Patient Perspectives on Pharmacotherapy of Alcohol Dependence

• Abstract
• Introduction
• Materials and Methods
• Results
• Discussion
• Limitations
• Conclusion
• Contributor's Statement
• References

Abstract

Introduction Pharmacotherapy with drugs like naltrexone or acamprosate is a well-evaluated element in the treatment of alcohol dependence (AD). However, in many countries, these medications are rarely administered. The objective of the present study was to identify from patients’ perspective factors that prevent the initiation and compliance with pharmacological treatment of AD.

Methods Patients from inpatient alcohol withdrawal treatment underwent a standardized interview. Questions included socio-demographic data, history of AD, treatment history, knowledge and personal experience regarding pharmacotherapy of AD, and personal views about the causes of AD.

Results Three hundred patients (mean age 47.3 years, 27.7% female, mean duration of AD 8.9 years, 67% with a history of previous inpatient withdrawal treatment) were included. The majority of patients (58.7%) already knew drugs for the pharmacotherapy of AD. Thirty percent had ever used such medications, most often acamprosate. Except for disulfiram, pharmacotherapy of AD had lasted only a few weeks, on average. Medication usually had been applied without additional psychotherapy. No severe side effects were reported. Patients had often stopped pharmacotherapy on their own, when assuming they had reached stable abstinence. Openness to start pharmacotherapy for AD was currently stated by 67% of the total sample. In multiple logistic regression, openness was predicted by having a concept of AD as a medical disease and by a shorter duration of AD.

Discussion To improve the administration of pharmacotherapy for AD implementation strategies should be systematically developed and evaluated with a focus on the concept of AD as a medical disease.

Introduction

Alcohol dependence (AD) is a severe mental disorder with a chronic, relapsing course [1]. Abstinence-oriented treatment of alcohol dependence includes several elements, such as withdrawal treatment, relapse prevention training, treatment of comorbid mental disorders, and rehabilitation treatment. Treatment may also include pharmacotherapy of AD, which has to be distinguished from medication for the treatment of withdrawal symptoms. Four approved medications play a notable role in the treatment of alcoholism in Europe [2] [3]. Disulfiram blocks the conversion of acetaldehyde (itself converted from alcohol) into acetic acid, resulting in an upsurge of acetaldehyde. In the case of alcohol consumption during disulfiram treatment, acetaldehyde will induce adverse reactions. Patients, therefore, abstain from the ingestion of alcohol to prevent these negative consequences. Acamprosate, a glutamate system modulator, is prescribed to maintain abstinence and reduce alcohol craving; however, its mechanism is unclear. Naltrexone is a μ-receptor-antagonist that reduces the opioid-mediated rewarding effects of alcohol. Its main effect relates to the reduction of alcohol consumption in relapse. Nalmefene is also a μ-receptor-antagonist.

Meta-analyses and systematic reviews of randomized controlled trials confirmed that acamprosate and naltrexone are effective compared with placebo in maintaining alcohol abstinence after withdrawal treatment and reducing the amount of alcohol consumed after relapse [3] [4] [5]. There is also evidence that treatment with these medications is effective in non-selected patient populations in real-world settings [6]. The evidence regarding disulfiram is equivocal. Due to the induction of adverse reactions to alcohol, placebo-controlled studies are difficult to conduct. In addition, there seems to be a huge impact of the setting of disulfiram treatment, especially the supervision of intake of disulfiram, on treatment outcomes [7].

Rates for pharmacotherapy of AD are often low, though. In the USA, for example, only 1.6% of all adults with AD, or less than 10% of patients who undergo any form of AD treatment, receive pharmacotherapy [8] [9], although guidelines suggest that patients with AD should be prescribed pharmacotherapy among other interventions. Sample data from the statutory health insurance in Germany showed that only 2.2% of AD patients had ever received medications for the pharmacotherapy of AD, and within 6 months after inpatient alcohol withdrawal treatment, only 0.8% had received these medications [10]. In contrast, about 22% of AD patients in Sweden receive pharmacotherapy [11].

Barriers to utilization of pharmacotherapy have been studied primarily from the perspective of treatment providers. They included physicians’ lack of knowledge of these medications and associated training needs, doubts about effectiveness, a perceived lack of interest from the patient side [12] [13] [14] [15] [16], AD-related stigma, and treatment philosophies conflicting with a pharmacological approach [14].

There is still a lack of knowledge about obstacles and barriers to the utilization of pharmacotherapy from the perspective of persons with AD, particularly of patients in AD treatment. In the present cross-sectional study, alcohol-dependent patients undergoing inpatient withdrawal treatment report their knowledge of pharmacotherapy of AD, their own experiences with such treatment, reasons for denying such a treatment, and their openness to start a pharmacotherapy of AD. In addition, openness to pharmacotherapy will be related to possible influencing factors such as patient history, experiences with previous pharmacotherapy of AD, and personal concepts of the nature of AD.

Materials and Methods

The present study was carried out in an inpatient ward for detoxification treatment at the LVR-Klinikum Bonn, a psychiatric hospital in a city of 330, 000 citizens. Comprehensive withdrawal treatment for AD includes medical treatment to relieve alcohol withdrawal symptoms, the diagnosis of comorbid somatic and mental disorders, and motivational interventions to assist patients to start a follow-up treatment after withdrawal treatment. Follow-up treatment might consist of comprehensive outpatient treatment, including pharmacotherapy of AD or inpatient rehabilitation treatment.

All patients admitted during a 9-month period from June 2018 to March 2019 were considered for participation. Inclusion criteria were alcohol dependence according to ICD-10 (F10.2) as the main diagnosis; age at least 18 years; voluntary treatment; and written informed consent for study participation. Exclusion criteria were current psychotic disorder, severe cognitive deficits, severe withdrawal symptoms, language barriers, and length of inpatient stay of less than 3 days. Patients who were repeatedly admitted during the observation period were included only once.

Participants were interviewed for the study at least 3 days after admission. The interview was developed specifically for the present study and contained standardized questions. It was based in part on the European Addiction Severity Index [17], e. g., regarding questions about substance use or treatment history. Questions about concepts and attitudes regarding alcohol dependence were adapted from the “Public Attitudes to the Disease Concept of Alcoholism questionnaire” [18]; with permission from the authors, the items were translated into German, and then an independent back-translation was performed by two persons fluent in English, to control for faithfulness to the original. The duration of the interview was about 35 minutes. No validation study was carried out with the final version of the complete interview. Patients indicated their agreement to statements about the nature and the etiology of AD on a 5-point scale; items were differentiating especially between concepts of AD as an illness or a mental disorder versus the result of psychosocial problems.

Knowledge of AD medication in general and personal treatment experience with specific medications (acamprosate, disulfiram, naltrexone, and nalmefene were labeled with their generic names and the most common trade names) was recorded using questions developed for this survey. We included only those four substances recommended by the German guidelines for alcoholism treatment [19]. In the 4-level recommendation scheme, acamprosate and naltrexone are rated as level “B” (Empfehlung [Recommendation]), Disulfiram as level “O” (offen [open]), all based on empirical evidence, while nalmefene is recommended as good clinical practice, based on clinical consensus. Substances not mentioned in the guidelines or those advised against (such as baclofen) were not included here.

Patients were informed that drugs for relief of acute alcohol withdrawal symptoms, such as clomethiazole (e. g., Distraneurin) or clonazepam (e. g., Rivotril), were not the subject of the questionnaire. Patients were also asked whether they were interested in using any such medication. During a pilot phase, the questionnaire was administered to five patients and checked for comprehensibility. The study interviews were carried out by a specialized physician (CW).

The primary outcome of the present study is patients’ openness to the pharmacotherapy of alcohol use disorders, which will be analyzed by multiple binary logistic regression with patient characteristics as predictors, including disease history, treatment history, personal opinion about the nature of AD, and socio-demographic variables.

Significance criterion throughout this study was p<0.01, to limit the risk of type I errors in the face of multiple testing while maintaining sufficient statistical power. The statistical software used was SPSS version 25 (IBM Corporation).

The study was approved by the Ethics Committee of the University Hospital of Essen, Germany (18–7966-BO). The study was registered at the German Clinical Trials Register (DRKS00013881).

Results

Of 316 alcohol-dependent patients fulfilling inclusion criteria, n=5 were discharged during the first 2 days of treatment, n=7 refused to participate, and n = 4 were excluded for other reasons. The socio-demographic characteristics and medical history of the remaining 300 participants are summarized in [Table 1]. The study group was predominantly male, with a mean age of 47 years. About two-thirds had attained a medium or higher educational level. Among those not retired, the unemployment rate was 44.5%. About 80% were diagnosed with an additional (not substance-related) mental disorder; half of the sample suffered from depressive disorders.

One or more types of medication for AD were known to 58.7% of the patients (n=176) ([Fig. 1]). The substance most widely known was disulfiram (e. g., Antabus), with 55.7% (n=167) having “already heard of it”, followed by acamprosate (e. g., Campral) with 49% (n=147), naltrexone with 21.4% (n=64) and nalmefene with 8.7% (n=26), respectively. The type of treatment received in the past was of importance here. Of those with previous inpatient detoxification treatment but no rehab treatment, 31.3% reported of having been informed by treatment staff about one or more medications. In contrast, of those patients with previous comprehensive detoxification treatment plus rehabilitation treatment, 85.3% reported of having been informed. This difference was statistically significant (p<0.001, Chi-square test). In total, 217 such educations or discussions were reported, of which 90 (41.5%) had resulted in a prescription; in 112 (51.6%) instances, the patient had denied the prescription, and in 15 (6.9%) instances, the physician had refrained from a prescription.

Less than half of the patients (46.4%) had ever been offered pharmacological treatment for AD, and only 22.0% had ever taken any such medication (acamprosate 16.0%, disulfiram 7.0%, naltrexone 5.3%, and nalmefene 1.7%). History of pharmacological treatment was associated with other forms of AD treatment ([Table 2]): Only 1 out of 99 patients who had not received any specific AD treatment had previously taken AD medication, compared with 17.2% (17 out of 99) of those who had comprehensive inpatient withdrawal treatment, and 47.1% (48/102) with previous comprehensive inpatient detoxification treatment plus rehabilitation treatment. The three pairwise group differences were statistically significant (p<0.001, Chi-square test).

The mean treatment duration with acamprosate was 85 days (SD 113), 104 (SD 108) days with naltrexone, 35 (SD 20) days with nalmefene, and 323 days (SD 488) with disulfiram ( [Table 3]). While the majority of patients with pharmacological treatment of AD had been offered additional psychotherapy, only a minority had attended such treatment (acamprosate 11 out of 48 [23%], disulfiram 7 out of 21 [33%], naltrexone 9 out of 16 [56%], nalmefene 0 out of 5). Those with additional psychotherapy (n=27) had remained significantly longer in pharmacological treatment of AD (mean 237 days, SD 185) than those (n=63) without psychotherapy (mean 100 days, SD 192; p=0.009, Welch-corrected t-test). For the vast majority of previous pharmacotherapy of AD, no side effects of medications were reported. The majority of patients with previous pharmacotherapy endorsed the statement that the drugs successfully reduced cravings. All terminations of previous pharmacotherapy had been initiated by the patients, according to self-report, and none because the treating physician stopped the prescription. Reasons for termination of pharmacotherapy from patients´ perspective included the belief that they were able to stay abstinent without further intake of the respective medication (42 out of 90 treatments, 46.7%) and relapse to alcohol use (35 out of 90, 38.9%).

N=75 patients had previously refused the offer of relapse-preventing medication. As can be seen in [Fig. 2], the most important reason for this had been “not having been informed enough about pharmacotherapy of AD” (e. g., 64.0% with a response of 6 or 7 points on a scale ranging from 1 to 7), “hopelessness with regard to curability of their AD” (58.7%), and “fear of side effects” (44.0%). The responses to these three questions did not differ significantly (sign tests, all p>0.1). In addition, a large subgroup was “generally skeptical about medications” (26.7%). Other reasons played only a marginal role.

Using the Public Attitudes to the Disease Concept of Alcoholism Questionnaire [18], four concepts of alcohol dependence were presented to participants. The highest rate of agreement (defined as 4 or 5 points on the rating scale) was with the statement “alcohol dependence is a kind of disease” (61.0%). The agreement was markedly lower with “…is a kind of misconduct” (37.3%), “…can best be seen as some kind of drug addiction like heroin addiction (34.9%), and “…is a kind of habit, not a disease (27.8%). For the five suggested causes for alcohol dependence, rates of agreement were (in descending order) “People become alcoholics because of unhappiness with their life, marriage or job” (82.0%), “The cause of alcoholism is in the physical makeup some people are born with” (62.4%), “The causes of alcoholism are more in the body than in the mind” (43.7%), “People become alcoholics because they have weak, inadequate personalities” (27.5%), and “People become alcoholics because of moral weakness” (23.4%).

Through the interviews, those patients previously unaware of pharmacotherapy of AD received information about this treatment option. Therefore, it was possible to ask all participants whether they were open to pharmacological treatment of their alcohol dependency, if sufficiently informed. N=189 (63.0%) patients answered “yes”, and N=108 (37.0%) answered “no”. Using multiple logistic regression analysis, openness to AD medication was predicted by a model including socio-demographic characteristics (age, gender, duration of school education, current employment); duration of AD; experience with medical AD treatment; experience with AD medication (no experience, positive experience, negative or mixed experience, e. g. due to side effects); pre-existing knowledge about AD medication; and concept of AD as a disease (a summary of the item “alcohol dependence is a disease“ and the inverted item “alcohol dependence can best be seen as a habit, not a disease“ [18]) ([Table 4]). The number of 11 predictors or predictor levels, respectively, corresponded with the common rule that 10 events per predictor should be available in the smaller outcome group [20].

The multiple logistic regression model as a whole showed a strong relationship with “openness to pharmacotherapy” (Nagelkerke’s pseudo-R-square=0.87). Of the single predictors, a statistically significant association with openness was seen with (shorter) duration of AD and with (higher) degree of agreement with the concept of AD as a disease.

Bivariate associations between openness for pharmacotherapy of AD and its statistically significant predictors were large in the present sample. Patients who were open to pharmacotherapy had a mean of 8.4 points (SD 1.3, median 9 points) on the 10-point sum scale for “alcohol is a disease”, while those not open had a mean of 4.9 (SD 1.7, median 5 points). Patients who were open to pharmacotherapy reported 4.7 years duration of AD, on average (SD 3.9, median 3.5 years), compared with 16.0 (SD 6.6, median 15 years) for patients not open to pharmacotherapy.

Discussion

German treatment guidelines recommend pharmacological treatment of alcohol dependence [19]. In the present study, as in previous studies [10], only a minority of alcohol-dependent patients in specialized detoxification wards in a psychiatric hospital had ever been in such a pharmacological treatment. The present study aims at the elucidation of reasons for the low use of such medication from the perspective of patients. Patients investigated here had a long history of AD, on average, a high unemployment rate, were often divorced and without a current relationship, and four out of five patients were diagnosed with a concomitant mental disorder, often with major depression. The present sample was very similar to other studies on samples in detoxification treatment, with regard to mean age and gender distribution (f: m 1: 2.6) [10] [21] The age cut-off of our study was 65 years, as patients beyond 64 years of age were treated in the gerontopsychiatric department at the same hospital. In our study, the educational status was higher than in the mentioned studies, and the percentage of unemployed participants was lower.

Only about half of the sample had been aware of pharmacological treatment options for AD before the interview. Awareness was strongly associated with previous AD treatment experience (about 2/3 of the total sample), especially for those with previous specialized withdrawal treatment, and even more for patients with previous rehabilitation treatment. This is not surprising since the education of patients on treatment options is an element of AD treatment.

However, only a minority (22%) of patients had ever actually received any pharmacological treatment of AD. The discrepancy between education on pharmacological treatment of AD and actual prescriptions was mostly caused by patients’ refusal of these options, much less by the refusal of the treating physician. This might indicate that contraindications for certain treatments (such as liver cirrhosis) played no significant role here.

The 22% rate might still appear relatively high, as only a few centers in Germany use disulfiram in specialized settings. Many patients, though, had a long history of AD and its treatment, possibly in several different settings, and therefore, the probability of receiving such medication over the course of their illness increased. In addition, the study hospital offered a “maintenance of alcohol abstinence” program, including Disulfiram medication, which some study patients had probably used in the past.

Pharmacological treatment of AD lasted only a few months, on average, despite the fact that alcohol dependence is a chronic relapsing disease. Although accompanying psychotherapy is considered obligatory in the pharmacological treatment of AD according to the official license for these drugs in Germany, only a minority attended such treatment. In the present sample, economic reasons do not prevent the pharmacotherapy of AD, as the treatment with acamprosate, naltrexone, and nalmefene (and, until a few years ago, disulfiram) is covered by the statutory health insurance in Germany. Therefore, the low rate of pharmacotherapy of AD in Germany is not related to the cost of treatment for patients, which has been shown to be a relevant barrier within the context of some other healthcare systems [22]. The reasons why only a few patients during previous pharmacological AD treatment had received additional psychotherapy was not investigated here. Possible reasons might be the unavailability of psychotherapy for patients with AD or patients’ lack of belief in the importance of psychotherapy as an element of comprehensive outpatient treatment of AD.

A subgroup of patients (n=75) was identified who had already explicitly denied the offer of pharmacological treatment of AD in the past. Those patients reported a large degree of hopelessness with regard to the prognosis of their AD, feelings that they had not been informed enough about pharmacological treatment, and fear of side effects. Here, an improvement in patient education on their treatment possibilities could improve the acceptance of and compliance with the pharmacological treatment of AD.

About 2/3 of the present sample were open to pharmacological treatment of AD. In a multiple regression analysis, this was not predicted by history of specialized AD treatment, pre-existing knowledge of pharmacological treatment, or whether patients had previously received pharmacological treatment or the outcome of that treatment, also not by gender, age, length of school education, or current employment. There were strong associations with patients’ degree of agreement with the idea that AD is a disease and not a habit and with the duration of AD. Patients with long-lasting alcohol dependency (M=16 years) were more skeptical regarding pharmacological treatment than those with shorter duration of AD (M=4.7 years). Duration of AD is a “carrier” variable, which contains, for example, more lifetime AD treatments (the rank correlation between AD duration and number of qualified withdrawal treatments was 0.62 in the present sample) and more abstinence periods, followed by relapses to alcohol use. Such experiences are hypothesized to cause more skepticism towards existing or new approaches to AD treatment and less self-efficacy expectations.

The attribution style of patients concerning their alcohol dependency relates to their openness towards a pharmacological treatment approach: the more patients were attributing externally (AD as a disease), the more they were open-minded toward pharmacotherapy of their AD. This corresponds to findings that patients with major depression who attributed their disease to external (including biological) causes, expressed stronger belief in the efficacy of antidepressant medication [23].

The present study shows that alcohol-dependent patients felt insufficiently informed about the possibilities of pharmacotherapy for AD. Patients who underwent only an inpatient medical detoxification outside a psychiatric hospital were significantly less well informed (7.1% were informed) about pharmacological treatment options for their AD than patients who had undergone a comprehensive detoxification treatment in a psychiatric hospital (64.6% were informed). Of those patients who had never attended any alcohol withdrawal treatment, only 2.2% were informed. Increased knowledge of physicians in charge of detoxification in somatic hospital departments, such as internal medicine or emergency medicine, or a closer connection with psychiatric services, could perhaps improve the start of a pharmacological treatment of AD.

Research from industrialized countries shows that only a minority of people with alcohol use disorder use specialized treatment, particularly if the disorder is not severe and problem awareness is lacking [24]. Heavier drinking patterns, a higher level of psychiatric comorbidity, or other problems directly attributable to alcohol use are associated with increased AD treatment utilization [25] [26].

Pharmacological treatment of AD, in particular, can be easily and safely provided even in the primary care setting, and utilization of this treatment option can be increased if offered in the context of high-intensity interventions [27]. Therefore, the low rate of pharmacotherapy for AD, even in those patients with AD-specific treatment experience, is of concern but has very rarely been studied from the patient perspective. One major barrier appears deficits in knowledge about pharmacotherapy options and how they may improve outcomes [28].

In a focus group study on barriers to the use of naltrexone as relapse prevention medication with AD patients in recovery [29], participants reported that they were not generally unwilling to take medications to treat alcoholism and identified a lack of information about naltrexone as a major barrier to its adoption. In addition, side effects, cost, mode of administration, and philosophy of Alcoholics Anonymous were mentioned as possible barriers.

In a qualitative interview study with alcohol-dependent US veterans, those with pharmacotherapy experience were mostly satisfied (12/15). Half of those without pharmacotherapy experience (8/15) were unconditionally willing to use it, some (6/15) expressed reservations because of concerns about side effects/drug interactions or because of a belief that their condition was not sufficiently severe, and only one patient rejected it completely [30]

Thus, findings from the present study confirm the prominent role of information and education in the initiation of pharmacological AD treatment.

Limitations

All participants were inpatients at one psychiatric hospital; hence, the results might not be generalized without caution to a larger in- and outpatient population. However, the sample investigated was similar to samples in other studies with alcohol-dependent patients in inpatient treatment in psychiatric hospitals in Germany regarding age, sex, school education, stable partnership, employment, psychiatric comorbidity, and treatment experience [31] [32]. Nevertheless, the urban structure of the recruitment area might influence the results. It may be possible that the results of a sample recruited in more rural regions would differ significantly, e. g., if rural residents with AD show different drinking patterns or are less likely to receive treatment, including pharmacotherapy of AD.

A major part of the data was based on personal views of the patients, personal assessments, and estimates. Therefore, the answers of patients might be influenced by social desirability and memory distortion. However, we feel that such factors do not invalidate the main results of the study, such as the still too little information about pharmacological treatment of AD, or the limited quality of treatment with such medication.

Conclusion

The present study shows a low rate of previous pharmacological treatment of alcohol dependency in a sample of patients with a long average duration of AD. Many patients had not already been aware of the existence of such pharmacological treatment options despite the vast majority had been in medical treatment for AD in the past. Furthermore, previous pharmacological treatment had usually not been carried out in accordance with treatment guidelines, which require accompanying psychotherapy, and treatment duration had typically been just a few months.

Providers of treatment for AD should therefore inform routinely and comprehensively patients about pharmacological treatment options, including the need for accompanying psychotherapy or counseling and the long-term duration of such a treatment. Patients who feel hopeless about overcoming their AD and those patients with a long duration of AD will possibly require particular efforts to encourage them to undergo pharmacological treatment.

Contributor's Statement

None

Conflict of Interest

The authors declare that they have no conflict of interest.

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Correspondence

Publication History

Received: 31 May 2023
Received: 20 September 2023

Accepted: 29 September 2023

Article published online:
05 December 2023

© 2023. Thieme. All rights reserved.

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

• References

• 1 Carvalho AF, Heilig M, Perez A. et al. Alcohol use disorders. Lancet 2019; 394: 781-792
  CrossrefPubMedSearch in Google Scholar
• 2 Soyka M, Kranzler HR, Hesselbrock V. et al. Guidelines for biological treatment of substance use and related disorders, part 1: Alcoholism, first revision. World J Biol Psychiatry 2017; 18: 86-119
  CrossrefPubMedSearch in Google Scholar
• 3 Kranzler HR, Soyka M. Diagnosis and pharmacotherapy of alcohol use disorder: A review. JAMA 2018; 320: 815-824
  CrossrefPubMedSearch in Google Scholar
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  CrossrefPubMedSearch in Google Scholar
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