meeting will also 
involve panel members and project investigators providing brief verbal summaries of their assigned reading 
materials to one another within the group.  
 Decision: Following the presentation and summaries, the web-conference will involve Dr. Cochran facilitating 
a roundtable discussion, eliciting comments and dialog regarding needed intervention modification, and com-
ponents needed for inclusion. This portion will specifically plan how pharmacists will facilitate referral for high 
needs patients (e.g., substance use or mental health disorders). Dr. Cochran will also provide information 
from his previous work regarding warm handoff for high needs patients. A rich literature shows warm-handoff 
is an evidence-based method for connecting individuals with substance use needs, including opioid use, to 
treatment.84-88 
 Administration: Dr. Cochran will instruct the meeting participants to provide specific recommendations on 
how to incorporate the identified components into the intervention that will result in an alcohol targeted inter-
vention for pharmacy patients with co-use of alcohol and opioid medications.  
 Production: Concluding the web conference, Dr. Cochran will request handwritten notes and comments rec-
orded during the Decision phase. Once received, Dr. Cochran will incorporate the identified components into 
the intervention materials/manual.  
 Topical Experts: The adapted intervention manual will be circulated to the project coinvestigators and expert 
panel for review and comment.  
 Integration: Comments and edits from the review will be returned to Dr. Cochran for finalization and incorpo-
ration into the intervention materials/manual.  
 Training: Dr. Cochran will work with Dr. Hohmeier, coinvestigator, (given Dr. Hohmeier’s expertise in train-
ing/education of pharmacists, see investigator section) to author training/instructions for delivery of the 
adapted intervention.  
 Testing: The alcohol adapted intervention will be included within the pilot RCT materials, and co-use of alco-
hol and opioid medications outcomes will be assessed at baseline, 2, and 3 months post-delivery (see SA2).  
Product: Completion of SA1 will result in an adapted/manualized protocol ready for trial evaluation. 
SA2: Test the Feasibility, Acceptability, and Preliminary Efficacy of ABI-MTM for Community Pharmacy 
Patients with Concomitant Alcohol and Opioid Medication Use. 
SA2 Rationale. Possessing the manualized ABI-MTM intervention, it is paramount to assess ABI-MTM’s 
feasibility for delivery in community pharmacy; whether patients will find the intervention acceptable, and if it will 
produce a preliminary clinical effect resulting in elimination of co-use of alcohol. Such a preparatory step is critical 
to demonstrate if ABI-MTM is adequately prepared for subsequent testing within a larger multi-site framework 
and possible eventual system-wide implementation.  
SA2 design and participant identification. We will conduct a small-scale single-blinded 2-group RCT 
(staff administering data collection will be blinded to intervention condition) within 3 Kroger community pharmacy 
locations in the greater Nashville area (2 in metro areas and 1 in a rural location; see Kroger letter of support). 
The rationale for RCT implementation in this location was based on its high rate of opioid overdose rates, high 

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PI: Jerry Cochran, PhD 
 
prescribing rates,89 and high alcohol consumption compared to other states, which alcohol consumption results 
in the state’s status among the top 15 in the US for alcohol related drunk driving deaths90 and the state being 
among the top alcohol-attributable death states in the US.91  
The Kroger pharmacies selected provide a full complement of pharmacy services that attract a highly 
diverse patient population within local communities. Study pharmacists or technicians trained in the screening 
protocol will approach patients dropping off/picking up opioid prescriptions at the counter and ask if they are 
interested in taking a brief confidential electronic tablet-based health screening (<5 minutes), with the opportunity 
of compensation up to $240 if they qualify and enroll in the study. In our small-scale study of BI-MTM, we suc-
cessfully engaged 81% of patients at point of service who presented at the community pharmacies picking up 
medications as well as health plan members who received a study advertisement and came to the pharmacy. 
Patients approached will be asked on a tablet to verify they are English speaking, ≥18 years, and not receiving 
cancer treatment.  
Patients fitting these criteria will move on to being screened for eligibility for receiving ABI-MTM. As stated 
above, given that no scenarios exist where co-use of alcohol and opioids would be advisably safe, we will target 
delivery of the intervention to all patients with overlapping use—both those with risk and non-risk alcohol use. 
Risk drinking will be operationalized by a score of ≥4 or in men and ≥3 or more in women using the valid/reliable 
the AUDIT-C.37,92 Screening will include administration of 5 questions: the 3 items from the AUDIT-C, 1 item 
inquiring when the patient last consumed alcohol, and 1 item inquiring days supply and refills available. Self-
reported alcohol consumption patterns rather than biochemical testing was selected given biochemical testing 
of alcohol use currently has a limited window of detection that could unnecessarily exclude patients who would 
be eligible for intervention receipt.  
The decision flow diagram de-
picted in Figure 1 will be used to deter-
mine ABI-MTM eligibility. The first ques-
tion will be from the AUDIT-C, item 1: 
“How often do you have a drink contain-
ing alcohol?” Responses of ≥2-4 times 
per month indicate eligibility for ABI-
MTM—given participants drinking pat-
terns will likely overlap with any opioid 
medication regimen prescribed to them. 
A response of ≤monthly drinking will trig-
ger the second question: “When was your 
last drink?” Alcohol consumption ≥7 days 
ago indicates eligibility for ABI-MTM—
given that participants’ regular drinking 
pattern could overlap with the current opi-
oid medication. Alcohol consumption of <7 
days will trigger the third question: “How many days of supply and numbers of refills do you have of your current 
opioid medication? We will use this question instead of relying on the Kroger medication record given the patient 
may have prescriptions outside of Kroger. Reponses of ≥7 days current supply indicate eligibility for ABI-MTM 
given that patients’ regular drinking patterns in the month and their medication supply will likely overlap.  
SA2 inclusion/exclusion criteria. Patients eligible for ABI-MTM aged ≥18 will be offered the opportunity 
to learn about the study. Patients will be excluded if they: (1) are pregnant (given potential complications asso-
ciated with pre-natal opioid use93-97 and/or alcohol use98), (2) cannot provide collateral contact information for ≥2 
persons (to ensure consistent contact/follow up), (3) do not have a reliable landline or mobile phone to be con-
tacted by study staff, (4) are filling only buprenorphine (given some formulations are not indicated for pain), (5) 
plan to leave the area for an extended period of time in the next 3-months, or (6) have experienced a psychotic 
and/or manic episode in the last 30 days (before consent, patients will be asked to screen for psychosis [psy-
chosis subscale from the reliable/valid Behavior and Symptom Identification Scale99] and mania [from the relia-
ble/valid Altman Self-Rating Mania Scale100]). We will not exclude patients with severe substance use problems 
given ABI-MTM will possess the capacity to refer and follow up on patient engagement in substance use treat-
ment. Patients excluded will be given educational information about co-use of alcohol and opioid medications, 
and research assistants will aid them to seek additional care if desired. Patients not interested or not co-use 
positive will be rescreened on subsequent visits. Patients positive for co-use, who are interested/eligible, will be 
asked to provide written informed consent to participate. 

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SA2 recruitment feasibility, randomization, sample size, and justification. It is important to note, in 
order to enroll an equal number of participants engaged in risk drinking (n=20) and non-risk drinking (n=20), we 
will sample those with risk and non-risk drinking at a ratio of 1:1. Noted above, our previous research has shown 
that approximately 20-30% of pharmacy patients filling opioid medications have risk use or binge drinking. To 
ensure risk and non-risk drinking status is not strongly collinear with enrollment time, enrollment during the study 
for the larger sample size group may be periodically/temporarily held until 
the smaller sample size group achieves an equal sample size, which 
would occur if the larger group has a sample size of more than 2 greater 
than the smaller sample size group. Once the 1:1 enrollment is met, full 
enrollment will proceed, with this process repeating until recruitment 
ends. Randomization will be stratified to ensure equal distribution of 
those with risk and non-risk drinking into treatment and control groups. 
Randomization will be generated via SAS PROC PLAN, with limited runs 
of 4 to condition assignment.  
 Sample size will not be based on a power estimate. Rather, our 
sample size is based on our experience of how many patients can be 
screened and consented within the study timeframe.101 Using consort 
chart data from our BI-MTM small scale study,102 we present Table 3 that 
demonstrates our estimates of how many patients we anticipate needing 
to approach/screen to meet our recruitment target within our study time-
line. Based on these data, we will need to approach 338 patients during the study recruitment phase. Of these, 
we anticipate 81% will be interested/available for screening, of whom approximately 50% will meet eligibility 
criteria (most patients will be ineligible because they will not have co-use of alcohol and opioid medications). 
From among the eligible patients who are positive for co-use of alcohol and opioid medications, we anticipate 
27 will be positive for risk drinking, and 110 will be positive for non-risk drinking. We anticipate consenting 74% 
of those interested in participation and eligible—including consideration of our procedure mentioned above of 
1:1 recruitment of individuals with risk/non-risk use—which will result in our final population to be randomized: 
N=40 (ABI-MTM: risk use n=10; non-risk use n=10; SMC: risk use n=10; non-risk use n=10). Randomization will 
be stratified by pharmacy site. 
In terms of needed time to recruit our targeted patient population, based on our data from our recently 
completed research study (mentioned above) at 19 Kroger sites and based on our previous screening study and 
small scale study, we expect to approach 9 patients for recruitment monthly at each of our pharmacy loca-
tions.23,25,102 With this rate and based on our procedure mentioned above of 1:1 recruitment of individuals with 
risk/non-risk alcohol use, study recruitment will require approximately 13-months to complete. We have chosen 
to focus recruitment at a limited number of sites (N=3) during feasibility/acceptability/preliminary efficacy testing 
to ensure internal validity of our procedures, limiting possible site variation, and limiting multisite challenges. 
During screening, we will capture sex, insurance status, and age for all eligible patients to assess basic demo-
graphic differences among those who participate versus those that do not.  
While definitive estimation and hypothesis testing are not the aim of this study, the target sample size will 
allow estimation of odds ratios via 95% confidence intervals comparing outcome rates in the intervention and 
control arms, while accounting for within site clustering, with lower bounds differing from the odds ratio estimate 
by a factor of 1/3 to 1/2 and upper bounds differing from the odds ratio estimate by a factor of 2 to 3 for a broad 
range of overall rates, true odds ratios, and magnitude of site-to-site effects. In particular, this study will allow 
detection of strong signals of preliminary benefit and provide suggestions of benefit for more subtle signals.  
SA2 treatment-as-usual and intervention conditions. Standard Medication Counseling (SMC) will be 
the treatment as usual condition in this study and was chosen/developed following Gold et al.’s guide for select-
ing control conditions in behavioral intervention studies.103 For the first component, all SMC participants will 
receive a single 5-10 minute medication information/counseling session delivered by a Kroger pharmacist, other 
than the study pharmacist, that possesses a similar level of education and professional licensing. The content of 
this session follows federal and state pharmacy requirements104,105 requiring pharmacists to: (1) offer counseling, 
(2) document counseling was offered, (3) offer a counseling process for patients not present (not applicable to 
this study given all patients must screen in person), and (4) discuss generic substitution.104,106 Following this 
session, in the second SMC component, participants will be emailed/mailed (according to participant preference) 
safety information about co-use of alcohol and opioids. Pharmacists delivering SMC will be provided information 
quarterly to remind of practice standards for SMC service delivery by Dr. Hohmeir. SMC is specifically yoked in 
duration with ABI-MTM, totaling 2 participant contacts to control for attention bias in outcome assessment. It is 
important to note all study participants will receive SMC given state and federal requirements. 
Alcohol Brief Intervention-Medication Therapy Management (ABI-MTM) will be the intervention condition 
adapted and prepared for utilization in this study. ABI-MTM sessions will be set by appointment between the 
pharmacist and the participant. The study pharmacist will possess a PharmD degree and be licensed. Study 
Table 3: Recruitment Projections 
n a 
Total needed to approach 
338 
Interested in screening (81%) 
373 
Screening eligible after anticipated 
exclusion (50%) 
137 
Not risk drinking (~ 80%) 
110 
Risk drinking (~ 20%) 
27 
Consented and randomized (74% 
of those with risk drinking + those 
with non-risk drinking) 
40 
a Rate estimates based on pilot study consort 
chart numbers.  

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PI: Jerry Cochran, PhD 
 
pharmacist training will be led by Drs. Cochran, Cernasev, and Hohmeier. Training entails: the pharmacist pre-
reading/studying the protocol followed by 2-days of motivational interviewing training tailored to the protocol, 
including lecture, group discussion, and observed role-plays (motivational interviewing training will provided in 
Nashville by Kali Worley, PhD, MA; a Nashville-based Motivational Interviewing Network of Trainers [MINT], 
trainer; see letter of support). Following in-person training, mock sessions are conducted/recorded and assessed 
using fidelity checklists. Drs. Cochran, Cernasev, Worley, and Hohmeier will adapt and prepare fidelity checklists, 
including a protocol adherence checklist and motivational interviewing scoring sheet, which will be modified from 
BI-MTM materials employed in the small-scale study cited above. The protocol adherence checklist will be re-
viewed and scored by Drs. Cochran, Cernasev, and Hohmeier, with the study pharmacist required to demon-
strate ≥80% proficiency on the protocol checklist to be permitted to interact with study participants (80% being 
an acceptable level based on Dr. Cochran’s previous experience training staff in similar interventions). For initial 
Motivational interviewing proficiency, Dr. Worley will code training sessions using the Motivational Interviewing 
Treatment Integrity Code (MITI 4)107,108 and will ensure fair/basic competency on technical and relational global 
scores as well as complex reflections and ratio of reflections to questions.107,108 Ongoing session fidelity will be 
monitored by review of session recordings (all pharmacist sessions will be audio recorded to ensure delivery and 
for fidelity review). With these recordings, each month, investigators and staff will (including Dr. Worley): (1) 
review randomly selected recorded sessions using the protocol checklist and MITI 4, (2) provide verbal/written 
feedback, and (3) participate in a group discussion. 
While details regarding the various components, specific language, and materials of the intervention and its 
manual for delivery will be determined and produced as the primary outcome of SA1, the framework of the ABI-
MTM intervention (similar to BI-MTM) will be based in MTM (i.e., medication therapy management) and SBIRT 
(i.e., screening brief intervention, and referral to treatment). MTM is an evidence-based intervention delivered in 
community pharmacy involving a brief session where medications are reviewed, and patients are assisted to 
resolve barriers to adherence. MTM has been documented to improve medication adherence.27 While lack of 
payment has been cited as a possible barrier for many services in community pharmacy settings, MTM is reim-
bursable by Medicare and several commercial insurance plans.109 A core goal of MTM is to empower patients in 
active medication self-management.110,111 MTM in the current study will be based on the American Pharmacists 
Association and National Association of Chain Drug Stores Foundation service model, which includes 5 core 
elements.112 A common duration for medication counseling in outpatient pharmacies a single 30-45 minute ses-
sion;113 we anticipate ABI-MTM session duration to be similar. Session 1 will be in-person; however, if in-person 
visits are not possible (e.g., COVID-19 restrictions), both sessions may occur telephonically.  
 Element 1 is a medication review. In this element, the pharmacist collects patient specific information related 
to the medication regimen and their health and prioritizes any identified problems.  
 Element 2 develops a personal medication record. In this element, the pharmacist and the patient develop a 
list of the medications the patient is taking. This list also documents patient and health care provider contact 
information, problematic interactions, allergies, review date, and medication details.  
 Element 3 produces a medication action plan. This plan includes steps the patient must take to improve 
medication self-management and their health.  
 Element 4 is the intervention and/or referral. This is where the pharmacist would employ SBIRT to work with 
the participant to either choose (1) to eliminate alcohol use during opioid therapy OR (2) to facilitate commu-
nication with the prescriber to select a non-opioid pain management alternative. SBIRT is an evidence-based 
practice for improving alcohol problems,28-31 with demonstrated evidence from pharmacists and other provid-
ers for medication adherence improvement114-118 and reductions in problematic prescription opioid use.24,119-
121 It is highly important to note that in the current application context, SBIRT targeting elimination of co-use 
of alcohol and opioids (i.e., alcohol use elimination during opioid treatment OR non-opioid pain management 
substitution) is designed to prevent related sequelae, i.e., possible overdose risk and use disorders. We do 
recognize, however, some participants may not choose the non-opioid pain treatment option and also be 
ambivalent about elimination of alcohol use. These participants will be encouraged to reduce alcohol use.  
 Element 5 includes documentation and follow up. Documentation includes the pharmacist recording 
notes/action items related to elements 1-4. The follow-up (booster session) portion includes scheduling a 
telephonic session 7 days following the initial visit, during which the pharmacist reviews commitments made 
during the initial session, works to resolve barriers, and provides additional referrals/resources.  
SA2 assessment, follow up, and retention. Participants will be assessed at baseline, 2-months, and 
3-months post-randomization at the Kroger community pharmacy settings or other appropriate locations. Partic-
ipants will be compensated $40 for the baseline assessment, $50 for the 2-month, and $75 for the 3-month—
with a $75 completion bonus for those completing all assessments. Research assistants will aid participants to 
complete self-administered portions of the questionnaires as necessary to prevent missing data and ensure 
accurate/completed assessments. Research assistants will also be trained to administer urine toxicology as-
sessments to participants. Efforts to ensure continued participant contact include collecting locator information 
and at least 2 collateral contacts as well as sending letters and cards, electronic messages, and making phone 

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PI: Jerry Cochran, PhD 
 
calls. Noted above, these retention methods were successful in the BI-MTM study, resulting in >93% retention 
at the final study follow up.102 
SA2 intervention feasibility and acceptability outcome measurement. Achievement of feasibility of 
delivery of all intervention components to 85% of ABI-MTM recipients will be captured by the pharmacist logging 
completed intervention components. Achievement of ABI-MTM acceptability will be assessed at month 3 and 
will be captured by intensive qualitative interview following a semi-structured interview guide focusing on partic-
ipant opinions/experience with ABI-MTM. Acceptability will also be captured at month 3 by assessing patient 
satisfaction using the Patient Satisfaction Survey for Comprehensive Medication Management (PSSCMM),33 a 
reliable and content/factorially valid 10-item self-report instrument33 that will assess patient satisfaction with in-
tervention. Last, acceptability will also be assessed by intervention recipient retention (85%) at study completion. 
SA2 preliminary efficacy outcome measurement. This aim postulates that intent-to-treat analyses will 
show greater proportions of ABI-MTM recipients will report elimination of co-use of alcohol and opioid medica-
tions compared to SMC.35,36 Our primary assessments will include: 
 Timeline Follow Back (TLFB) assesses quantity/frequency of alcohol and opioid medication use, which is a 
measure that is reliable and is content, criterion, and construct valid.35,36 Also note, we will capture any illicit 
drug use with the TLFB.  
 14 panel drug urinalysis will be collected in private restrooms of the pharmacies or other appropriate loca-
tions, which will capture opiates, oxycodone, methadone, cannabis, cocaine, PCP, amphetamine, MDMA, 
methamphetamine, barbiturates, benzodiazepines, buprenorphine, tricyclic antidepressants, and propoxy-
phene. Participants are considered co-use free if self-report and urine assessments coincide.  
In addition to our primary outcome measures, we will also capture concomitant conditions as covariates 
at each time point. Each of these conditions are well known correlates of opioid related risk, substance use, and 
health behavior change: 
 
Opioid Use Behaviors122,123 
 Prescription Opioid Misuse Index (POMI), a 6-item criterion valid and reliable measure that assesses pre-
scription opioid misuse behaviors and opioid medication misuse.124  
 Opioid Compliance Checklist (OCC), an 8-item, a test/retest reliable and criterion valid tool125-127 that as-
sesses adherence/misuse to the prescribed opioid regimen. 
 Diagnostic Statistical Manual-5 Checklist for Opioid Use Disorder, is an 11-item reliable and valid assess-
ment that identifies mild, moderate, and severe opioid use disorder. 128,129 
Pain and Physical Health130-133 
 Brief Pain Inventory, is a well-validated and reliable assessment, which consists of a 4-item pain intensity 
subscale and a 7-item pain interference subscale.134  
 Pain Catastrophizing Scale, a 13-item factorially/concurrent/discriminant valid and reliable assessment135 
that measures rumination, magnification, and helplessness aspects of pain catastrophizing.  
 Short Form-36 (SF-36) will assess physical health and is a 36-item content, criterion, and construct valid 
measure with demonstrated reliability.136 This measure assesses physical functioning, role functioning, bodily 
pain, general health, vitality, social functioning, emotional functioning, and mental health.  
Mental Health and Risk Alcohol Use47,122,123 
 Patient Health Questionnaire (PHQ) will assess mental health and is an 11-item criterion valid mental health 
assessment with demonstrated reliability.137-140 The PHQ assesses depression, anxiety, somatoform, eating, 
and alcohol use disorders. This assessment will also be used to monitor suicidal ideation across time.  
 Primary Care-Posttraumatic Stress Disorder assessment will measure post-traumatic stress disorder, which 
is a 5-item criterion valid and test-retest reliable instrument.141-144  
 Alcohol Use Disorders Identification Test-C (AUDIT-C) is a 3-tem abbreviated version of the AUDIT-10, which 
has demonstrated internal consistency and test-retest reliability and construct and criterion validity.37,92 The 
AUDIT-C has highly similar performance as the full version37,92 and assesses frequency, quantity, and binge 
drinking (note, the AUDIT-C will be administered at screening [not baseline], 2-, and 3-months assessments). 
 WHO Alcohol, Smoking, and Substance Involvement Screening Test alcohol subscale will be used to assess 
lifetime and recent alcohol use. This 7-item measure has demonstrated reliability as well as criterion, con-
struct, concurrent, discriminant validity.145   
Engagement in Physical Health and Psychosocial Services  
 Treatment Services Review (TSR)-6 will assess engagement in services for: substance abuse, medical/men-
tal health, family issues, financial/housing needs, and legal concerns. The TSR-6 also captures medication 
use; which we will use to capture type, dose, and frequency of opioid consumption and other medications. 
The TSR contains 56-items and is criterion and construct valid and reliable.146-149 The TSR will be used, in 
particular, to identify length of the written opioid prescription, which will allow for examination of elimination 
of co-use during the opioid treatment. This will also allow for monitoring of natural cessation of opioid use 
during the course of treatment 

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PI: Jerry Cochran, PhD 
 
Readiness to Change150,151 
 The Readiness to Change Questionnaire is a 12-item assessment of individual readiness to change drinking 
behaviors that evaluates three of the stages of change: pre-contemplation, contemplation, and action. This 
assessment has content, criterion, and construct validity—with test-retest reliability.152-155 
Social Desirability 
 The Marlowe-Crowne Social Desirability Scale and short Form contains 13 items and is criterion valid156,157 
and reliable. This measure will assess the participants’ degree of social desirability at each time point. 
SA2 acceptability and feasibility analysis plan. Successful delivery of all intervention components will 
be analyzed by calculating the total number recipients that received both ABI-MTM sessions divided by the total 
number of participants randomized to this condition. Intensive qualitative interviews of ABI-MTM acceptability 
will be analyzed following methods recommended by Braun and Clarke that capture associations between cat-
egories, extract, and conceptualize themes.158 Our team will independently review the interview data and code 
inductively and deductively. Codes will be clustered based on their similarities into categories. The research 
team will meet multiple times to discuss the emergent themes.158 Patient satisfaction with the intervention re-
ported on the PSSCMM will be analyzed by calculating frequencies of responses, measures of central tendency, 
and proportions. Treatment retention of 85% of ABI-MTM recipients at study completion will be analyzed by 
calculating number of recipients retained at 3-months divided by number of consented recipients.  
SA2 preliminary efficacy analysis plan. This aim compares the preliminary efficacy of the intervention 
(ABI-MTM vs. SMC) on the primary binary co-use outcome (i.e., co-use vs. no co-use of alcohol and opioid 
medications). Mentioned above, successful elimination of co-use can be in the form of (1) participants eliminating 
their alcohol consumption while they are receiving opioid therapy, which will be measured by the TLFB, OR (2) 
by choosing an alternative non-opioid pain management strategy (not altering their alcohol consumption) by 
recommendation of the pharmacist and in collaboration with their prescriber, which will be measured by agree-
ment of urine toxicology and TLFB.  
We will first provide descriptive summaries of each variable measured at baseline, 2-, and 3-months 
overall, by risk/non-risk alcohol use, as well as by intervention group (note that all included participants are 
positive for co-use at baseline). Within an intent-to-treat framework, we will fit 3-level generalized linear mixed 
models (GLMM) to relate repeated assessments across time of the primary outcome measured (i.e. elimination 
of co-use) to the intervention. Additional analyses within the 3-level GLMM framework will also be conducted to 
assess the overall impact of the intervention on reducing percent days alcohol use among patients during the 
prescribed opioid treatment period. All analyses will be adjusted for covariates likely to be associated with the 
outcome. Specifically, this will include baseline measures such as opioid use, mental health, substance use, 
pain/physical function, social services utilization, and readiness to change in addition to and demographic co-
variates including (but not be limited to) age, sex, race, socioeconomic status, and rural/urban living.159 Social 
desirability156,157 will also be included as a time varying covariate to account for the degree to which participant 
response bias may impact study outcomes. Random intercepts will be used to account for correlations on the 
patient level and pharmacy site level. We will also test risk/non-risk alcohol use as an effect modifier to determine 
whether the intervention has a differential impact on individuals with distinct levels of drinking; we recognize, 
however, the sample study sample size may limit the power of the analysis to detect changes at a probability of 
<0.05. Thus, it is important to note our above discussed analysis focus on 95% confidence intervals comparing 
outcome rates in the intervention and control arms in order to detect subtle trends in relation to intervention 
efficacy. Model parameters, including treatment effects at each follow-up, will be estimated using restricted max-
imum likelihood.160 An advantage of this approach is treatment effect estimates remain consistent and approxi-
mately unbiased if missing data follow a missing-at-random pattern (MAR; data values are independent of the 
missingness mechanism conditional on the observed data161), the most general data-centric missing data as-
sumption.  
As biological sex is an important factor among individuals with pain and opioid/alcohol use,162,163 we will 
explore differences by intervention group and biological sex for SA2. Based on our previously published research 
in this population, we anticipate recruiting ~57% females/~43% males24,164 in this study. We will first examine 
descriptive demographic differences at baseline, 2-, and 3-months within the ABI-MTM and SMC conditions by 
sex. Next, to explore the potential role of sex as an effect modifier for ABI-MTM on co-use, we will test interaction 
terms between the intervention group and sex to explore possible heterogeneity of treatment effects and to 
characterize if sex subgroups might benefit more from the intervention. As discussed above with reference to 
the risk/non-risk alcohol use as an effect modifier analyses, sex subgroup analyses will likewise focus on 95% 
confidence intervals comparing outcome rates in the intervention and control arms in order to detect subtle trends 
in relation to intervention efficacy. 
SA2 product. By successfully accomplishing SA2, this will establish the necessary feasibility, accepta-
bility, and preliminary efficacy data to demonstrate ABI-MTM is ready for a subsequent fully powered multisite 
randomized trial. 

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PI: Jerry Cochran, PhD 
 
SA3: Identify Pharmacy System/Practice-Level Barriers and Facilitators for Universal Alcohol Screen-
ing/Intervention among Patients with Opioid Medications.  
SA3 rationale. We have discussed above a number of barriers to pharmacists engaging patients regard-
ing behavioral health. While our previous research has worked to address these barriers, the process of applying 
evidence-based services into real world health care settings is a paramount aspect of evidence-based imple-
mentation science and involves rigorous planning, monitoring, and evaluation165-167 and indeed requires thought-
ful preparation. Therefore, SA3 focuses on implementation planning to identify what barriers exist for implement-
ing universal alcohol screening/intervention for those using opioid medications for a subsequent large-scale 
multi-site efficacy trial as well as eventual integration into system-level commercial pharmacy chain workflow. 
Likewise, this step will also identify facilitators to scaling alcohol screening/intervention for those who use opioid 
medications for a large-scale multisite trial and pharmacy system wide. To establish this information, we will 
employ tools from the Consolidated Framework for Implementation Research (CFIR)38 and organizational be-
havior and management. The CFIR is a multidimensional framework comprised of constructs for drawing out 
information related to implementing research into practice,168 ranging from pre-implementation activities to post-
implementation outcome analyses.169-171 The CFIR has been employed within a variety of clinical and adminis-
trative areas, including healthcare delivery and processes redesign, quality improvement, health promotion, and 
disease management as well as in clinical areas including mental health, obesity, and high blood pressure.168  
SA3 design and participant identification. We will implement cross-sectional one-time mixed methods 
key informant interviews to capture data that will inform our understanding of pharmacy system/practice-level 
barriers and facilitators for universal alcohol screening/intervention among patients with opioid medications. In-
terview participants will be identified through a purposive/snowball sampling approach. Relying on both on Dr. 
Hohmeier (project coinvestigator) and Dr. Stacey Frede’s (project consultant) professional networks at the 
Kroger corporate and Nashville regional levels, our team will reach out and offer interview participation to indi-
viduals in each category of key informant (technicians, pharmacists, and corporate leaders). Dr. Frede is the 
national Manager of Clinical Program Development with the Kroger Health Corporate office who has been a  
close collaborator with Dr. Cochran over the past 3 years in his NIDA CTN funded research project (CTN-0093; 
see letter of support). Identified interviewees will be contacted via email and/or by telephone. Interviews will take 
place in a location and time that is convenient and selected by the participants. The interviews will be conducted 
by a research assistant trained in qualitative interviewing and are anticipated to last up to 1 hour. At the close of 
these interviews, the research assistant will request from the participant suggestions of other individuals who 
would represent the specific perspective of pharmacy corporate leaders, pharmacists, and technicians. Com-
pleting the interview, participants will be provided with a $75 gift card. 
SA3 assessment. Prior to meeting in-person for the qualitative interview, the first step in our mixed 
methods assessment will involve the quantitative data collection. We will administer, via a web-based survey 
platform, the internally consistent reliable and factorially valid Organizational Readiness to Change Assessment 
(ORCA).40 This 77 item instrument assesses organizational readiness for implementing evidence-based prac-
tices in clinical settings. Primary domains assessed by the instrument include respondents’ perceptions of 
strengths of evidence for the change and ability of the organization to support the change.40  

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PI: Jerry Cochran, PhD 
 
For the in-person portion of the interview, we will administer open-ended questions drawn and adapted 
from the CFIR interview guide for qualitative research. Items will be selected by the research team in collabora-
tion with Dr. Frede. Items from the constructs set forth in Table 4 will be employed39 and include Intervention 
Characteristics, Inner Setting, Characteristics of Individuals, and Process. Our team has previously employed 
CFIR constructs along with the CFIR interview guide to develop an open-ended survey schedule for administra-
tion to health care professionals regarding substance use care within health care settings,172,173 which interview 
results were used for system-level and community-wide intervention/ implementation planning. Also mentioned 
above, Dr. Gordon is an expert in implementation science and has more than 20 years of experience in this area.  
Sample size. We will recruit pharmacy technicians (N=20), pharmacists (N=20), and corporate leaders 
(N=20) to complete the SA3 interview.41,42 Previous research has demonstrated sample sizes of 20 individuals 
or less can achieve close associations between the researcher and the participants, which will generate rich data 
needed for elucidating complex re-
lationships.41 
Previous 
research 
has also demonstrated samples of 
approximately 12 interviews can 
reach 
saturation 
of 
findings.42 
Saturation has been defined as a 
point beyond which no significantly 
new information is being obtained. 
Saturation will be discussed and an-
alyzed by the research team after 
each interview has been completed. 
Lincoln and Guba’s framework174 
will be used to address and meet 
criteria for quality and rigor in this 
study and involve credibility, de-
pendability, 
confirmability, 
and 
transferability.174  
SA3 analysis plan. For the 
quantitative survey items collected 
based on the ORCA survey, we will 
employ descriptive analyses as well 
as conduct chi square and One-
Way ANOVA tests to examine dif-
ferences 
between 
interviewed 
groups 
(pharmacy 
technicians, 
pharmacists, and corporate lead-
ers). For the qualitative data, similar 
to SA2, the research team will follow 
methods recommended by Braun 
and Clarke that will capture associ-
ations between categories and ex-
tract and conceptualize themes.158 
The researchers will independently review the interview data and code inductively and deductively. Codes will 
be clustered based on their similarities into categories. The research team will meet multiple times to discuss 
the emergent themes.158  
Timeline. Based on our previous work in conducting clinical research with similar populations in commu-
nity pharmacy settings, we estimate this study will require 3 years to complete (Table 5). Year 1 quarters (Q) 1-
3 will involve receiving IRB approval and hiring/training staff. During the same time, we will undertake and com-
plete all activities related to SA1, intervention adaptation and protocol development. Year 1 Q 2-3 will involve 
finalizing the assessment battery for SA2; Q3 will also involve the initiation of activities related to the small-scale 
Table 4. Consolidated Framework for Implementation Research Constructs in SA3 Key Informant 
Survey Development 
Intervention 
Characteristics 
Evidence 
Strength and 
Quality 
Stakeholders’ perceptions of the quality and validity of evidence 
supporting the belief that the intervention will have desired 
outcomes. 
Relative  
Advantage 
Stakeholders’ perception of the advantage of implementing the 
intervention versus an alternative solution. 
Trialability 
The ability to test the intervention on a small-scale in the 
organization, 
and to 
be 
able 
to 
reverse course 
(undo 
implementation) if warranted. 
Complexity 
Perceived difficulty of the intervention, reflected by duration, scope, 
radicalness, disruptiveness, centrality, and intricacy and number of 
steps required to implement. 
Inner Setting 
Implementation 
Climate 
The absorptive capacity for change, shared receptivity of involved 
individuals to an intervention, and the extent to which use of that 
intervention will be rewarded, supported, and expected within their 
organization. 
Relative Priority 
Individuals’ shared 
perception 
of the 
importance 
of 
the 
implementation within the organization. 
Leadership 
Engagement 
Commitment, involvement, and accountability of leaders and 
managers with the implementation. 
Available  
Resources 
The level of resources dedicated for implementation and on-going 
operations, including money, training, education, physical space, 
and time. 
Characteristics 
of Individuals 
Knowledge and 
Beliefs about 
the Intervention 
Individuals’ attitudes toward and value placed on the intervention as 
well as familiarity with facts, truths, and principles related to the 
intervention. 
Process 
Engaging  
Attracting 
and 
involving 
appropriate 
individuals 
in 
the 
implementation and use of the intervention through a combined 
strategy of social marketing, education, role modeling, training, and 
other similar activities. 
Champions 
Individuals who dedicate themselves to supporting, marketing, and 
‘driving through’ an implementation overcoming indifference or 
resistance that the intervention may provoke in an organization. 

Version 1.0; 11Mar2022 
PI: Jerry Cochran, PhD 
 
trial, including patient recruitment, inter-
vention delivery, outcome assessments 
and data safety monitoring board meet-
ings (DSMB), which will conclude in 
Year 3 Q1. Beginning in Year 1 Q4, we 
will initiate our activities related to SA3, 
including developing our qualitative in-
terview schedule, participant identifica-
tion, interviewing, and analyses, which 
will conclude Year 3 Q1. Study papers 
will be produced Year 1 Q3-4 and Year 
3 Q2-4.  
Possible Barriers to Study Success 
and Resolutions 
 
We anticipate 3 primary barriers 
to the success of this study and have 
plans in place for response and/or reso-
lution. First, critics may suggest that 
providing an intervention to those with 
non-risky alcohol use who are also tak-
ing opioid medications is unnecessary 
given they are at low probability for neg-
ative consequences. It is important to recall, as reviewed/cited above, there is no empirical literature that sup-
ports this perspective—rather all-peer reviewed human and animal, governmental, packaging inserts, and pro-
fessional literature available clearly state that any co-use of alcohol and opioid medications is dangerous and 
should be not done. Therefore, this study will specifically recruit on a 1:1 ratio those with non-risk as well as 
those with risky alcohol use and examine outcomes for both subgroups by intervention condition. 
Second, some critics may also assert that given the BI-MTM intervention already has been developed 
and tested in a small-scale clinical trial, that advancing ABI-MTM is unnecessary and BI-MTM should be sufficient 
for co-use of alcohol and opioid medications. Our team deliberated over this question extensively. Opioid medi-
cation misuse is a composite set of behaviors including, for instance, using more medication than prescribed, 
using to get high or to cope with problems, and doctor shopping. Misuse also is frequently accompanied by a 
variety of concomitant conditions (i.e., mental health, illicit substance use) that together require a resource in-
tense and comprehensive intervention. Our goal with the ABI-MTM intervention is to integrate a very brief and 
targeted intervention focusing only on the highly specific outcome of co-use elimination (i.e., [1] eliminating al-
cohol use during opioid treatment or [2] substituting a non-opioid pain therapy). Thus, ABI-MTM will be very 
different in practice than the BI-MTM—requiring specific adaptation efforts and preliminary testing.  
Third, we do not anticipate a change in our ability to recruit participants in SA2 (i.e., pharmacy patients); 
however, there is a chance recruitment could slow at some point in the study. Given the hundreds of Kroger 
stores in Tennessee (and thousands across the US) and our close collaboration with corporate and local leaders 
on this project, should participant recruitment become a challenge, we have the ability to open up recruitment in 
other stores and/or create Kroger medication system hard stops in the store workflow that would require patients 
to be screened before leaving the stores. Based on our experience, these are highly effective tools that can be 
used to improve site performance. In the same vein, based on our close collaboration with corporate and local 
leaders, we are confident that should our sampling approach for SA3 (i.e., staff/leadership key informant inter-
views) prove to not meet our targets, our local and corporate partners will help assist us to identify additional 
possible participants who would be available and potentially interested with speaking with us.  
 
CONCLUSION  
The opioid epidemic continues to result in serious negative consequences in the US. While some im-
provements have been observed for reductions in prescribing in recent years; high rates of misuse, subsequent 
OUD, and overdose persist. Among the most high-risk behaviors for those taking opioid medications is co-use 
with alcohol. The Centers for Disease Control and Prevention has clearly stated: “…there is no safe level of 
alcohol use for people using opioids.”52 Previous research, including that of our team, shows that a significant 
portion of those regularly using opioids medications—particularly filling opioids at community pharmacies—are 
involved in the co-use of alcohol. This study proposes to leverage pharmacists’ special training in medication 
interactions and safety; adapt a previously developed intervention for opioid medication misuse; test its accept-
ability, feasibility, and preliminary efficacy; and identify barriers/facilitators to large-scale research and system-
level implementation. Results will inform a subsequent powered multisite trial examining the impact of the ABI-
MTM intervention on reducing co-use of opioid medications and alcohol and improve public health nationally. 
Aim Activity
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
1-3 IRB approval
x
Hire staff
x
x
x
Train staff
x
x
1
Adapt intervention 
x
x
Adapt/expand protocol
x
x
Finalize study protocol
x
x
2
Finalize assessment battery
x
x
Patient recruitment
x
x
x
x
x
Intervention delivery
x
x
x
x
x
x
Outcome assessments
x
x
x
x
x
x
x
DSMB meetings
x
x
x
x
x
x
x
Data cleaning/analyses
x
x
Protocol paper
x
x
Main outcome paper
x
x
x
3
Develop qualitative interview 
x
x
Identify participants
x
x
Administer survey/interview
x
x
Data analysis
x
x
Main outcome paper
x
x
x
1-3 Submit final report
x
Year 1
Year 2
Year 3
Table 5. Project Timeline

Version 1.0; 11Mar2022 
PI: Jerry Cochran, PhD 
 
 
 
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