Alcohol use and dependence is major contributor to global morbidity. It results in a multitude of risks and morbidities which include liver disease, cancer, accidents, and intentional injury. While psychosocial treatment strategies have been the most popular, there is only a limited success rate. Long term benefits who do respond to psychosocial therapy are hard to maintain. In other words, what is considered success in the treatment of alcoholism has a low standard that is measured in harm reduction or time spent sober, rather than a cure for the dependence. Pharmacological treatment using baclofen, also sold under the brand name Lioresal, is therefore of great interest in changing alcohol use behaviors. The purpose of this paper is to discuss the disease management of addiction to alcohol using baclofen, a pharmacological therapy, the effects of the medication, and the implications for advanced nursing practice.
Alcohol dependence, or alcohol use disorder (AUD), is defined as regular use of alcohol with clinical impairment of functioning. A specific checklist of authoritative clinical criteria is contained in the fifth edition of the Diagnostic and Statistical Manual for Mental Disorders (DSM-5). AUD is a disease without a cure. Cessation is possible, but relapse and a return to drinking is a constant challenge. estimates globally. Mosoni et al. (2018) estimated AUD had an incidence rate of 13.9% of the general American population. The lifetime prevalence across this population was 29.1%. Prevalence was generally higher for men than women. While generally lower for married persons and minorities, Native Americans presented a different profile. Low income predicted higher risks of AUD, and the effect was strengthened by the depth of poverty. Less than 20% of respondents indicating AUD in their lifetime had received any kind of treatment.
Neurological aspects of addiction
As Sjoerds et al. (2017) and others have described, one of the recent findings in neuroscience has been the relationship between all forms of addiction, and the restructuring of the brain at the neurological level. This is hypothesized to lead to resistance of any challenges to the addiction. The brain imaging of alcoholic patients tends to show cerebral atrophy in specific sections of the brain. It appears that on a biophysiological level addiction is able to reinforce itself through neural reorganization, but this is not conclusive, nor is the application of these findings. The research continues.
Baclofen is a selective γ-aminobutyric acid (GABA)-B receptor agonist with evidence of practical value in treatment for alcohol dependence. The primary purpose of baclofen is as a muscle relaxant that provides some relief of spasticity causing pain, such as in spinal cord injury and multiple sclerosis. Typical treatment is delivered orally, two to three times per day. New treatment options include intrathecal device implants that ensure perfect medical adherence. Adherence to the medication schedule is critical to the success of the pharmacological treatment for muscle spasticity. In relation to AUD therapy, the results are not as clear. The highest abstinence rates have been achieved through the use of psychosocial therapy in combination with a pharmacological treatments like baclofen. The problem remains that this success rate, while higher than other approaches, remains dismally low.
Possible adverse effects
Side effects can include:
- mood changes,
- impairment of visuomotor learning, and
- addiction to baclofen.
Symptoms of overdose include shallow breathing, seizures and losing consciousness. Cessation of baclofen can result in withdrawal which has serious side effects that include possible fatal acute events.
Baclofen not effective for patients who have not stopped drinking alcohol
Minozzi and fellow researchers (2018) sought to determine, through meta-analysis of existing studies, whether baclofen had a positive effect for patients who were still drinking. Just twelve studies were found at the random controlled trial level, with a total sample of 1,128 participants in eight countries. The researchers noted that the mean length of time for baclofen intervention was 150 days, and dosage varied widely from 10 mg to 150 mg per day. Findings of importance included a lack of statistical difference between baclofen and placebo groups in relation to risk of ceasing treatment or relapse. There was moderate evidence that the experimental group had slightly higher number of drinks on days that they did drink. They concluded that there was little evidence to support the use of baclofen before patients had actually stopped drinking.
Non-prescribed uses of baclofen
A further issue of note is the use of baclofen as a street drug for self-management of non-prescription drug withdrawal (Floyd, Wood & Dargan, 2018). Baclofen can be ordered online, and in many jurisdictions, there are few regulatory impediments to this practice, despite the dangers posed by self-prescribing this powerful drug.
Criticism of baclofen
Some researchers have criticized the use of baclofen by claiming that the main positive effects are achieved by sedation. It is difficult to come to evidence-based conclusions. On one hand, there is a critical need for a way to support the maintenance of abstinence in patients with AUD. On the other hand, there is compelling evidence that baclofen is not achieving the goal of alcohol independence for these paitents. The drug itself presents many risks for the patient. The evidence is, unfortunately, uncertain, and inconsistent. An issue in comparability of studies is the dosage, which typically ranges from 30 mg to almost 300 mg of baclofen daily. A study by Müller and colleagues, (2015), found a significant positive effect for maintaining abstinence at high-doses that was nearly twice that of the placebo group. This would seem to indicate that high dose baclofen is effective. Given the risk of side effects, overdose, and functional impairment, along with compelling contrary findings, the course of action is not very clear.
Implications for clinical practice
Baclofen should not be readily prescribed since it is an experiment with one participant. It requires intensive consultation with the patient so that they can provide informed consent. De Beaurepaire et al. (2019) described that “Patients should be informed that the use of baclofen for AUD is as an ‘off-label’ prescription, that no optimal fixed-dose has been established, and that existing clinical evidence on efficacy is inconsistent”. The continued use of baclofen must be constantly evaluated in relation to the risks, low success rate, and possible adverse outcomes. Baclofen therapy must begin with a clear exit plan for safe cessation. Referral to psychotherapy or other non-pharmacological treatment is an important adjunct therapy. Healthcare professionals must also take into account non-prescribed, self-administered uses of baclofen. The symptoms of overdose and withdrawal, as well as the ability to provide a referral to a specialty facility for detoxification, can be important tools in managing ongoing baclofen therapy.
The rising popularity of baclofen in the treatment of AUD should be monitored with caution. The use of the drug for this purpose has not yet reached a high quality of evidence. The best practices remain to be identified. Withdrawal from baclofen or overdose can result in death, and this requires attention in cases where there are possible symptoms in a patient who is or may be taking baclofen. In terms of treatment for AUD, further research and guidance are needed in relation to the safety, dosage and structure of the therapeutic treatment. Its use may not be warranted given the risks it carries and the lack of evidence regarding effectiveness. What have been your experiences in relation to baclofen, and this patient population?
Dive in to the research
Opens in a new tab.
Agabio, R., Baldwin, D. S., Amaro, H., Leggio, L., & Sinclair, J. M. (2021). The influence of anxiety symptoms on clinical outcomes during baclofen treatment of alcohol use disorder: A systematic review and meta-analysis. Neuroscience & Biobehavioral Reviews. DOI: 10.1113/JP280378 https://physoc.onlinelibrary.wiley.com/doi/full/10.1113/JP280378
De Beaurepaire, R., Sinclair, J., Heydtmann, M., Addolorato, G., Aubin, H. J., Beraha, E. M., … & Agabio, R. (2019). The use of baclofen as a treatment for alcohol use disorder: a clinical practice perspective. Frontiers in psychiatry, 9, 708. DOI: 10.3389/fpsyt.2018.00708 https://www.frontiersin.org/articles/10.3389/fpsyt.2018.00708/full
Floyd, C. N., Wood, D. M., & Dargan, P. I. (2018). Baclofen in gamma-hydroxybutyrate withdrawal: patterns of use and online availability. European journal of clinical pharmacology, 74(3), 349-356. doi url
Gao, J., Cao, J., Guo, T., & Xiao, Y. (2018). Association between alcoholic interventions and abstinence rates for alcohol use disorders: A meta-analysis. Medicine, 97(50). DOI: 10.1097/MD.0000000000013566 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6320082/
Johnstone, A., Grigoras, I., Petitet, P., Capitão, L. P., & Stagg, C. J. (2021). A single, clinically relevant dose of the GABAB agonist baclofen impairs visuomotor learning. The Journal of Physiology, 599(1), 307-322. DOI: 10.1113/JP280378 https://physoc.onlinelibrary.wiley.com/doi/epdf/10.1113/JP280378
Kent, C. N., Park, C., & Lindsley, C. W. (2020). Classics in chemical neuroscience: Baclofen. ACS chemical neuroscience, 11(12), 1740-1755. DOI: 10.1021/acschemneuro.0c00254 https://pubs.acs.org/doi/pdf/10.1021/acschemneuro.0c00254
Minozzi, S., Saulle, R., & Rösner, S. (2018). Baclofen for alcohol use disorder. Cochrane Database of Systematic Reviews, (11).
Müller, C. A., Geisel, O., Pelz, P., Higl, V., Krüger, J., Stickel, A., … & Heinz, A. (2015). High-dose baclofen for the treatment of alcohol dependence (BACLAD study): a randomized, placebo-controlled trial. European neuropsychopharmacology, 25(8), 1167-1177.
Pucks-Faes, E., Matzak, H., Hitzenberger, G., Genelin, E., Halbmayer, L. M., Fava, E., … & Saltuari, L. (2019). Intrathecal Baclofen Trial Before Device Implantation: 12-Year Experience With Continuous Administration. Archives of physical medicine and rehabilitation, 100(5), 837-843. DOI: 10.1016/j.apmr.2018.09.124 https://linkinghub.elsevier.com/retrieve/pii/S0003-9993(18)31398-4
Sjoerds, Z., Stufflebeam, S. M., Veltman, D. J., Van den Brink, W., Penninx, B. W., & Douw, L. (2017). Loss of brain graph network efficiency in alcohol dependence. Addiction biology, 22(2), 523-534. DOI: 10.1111/adb.12346 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4917471/