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PloS One 2022The current research aims to systematically review the rates of adherence reported in randomised controlled clinical trials of acamprosate. It also sought to determine...
AIM
The current research aims to systematically review the rates of adherence reported in randomised controlled clinical trials of acamprosate. It also sought to determine the reliability of the adherence monitoring and measurement methods used in these trials.
METHODS
The protocol for this review was pre-registered (PROSPERO: CRD42021230011). A search of the literature was conducted using OVID MEDLINE, Embase and PsycINFO from database inception to January 2021. Randomised controlled trials with a minimum sample size of 10 per treatment arm that compared the efficacy of acamprosate with placebo or other active medication in adults with a diagnosis of alcohol dependence were included. Data on rates of adherence, methods of measurement and monitoring of adherence was extracted from eligible studies independently in duplicate by two reviewers. A weighted mean adherence rate was calculated. The reliability of adherence monitoring methods was determined by calculating an adherence-assurance score based on the adherence monitoring method used. Risk of bias was assessed using the Cochrane Risk of Bias Tool.
RESULTS
Fifteen studies met the eligibility criteria involving 4,450 participants (2,480 participants in the placebo arms). A mean adherence rate of 88% (54.2-95.0%) was reported across studies that reported the percentage of medication taken. A mean adherence rate of 84.9% (56.4-91.3%) was reported for trials that reported the percentage of participants taking more than 80% of medication prescribed. There is low confidence in the methods used to monitor adherence with all clinical trials having a low adherence-assurance rating. Risk of bias was judged to be high for all included studies.
CONCLUSIONS
Adherence to acamprosate in clinical trials can be poor with low confidence in the methods used to measure it. Adherence rates therefore might not be accurate, which has implications for determining the efficacy of acamprosate.
Topics: Acamprosate; Adult; Alcohol Deterrents; Alcoholism; Clinical Decision-Making; Humans; Medication Adherence; Middle Aged; Randomized Controlled Trials as Topic; Reproducibility of Results
PubMed: 35113930
DOI: 10.1371/journal.pone.0263350 -
Drug and Alcohol Dependence Dec 2020For people with HIV (PWH) and alcohol use disorder (AUD) who initiated behavioral treatment (BAUD) we: 1) describe BAUD intensity and medication (MAUD); and 2) examine...
BACKGROUND
For people with HIV (PWH) and alcohol use disorder (AUD) who initiated behavioral treatment (BAUD) we: 1) describe BAUD intensity and medication (MAUD); and 2) examine whether BAUD and MAUD were associated with changes in HIV-related outcomes (CD4 cell count, HIV-1 viral load [VL], VACS Index score 2.0, and antiretroviral [ARV] adherence) from before to one year after treatment initiation.
METHODS
We used Veterans Aging Cohort Study (VACS) data to describe BAUD intensity and MAUD (acamprosate, disulfiram, and naltrexone, gabapentin or topiramate). Linear regression models estimated changes in outcomes and included BAUD, MAUD, age and race/ethnicity.
RESULTS
We identified 7830 PWH who initiated BAUD from 01/2008-09/2017. Median age was 53, 60% were African-American and 28% white. BAUD intensity groups were: 1) Single Visit - 35%; 2) Minimal - 44% recieved ∼2 visits during first month; 3) Sustained Moderate - 17% recieved ∼8 visits/month initially; and 4) Intensive - 4% started out receiving ∼14-16 visits/month. Only 9% recieved MAUD, the majority of which was gabapentin. Among those with detectable VL: all HIV-related outcomes improved more among those with more intensive BAUD. Among those with undetectable VL: adherence improved more among those with greater BAUD intensity. MAUD was associated with increased CD4 among those with detectable VL and with improved adherence among both groups.
CONCLUSION
Of those with >1 BAUD visit, only 21% received at least moderate BAUD and 9% received at least 6 months of MAUD. Increasing AUD treatment intensity may improve HIV-related outcomes, especially among those with detectable VL.
Topics: Adult; Alcohol Deterrents; Alcoholism; Anti-Retroviral Agents; Cognitive Behavioral Therapy; Cohort Studies; Female; HIV Infections; Humans; Longitudinal Studies; Male; Middle Aged; Treatment Outcome; Veterans; Viral Load
PubMed: 32971391
DOI: 10.1016/j.drugalcdep.2020.108272 -
Alcoholism, Clinical and Experimental... Oct 2020One of the challenges in early-stage clinical research aimed at developing novel treatments for alcohol use disorder (AUD) is that the enrolled participants are heavy... (Randomized Controlled Trial)
Randomized Controlled Trial
Differences in Sociodemographic and Alcohol-Related Clinical Characteristics Between Treatment Seekers and Nontreatment Seekers and Their Role in Predicting Outcomes in the COMBINE Study for Alcohol Use Disorder.
BACKGROUND
One of the challenges in early-stage clinical research aimed at developing novel treatments for alcohol use disorder (AUD) is that the enrolled participants are heavy drinkers, but do not seek treatment for AUD.
AIMS
To compare nontreatment seekers with alcohol dependence (AD) from 4 human laboratory studies conducted at Brown University (N = 240; 65.4% male) to treatment seekers with AD from the multisite COMBINE study (N = 1,383; 69.1% male) across sociodemographic and alcohol-related clinical variables and to evaluate whether the variables that significantly differentiate the 2 samples predict the 3 main COMBINE clinical outcomes: time to relapse, percent days abstinent (PDA), and good clinical outcome.
METHODS
Sample characteristics were assessed by parametric and nonparametric testing. Three regression models measured the association between the differing variables and the 3 main COMBINE clinical outcomes.
RESULTS
The nontreatment seekers, compared to the treatment seekers, were more ethnically diverse, less educated, single, and working part-time or unemployed (p's < 0.05); they met fewer DSM-IV AD criteria and had significantly lower scores on alcohol-related scales (p's < 0.05); they were less likely to have a father with alcohol problems (p < 0.0001) and had a significantly earlier age of onset and longer duration of AD (p's < 0.05); they also had significantly more total drinks, drinks per drinking day, heavy drinking days (HDD), and lower PDA in the 30 days prior to baseline (p's < 0.0001 to <0.05). Having more HDD in the 30 days prior to baseline predicted all of the 3 COMBINE clinical outcomes. All the other characteristics mentioned above that differed significantly between the 2 groups predicted at least 1 of the 3 COMBINE clinical outcomes, except for level of education, age of onset, and duration of AD.
CONCLUSIONS
The observed differences between groups should be considered in efforts across participant recruitment at different stages of the development of new treatments for AUD.
Topics: Acamprosate; Adult; Age of Onset; Alcohol Deterrents; Alcoholism; Case-Control Studies; Drug Therapy, Combination; Female; Humans; Male; Naltrexone; Patient Acceptance of Health Care; Socioeconomic Factors; Treatment Outcome
PubMed: 32997422
DOI: 10.1111/acer.14428 -
Alcoholism, Clinical and Experimental... Jul 2022Data from trials of medications for alcohol use disorder (AUD) can be used to identify predictors of drinking outcomes regardless of treatment, which can inform the... (Randomized Controlled Trial)
Randomized Controlled Trial
Predictors of abstinence, no heavy drinking days, and a 2-level reduction in World Health Organization drinking levels during treatment for alcohol use disorder in the COMBINE study.
BACKGROUND
Data from trials of medications for alcohol use disorder (AUD) can be used to identify predictors of drinking outcomes regardless of treatment, which can inform the design of future trials with heterogeneous populations. Here, we identified predictors of abstinence, no heavy drinking days, and a 2-level reduction in World Health Organization (WHO) drinking levels during treatment for AUD in the Combined Pharmacotherapies and Behavioral Interventions (COMBINE) Study.
METHODS
We utilized data from the COMBINE Study, a randomized placebo-controlled trial evaluating the efficacy of naltrexone and acamprosate, both alone and in combination, for AUD (n = 1168). A tree-based machine learning algorithm was used to construct classification trees predicting abstinence, no heavy drinking days, and a 2-level reduction in WHO drinking levels in the last 4 weeks of treatment, based on 89 baseline variables.
RESULTS
The final tree for predicting abstinence had one split based on consecutive days abstinent prior to randomization, with a higher proportion of subjects achieving abstinence among those classified as abstinent for >2 versus ≤2 consecutive weeks prior to randomization (66% vs. 29%). The final tree for predicting no heavy drinking days in the last 4 weeks of treatment had three splits based on consecutive days abstinent, age, and total Alcohol Dependence Scale score at baseline. Seventy-three percent of the subjects classified as abstinent for >2 consecutive weeks prior to randomization had no heavy drinking days in the last 4 weeks of treatment. Among those classified as abstinent ≤2 consecutive weeks prior, three additional splits showed that younger subjects (age ≤44 years; 37%), and older subjects (age >44) with a total Alcohol Dependence Scale score >13 and complete abstinence (56%) or other drinking goals (35%), were less likely to have no heavy drinking days than older subjects with a total Alcohol Dependence Scale score ≤13 (67%). The final tree for predicting a 2-level reduction in WHO levels had no splits.
CONCLUSIONS
Consecutive days abstinent prior to randomization may predict abstinence and no heavy drinking days and total Alcohol Dependence Scale score and age may predict no heavy drinking days. The 2-level reduction in WHO levels outcome may be less likely to discriminate based on multiple patient characteristics.
Topics: Adult; Alcohol Abstinence; Alcohol Drinking; Alcoholism; Humans; Naltrexone; Treatment Outcome; World Health Organization
PubMed: 35616436
DOI: 10.1111/acer.14877 -
Current Neuropharmacology 2020Pharmacological treatment for alcohol dependence has only three approved drugs: disulfiram, naltrexone and acamprosate. The effects of these drugs are, however, limited,...
BACKGROUND
Pharmacological treatment for alcohol dependence has only three approved drugs: disulfiram, naltrexone and acamprosate. The effects of these drugs are, however, limited, presenting several side effects and a modestly higher efficacy compared to placebo. The administration of omega-3 might bring new perspectives to relapse prevention.
METHODS
This systematic review aimed to analyze the available literature, compiling the studies that used omega-3 to prevent relapse in alcohol dependents.
RESULTS
The databases used were PubMed and Web of Science. We identified 2,231 studies and only five articles addressed the administration of omega-3 and alcoholism. Preclinical studies evaluating the effects of PUFAs related to chronic alcohol administration showed improvements in behavioral, cellular and molecular levels. The clinical trial yielded inconclusive results.
CONCLUSION
Despite the reduced number of studies, omega-3 interventions seem to be promising for controlling issues related to alcohol dependence.
Topics: Alcoholism; Animals; Behavior, Animal; Clinical Trials as Topic; Fatty Acids, Omega-3; Humans; Secondary Prevention; Treatment Outcome
PubMed: 31989899
DOI: 10.2174/1570159X18666200128120729 -
The Mental Health Clinician Aug 2022At a Veterans Affairs Medical Center (VAMC), a clinical pharmacist practitioner (CPP) was added to an inpatient addiction triage team in August 2019 to provide education...
INTRODUCTION
At a Veterans Affairs Medical Center (VAMC), a clinical pharmacist practitioner (CPP) was added to an inpatient addiction triage team in August 2019 to provide education and recommendations regarding medications for alcohol use disorder (MAUD) and opioid use disorder (MOUD). Before the addition of the CPP, missed opportunities for MAUD and MOUD education and prescribing prior to discharge on non-psychiatric units were observed.
METHODS
This was a single-center, single-site, retrospective, observational cohort study with a primary objective to compare initiation rates of MAUD/MOUD 12 months before and after the addition of the CPP to the addiction triage team. Secondary end points included 90-day medication possession ratio, 1- and 3-month emergency department visit rates, 1- and 3-month hospital readmission rates, and opioid education and naloxone distribution interventions for eligible patients with a diagnosis of opioid use disorder.
RESULTS
Both statistically and clinically significant improvements in MAUD/MOUD initiation rates were found in the CPP intervention group compared with the historical control group (26.3% vs 4%, < .0001). Although secondary end points within this review were not found to be statistically significant, improvements were seen in the CPP intervention group compared with the historical control group related to medication possession ratio, and emergency department and hospital readmission rates.
DISCUSSION
This study highlights the potential utility of a CPP to an inpatient addiction triage team to improve MAUD/MOUD prescribing rates in appropriate patients prior to discharge. Overall, the introduction of a CPP to an inpatient addiction triage team was feasible, well received by interprofessional team members, and required limited additional resources.
PubMed: 36071740
DOI: 10.9740/mhc.2022.08.219 -
Indian Journal of Pharmacology 2021
Topics: Acamprosate; Adult; Alcohol Deterrents; Alcoholism; Diagnosis, Differential; Electroencephalography; Humans; Male; Myoclonus
PubMed: 34975141
DOI: 10.4103/ijp.ijp_386_21 -
Addiction Science & Clinical Practice May 2024Alcohol-attributable medical disorders are prevalent among individuals with alcohol use disorder (AUD). However, there is a lack of research on prescriptions of...
BACKGROUND
Alcohol-attributable medical disorders are prevalent among individuals with alcohol use disorder (AUD). However, there is a lack of research on prescriptions of pharmacological treatment for AUD in those with comorbid conditions. This study aims to investigate the utilization of pharmacological treatment (acamprosate, disulfiram and naltrexone) in specialist care among patients with AUD and comorbid medical diagnoses.
METHODS
This was a descriptive register-based Swedish national cohort study including 132,728 adults diagnosed with AUD (N = 270,933) between 2007 and 2015. The exposure was alcohol-attributable categories of comorbid medical diagnoses. Odds ratios (OR) were calculated using mixed-effect logistic regression analyses for any filled prescription of acamprosate, disulfiram or oral naltrexone within 12 months post AUD diagnosis.
RESULTS
Individuals with comorbid alcohol-attributable medical diagnoses had lower odds of filling prescriptions for any type of AUD pharmacotherapy compared to those without such comorbidities. Cardiovascular (OR = 0.41 [95% CI: 0.39-0.43]), neurological (OR = 0.52 [95% CI: 0.48-0.56]) and gastrointestinal (OR = 0.57 [95% CI: 0.54-0.60]) diseases were associated with the lowest rates of prescription receipt. The presence of diagnoses which are contraindications to AUD pharmacotherapy did not fully explain the low prescription rate.
CONCLUSION
There is a substantial underutilization of AUD pharmacotherapy in patients with AUD and comorbid medical disorders in specialist care. Increasing the provision of pharmacotherapy to this group of patients is essential and may prevent morbidity and mortality. There is a need to further understand barriers to medical treatment both from the patient and prescriber perspective.
Topics: Humans; Sweden; Female; Male; Disulfiram; Middle Aged; Alcohol Deterrents; Adult; Comorbidity; Alcoholism; Acamprosate; Naltrexone; Aged; Cohort Studies; Registries; Young Adult
PubMed: 38764075
DOI: 10.1186/s13722-024-00471-9 -
Drug and Alcohol Review Nov 2023Alcohol dependence is a chronic condition impacting millions of individuals worldwide. Safe and effective medicines to reduce relapse can be prescribed by general... (Randomized Controlled Trial)
Randomized Controlled Trial
INTRODUCTION
Alcohol dependence is a chronic condition impacting millions of individuals worldwide. Safe and effective medicines to reduce relapse can be prescribed by general practitioners but are underutilised in the general Australian population. Prescription rates of these medicines to Aboriginal and Torres Strait Islander (First Nations) Australians in primary care are unknown. We assess these medicines in Aboriginal Community Controlled Health Services and identify factors associated with prescription.
METHODS
Baseline data (spanning 12 months) were used from a cluster randomised trial involving 22 Aboriginal Community Controlled Health Services. We describe the proportion of First Nations patients aged 15+ who were prescribed a relapse prevention medicine: naltrexone, acamprosate or disulfiram. We explore associations between receiving a prescription, a patient AUDIT-C score and demographics (gender, age, service remoteness) using logistic regression.
RESULTS
During the 12-month period, 52,678 patients attended the 22 services. Prescriptions were issued for 118 (0.2%) patients (acamprosate n = 62; naltrexone n = 58; disulfiram n = 2; combinations n = 4). Of the total patients, 1.6% were 'likely dependent' (AUDIT-C ≥ 9), of whom only 3.4% received prescriptions for these medicines. In contrast, 60.2% of those who received a prescription had no AUDIT-C score. In multivariate analysis, receiving a script (OR = 3.29, 95% CI 2.25-4.77) was predicted by AUDIT-C screening, male gender (OR = 2.24, 95% CI 1.55-3.29), middle age (35-54 years; OR = 14.41, 95% CI 5.99-47.31) and urban service (OR = 2.87, 95% CI 1.61-5.60).
DISCUSSION AND CONCLUSIONS
Work is needed to increase the prescription of relapse prevention medicines when dependence is detected. Potential barriers to prescription and appropriate ways to overcome these need to be identified.
Topics: Humans; Male; Middle Aged; Acamprosate; Australia; Australian Aboriginal and Torres Strait Islander Peoples; Chronic Disease; Disulfiram; Health Services, Indigenous; Naltrexone; Secondary Prevention; Adult; Alcoholism
PubMed: 37422892
DOI: 10.1111/dar.13708 -
PloS One 2021Update the evidence on use of pharmacotherapy for alcohol use disorder in a Canadian population.
OBJECTIVE
Update the evidence on use of pharmacotherapy for alcohol use disorder in a Canadian population.
METHODS
Using whole-population administrative data from Manitoba, Canada, we identified all residents age 12+ who were first diagnosed with alcohol use disorder between April 1, 1996 and March 31, 2015, and compared characteristics of those who filled a prescription for naltrexone, acamprosate or disulfiram at least once during that period to those who did not fill a prescription for an alcohol use disorder medication.
RESULTS
Only 1.3% of individuals with alcohol use disorder received pharmacotherapy (62.3% of prescriptions were for naltrexone, 39.4% for acamprosate, 7.5% for disulfiram). Most prescriptions came from family physicians in urban alcohol use disorder (53.6%) and psychiatrists (22.3%). Individuals were more likely to fill a prescription for alcohol use disorder medication if they lived in an urban vs rural environment (OR 2.25; 95% CI 1.83-2.77) or had a mood/anxiety disorder diagnosis vs no diagnosis (OR 2.40, 95% CI 1.98-2.90) in the five years before being diagnosed with alcohol use disorder.
CONCLUSION
Despite established evidence for the effectiveness of pharmacotherapy for alcohol use disorder, these medications continue to be profoundly underutilized in Canada.
Topics: Acetaldehyde Dehydrogenase Inhibitors; Adolescent; Adult; Aged; Alcohol Deterrents; Alcoholism; Canada; Child; Cohort Studies; Female; Humans; Male; Middle Aged; Narcotic Antagonists; Young Adult
PubMed: 34478448
DOI: 10.1371/journal.pone.0257025