Alcohol Drinking, Opioid Use
Conditions
Brief summary
Previous research, including that of this team, shows that a significant portion of those regularly using opioids-particularly filling opioids at community pharmacies-also are involved in the co-use of alcohol. This study proposes to adapt a previously developed intervention for opioid medication misuse; test its acceptability, feasibility, and preliminary efficacy; and identify barriers and facilitators to large-scale research and system-level implementation. Results of this study will directly inform a fully-powered subsequent multisite trial.
Detailed description
Co-use of alcohol and opioid medications is known to be a serious health/safety hazard-yet persists despite these negative ramifications. With limited information available within peer-reviewed literature, large-scale system and clinical research have demonstrated 24-38% of those with alcohol use disorders also have an opioid addiction, with rates of past 30-day opioid medication misuse among those seeking alcohol treatment as high as 68%. Research from this group has shown that among community pharmacy patients receiving opioid medications for pain management, approximately 20-30% are engaged in co-use of alcohol. Community pharmacy is a highly valuable but underutilized resource and setting for identification and intervention to address the US opioid epidemic. The investigators 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 intervention, combined with Screening, Brief Intervention, and Referral to treatment that will target: (1) alcohol use elimination during opioid treatment OR (2) non-opioid pain management substitution (in consultation with the prescriber). The investigators will conduct a small-scale trial in 3 community pharmacy locations wherein the investigators will randomize patients with heavy alcohol use and with non-heavy alcohol use (1-to-1 ratio) to ABI-MTM (n=20) or standard medication counseling (SMC, n=20). Results will demonstrate intervention acceptability, feasibility, and preliminary efficacy. This study will also work to identify pharmacy system and practice-level barriers and facilitators for universal alcohol screening and intervention among opioid recipients. This study will also work to identify pharmacy system and practice-level barriers and facilitators for universal alcohol screening and intervention among opioid recipients. The investigators will develop a mixed methods assessment guide to interview pharmacy technicians (N=20), pharmacists (N=20), and corporate leaders (N=20). Interviews will assess perceptions towards screening/intervention, internal organizational challenges, and processes related to ABI-MTM implementation for large-scale research and practice. Altogether, results of this study will provide critical insights, foundational data, and strategies for executing a powered trial and possible future system/practice-level implementation.
Interventions
BEHAVIORALAlcohol-targeted Brief Intervention-Medication Therapy Management
Alcohol-targeted Brief Intervention-Medication Therapy Management (ABI-MTM) intervention is a pharmacy-based medication management intervention, combined with Screening, Brief Intervention, and Referral to Treatment. ABI-MTM includes 5 core elements. A common duration for medication counseling in outpatient pharmacies a single 30-45 minute session. These include a medication review, a personal medication record, a medication action plan, a brief motivational intervention, and documentation and follow up.
BEHAVIORALStandard medication counseling
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 selecting control conditions in behavioral intervention studies. For the first component, all SMC participants will receive a single 5-10 minute medication information/counseling session delivered by a 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 requirements 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. 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.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The assessor is blinded to the intervention condition.
Intervention model description
This study will test the Adapt/manualize an Alcohol-targeted Brief Intervention-Medication Therapy Management (ABI-MTM) intervention compared to standard medication counseling
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* English speaking * ≥18 years * Not receiving cancer treatment * Current alcohol use * Prescribed an opioid medication
Exclusion criteria
* SA 2 exclusion * Are pregnant * Cannot provide collateral contact information for ≥2 persons * Do not have a reliable land line or mobile phone to be contacted by study staff * Are filling only buprenorphine * Plan to leave the area for an extended period of time in the next 3-months, or * Have experienced a psychotic and/or manic episode in the last 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol Use Reductions | 3 Months. Changes in alcohol use will be assessed by comparing baseline to month 2. Changes in alcohol use will also be assessed by comparing month 2 to month 3. | The investigators will use the Timeline Follow Back to assess alcohol use reductions. This measure is a calendar based assessment that captures a continuous number (counts) of days of substance use. This quantitative measure is both valid and reliable. |
| Opioid Medication Use | 3 Months. Changes in medication use will be assessed by comparing baseline to month 2. Changes in medication use will also be assessed by comparing month 2 to month 3. | The investigators will use the Treatment Services Review 6 to assess if the patients decrease their medication use. This measure is a calendar based assessment that captures a continuous number (counts) of days of substance use. This quantitative measure is both valid and reliable. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Alcohol-targeted Brief Intervention-Medication Therapy Management Alcohol-targeted Brief Intervention-Medication Therapy Management (ABI-MTM) intervention is a pharmacy-based medication management intervention, combined with Screening, Brief Intervention, and Referral to Treatment
Alcohol-targeted Brief Intervention-Medication Therapy Management: Alcohol-targeted Brief Intervention-Medication Therapy Management (ABI-MTM) intervention is a pharmacy-based medication management intervention, combined with Screening, Brief Intervention, and Referral to Treatment. ABI-MTM includes 5 core elements. A common duration for medication counseling in outpatient pharmacies a single 30-45 minute session. These include a medication review, a personal medication record, a medication action plan, a brief motivational intervention, and documentation and follow up. | 22 |
| Standard Medication Counseling Standard Medication Counseling (SMC) (1) will offer counseling, (2) document counseling was offered, (3) offer a counseling process for patients not present, and (4) discuss generic substitution. 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
Standard medication counseling: 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 selecting control conditions in behavioral intervention studies. For the first component, all SMC participants will receive a single 5-10 minute medication information/counseling session delivered by a 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 requirements 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. 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. | 22 |
| Qualitative Interviews Interviews were conducted of pharmacy technicians, pharmacists, and corporate leaders. Interviews assessed perceptions towards screening/intervention, internal organizational challenges, and processes related to ABI-MTM implementation for large-scale research and practice. | 68 |
| Total | 112 |
Baseline characteristics
| Characteristic | Alcohol-targeted Brief Intervention-Medication Therapy Management | Standard Medication Counseling | Qualitative Interviews | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 12 Participants | 0 Participants | 20 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 10 Participants | 68 Participants | 92 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants | 21 Participants | 0 Participants | 43 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 68 Participants | 68 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 68 Participants | 68 Participants |
| Race (NIH/OMB) White | 20 Participants | 22 Participants | 0 Participants | 42 Participants |
| Region of Enrollment United States | 22 participants | 22 participants | 68 participants | 112 participants |
| Sex/Gender, Customized Females | 8 Participants | 17 Participants | 36 Participants | 61 Participants |
| Sex/Gender, Customized Males | 14 Participants | 15 Participants | 26 Participants | 55 Participants |
| Sex/Gender, Customized Unknown | 0 Participants | 0 Participants | 6 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Alcohol Use Reductions
The investigators will use the Timeline Follow Back to assess alcohol use reductions. This measure is a calendar based assessment that captures a continuous number (counts) of days of substance use. This quantitative measure is both valid and reliable.
Time frame: 3 Months. Changes in alcohol use will be assessed by comparing baseline to month 2. Changes in alcohol use will also be assessed by comparing month 2 to month 3.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Alcohol-targeted Brief Intervention-Medication Therapy Management | Alcohol Use Reductions | <=19% reduction in drinks per day | 11 Participants |
| Alcohol-targeted Brief Intervention-Medication Therapy Management | Alcohol Use Reductions | 20-24% reduction in drinks per day | 1 Participants |
| Alcohol-targeted Brief Intervention-Medication Therapy Management | Alcohol Use Reductions | 25-29% reduction in drinks per day | 1 Participants |
| Alcohol-targeted Brief Intervention-Medication Therapy Management | Alcohol Use Reductions | >=30% reduction in drinks per day | 9 Participants |
| Standard Medication Counseling | Alcohol Use Reductions | >=30% reduction in drinks per day | 7 Participants |
| Standard Medication Counseling | Alcohol Use Reductions | <=19% reduction in drinks per day | 12 Participants |
| Standard Medication Counseling | Alcohol Use Reductions | 25-29% reduction in drinks per day | 2 Participants |
| Standard Medication Counseling | Alcohol Use Reductions | 20-24% reduction in drinks per day | 1 Participants |
Primary
Opioid Medication Use
The investigators will use the Treatment Services Review 6 to assess if the patients decrease their medication use. This measure is a calendar based assessment that captures a continuous number (counts) of days of substance use. This quantitative measure is both valid and reliable.
Time frame: 3 Months. Changes in medication use will be assessed by comparing baseline to month 2. Changes in medication use will also be assessed by comparing month 2 to month 3.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Alcohol-targeted Brief Intervention-Medication Therapy Management | Opioid Medication Use | 11-19% reduction in morphine milligram equivalents | 1 Participants |
| Alcohol-targeted Brief Intervention-Medication Therapy Management | Opioid Medication Use | 25-29% reduction in morphine milligram equivalents | 1 Participants |
| Alcohol-targeted Brief Intervention-Medication Therapy Management | Opioid Medication Use | 20-24% reduction in morphine milligram equivalents | 1 Participants |
| Alcohol-targeted Brief Intervention-Medication Therapy Management | Opioid Medication Use | >=30% reduction in morphine milligram equivalents | 7 Participants |
| Alcohol-targeted Brief Intervention-Medication Therapy Management | Opioid Medication Use | <=10% reduction in morphine milligram equivalents | 12 Participants |
| Standard Medication Counseling | Opioid Medication Use | >=30% reduction in morphine milligram equivalents | 4 Participants |
| Standard Medication Counseling | Opioid Medication Use | <=10% reduction in morphine milligram equivalents | 17 Participants |
| Standard Medication Counseling | Opioid Medication Use | 11-19% reduction in morphine milligram equivalents | 0 Participants |
| Standard Medication Counseling | Opioid Medication Use | 20-24% reduction in morphine milligram equivalents | 0 Participants |
| Standard Medication Counseling | Opioid Medication Use | 25-29% reduction in morphine milligram equivalents | 1 Participants |