Slides and Transcript
Slide 1 of 28
Now, let’s talk about expanding treatment options for alcohol use disorder. These are medications that are not FDA approved for treatment of AUD and the three most common are gabapentin, topiramate and baclofen.
Slide 2 of 28
Gabapentin and topiramate. Let’s talk about them together. They’re both antiepileptic drugs. Gabapentin is principally indicated for treatment of neuropathy, topiramate for treatment of seizures, migraines.
References:
- Reus, V. I., Fochtmann, L. J., Bukstein, O., Eyler, A. E., Hilty, D. M., Horvitz-Lennon, M., Mahoney, J., Pasic, J., Weaver, M., Wills, C. D., McIntyre, J., Kidd, J., Yager, J., & Hong, S. H. (2018). The American Psychiatric Association Practice Guideline for the Pharmacological Treatment of Patients With Alcohol Use Disorder. The American Journal of Psychiatry, 175(1), 86–90. https://doi.org/10.1176/appi.ajp.2017.1750101
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Slide 3 of 28
So let’s start with statement number 11 from APA Guidelines. They suggest that topiramate or gabapentin can be offered to patients with moderate to severe alcohol use disorder who, one, have a goal of reducing alcohol consumption or achieving abstinence; two, prefer topiramate or gabapentin or are intolerant to or haven’t responded to naltrexone and acamprosate, and don’t have any contraindications to the use of these medications such as, for example, allergies to them. So even though this is off-label, there’s actually fairly strong support in the field for the use of these and you would not be in trouble using these in those with alcohol use disorder.
References:
- Reus, V. I., Fochtmann, L. J., Bukstein, O., Eyler, A. E., Hilty, D. M., Horvitz-Lennon, M., Mahoney, J., Pasic, J., Weaver, M., Wills, C. D., McIntyre, J., Kidd, J., Yager, J., & Hong, S. H. (2018). The American Psychiatric Association Practice Guideline for the Pharmacological Treatment of Patients With Alcohol Use Disorder. The American Journal of Psychiatry, 175(1), 86–90. https://doi.org/10.1176/appi.ajp.2017.1750101
Slide 4 of 28
Importantly, especially gabapentin here in the United States is very widely used because people tend to come from detox on gabapentin for two reasons. It’s antiepileptic, so it should be protective against alcoholic withdrawal seizures. And two, it’s calming, so that the anxiety that accompanies alcohol withdrawal is treated. So those two reasons are reasons why patients already come to you on gabapentin after undergoing detox.
References:
- Reus, V. I., Fochtmann, L. J., Bukstein, O., Eyler, A. E., Hilty, D. M., Horvitz-Lennon, M., Mahoney, J., Pasic, J., Weaver, M., Wills, C. D., McIntyre, J., Kidd, J., Yager, J., & Hong, S. H. (2018). The American Psychiatric Association Practice Guideline for the Pharmacological Treatment of Patients With Alcohol Use Disorder. The American Journal of Psychiatry, 175(1), 86–90. https://doi.org/10.1176/appi.ajp.2017.1750101
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Slide 5 of 28
Why would gabapentin and topiramate work? Well, in an earlier discussion I had talked about glutamate being a bad guy in terms of supporting things like craving but also that GABA is a good guy. So gabapentin enhances GABA-ergic tone and therefore it should reduce craving, reduce irritability, reduce impulsivity and reduce substance use. Topiramate suppresses glutamate tone and so it does the same thing – reduces craving, reduces irritability, reduces impulsivity, reduces substance use. So both of those are preclinical reasons why they would be effective in the treatment of many substances not just alcohol.
References:
- Blodgett, J. C., Del Re, A. C., Maisel, N. C., & Finney, J. W. (2014). A meta-analysis of topiramate's effects for individuals with alcohol use disorders. Alcoholism, Clinical and Experimental Research, 38(6), 1481–1488. https://doi.org/10.1111/acer.12411
- Kranzler, H. R., Feinn, R., Morris, P., & Hartwell, E. E. (2019). A meta-analysis of the efficacy of gabapentin for treating alcohol use disorder. Addiction, 114(9), 1547–1555. https://doi.org/10.1111/add.14655
Slide 6 of 28
I’ll just say to summarize, gabapentin enhances GABA-ergic tone and so suppresses dopamine release in the nucleus accumbens. Topiramate suppresses glutamatergic tone and through the enhanced release of taurine enhances GABA-ergic tone.
References:
- Blodgett, J. C., Del Re, A. C., Maisel, N. C., & Finney, J. W. (2014). A meta-analysis of topiramate's effects for individuals with alcohol use disorders. Alcoholism, Clinical and Experimental Research, 38(6), 1481–1488. https://doi.org/10.1111/acer.12411
- Kranzler, H. R., Feinn, R., Morris, P., & Hartwell, E. E. (2019). A meta-analysis of the efficacy of gabapentin for treating alcohol use disorder. Addiction, 114(9), 1547–1555. https://doi.org/10.1111/add.14655
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Slide 7 of 28
Topiramate. Let’s talk about that first because in fact the evidence is a little stronger that it is effective in treatment of alcohol use disorder than for gabapentin. You need to start low and go slow. Otherwise, the nickname dopamax comes into play where people feel slowed, cognitively dulled, I really don’t like it. And that’s why many topiramate studies show high dropout rates because there was too rapid of dialing up.
References:
- Reus, V. I., Fochtmann, L. J., Bukstein, O., Eyler, A. E., Hilty, D. M., Horvitz-Lennon, M., Mahoney, J., Pasic, J., Weaver, M., Wills, C. D., McIntyre, J., Kidd, J., Yager, J., & Hong, S. H. (2018). The American Psychiatric Association Practice Guideline for the Pharmacological Treatment of Patients With Alcohol Use Disorder. The American Journal of Psychiatry, 175(1), 86–90. https://doi.org/10.1176/appi.ajp.2017.1750101
- Blodgett, J. C., Del Re, A. C., Maisel, N. C., & Finney, J. W. (2014). A meta-analysis of topiramate's effects for individuals with alcohol use disorders. Alcoholism, Clinical and Experimental Research, 38(6), 1481–1488. https://doi.org/10.1111/acer.12411
Slide 8 of 28
In week 1, it would be 25 mg in the morning and at night. Week 2, 50 mg morning and night. Week 3, 75 mg morning and night. Week 4, 100 mg orally morning and night.
References:
- Reus, V. I., Fochtmann, L. J., Bukstein, O., Eyler, A. E., Hilty, D. M., Horvitz-Lennon, M., Mahoney, J., Pasic, J., Weaver, M., Wills, C. D., McIntyre, J., Kidd, J., Yager, J., & Hong, S. H. (2018). The American Psychiatric Association Practice Guideline for the Pharmacological Treatment of Patients With Alcohol Use Disorder. The American Journal of Psychiatry, 175(1), 86–90. https://doi.org/10.1176/appi.ajp.2017.1750101
- Blodgett, J. C., Del Re, A. C., Maisel, N. C., & Finney, J. W. (2014). A meta-analysis of topiramate's effects for individuals with alcohol use disorders. Alcoholism, Clinical and Experimental Research, 38(6), 1481–1488. https://doi.org/10.1111/acer.12411
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Slide 9 of 28
Then you can go a little quicker. Week 5, 150, 150. And week 6, 200, 200.
References:
- Reus, V. I., Fochtmann, L. J., Bukstein, O., Eyler, A. E., Hilty, D. M., Horvitz-Lennon, M., Mahoney, J., Pasic, J., Weaver, M., Wills, C. D., McIntyre, J., Kidd, J., Yager, J., & Hong, S. H. (2018). The American Psychiatric Association Practice Guideline for the Pharmacological Treatment of Patients With Alcohol Use Disorder. The American Journal of Psychiatry, 175(1), 86–90. https://doi.org/10.1176/appi.ajp.2017.1750101
- Blodgett, J. C., Del Re, A. C., Maisel, N. C., & Finney, J. W. (2014). A meta-analysis of topiramate's effects for individuals with alcohol use disorders. Alcoholism, Clinical and Experimental Research, 38(6), 1481–1488. https://doi.org/10.1111/acer.12411
Slide 10 of 28
Now, if you’re already getting efficacy in terms of the person having achieved their goal of reduced use or abstinence, you don’t need to keep increasing it. So there are patients I have that are on 50 mg twice a day or 75 mg twice a day, and I don’t go higher.
References:
- Reus, V. I., Fochtmann, L. J., Bukstein, O., Eyler, A. E., Hilty, D. M., Horvitz-Lennon, M., Mahoney, J., Pasic, J., Weaver, M., Wills, C. D., McIntyre, J., Kidd, J., Yager, J., & Hong, S. H. (2018). The American Psychiatric Association Practice Guideline for the Pharmacological Treatment of Patients With Alcohol Use Disorder. The American Journal of Psychiatry, 175(1), 86–90. https://doi.org/10.1176/appi.ajp.2017.1750101
- Blodgett, J. C., Del Re, A. C., Maisel, N. C., & Finney, J. W. (2014). A meta-analysis of topiramate's effects for individuals with alcohol use disorders. Alcoholism, Clinical and Experimental Research, 38(6), 1481–1488. https://doi.org/10.1111/acer.12411
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Slide 11 of 28
The side effects for topiramate include dizziness and drowsiness; problems with speech, memory and vision – those really do result in people stopping it; numbness, tingling and burning in the arms and legs which is a little surprising given that it should be like gabapentin but it’s not; that metallic taste, feeling nervous, stomach pains, diarrhea, fever and weight loss. Some people actually like it because it, especially there’s an urban legend that you will lose a lot of weight, but often people do lose some weight.
References:
- Reus, V. I., Fochtmann, L. J., Bukstein, O., Eyler, A. E., Hilty, D. M., Horvitz-Lennon, M., Mahoney, J., Pasic, J., Weaver, M., Wills, C. D., McIntyre, J., Kidd, J., Yager, J., & Hong, S. H. (2018). The American Psychiatric Association Practice Guideline for the Pharmacological Treatment of Patients With Alcohol Use Disorder. The American Journal of Psychiatry, 175(1), 86–90. https://doi.org/10.1176/appi.ajp.2017.1750101
- Blodgett, J. C., Del Re, A. C., Maisel, N. C., & Finney, J. W. (2014). A meta-analysis of topiramate's effects for individuals with alcohol use disorders. Alcoholism, Clinical and Experimental Research, 38(6), 1481–1488. https://doi.org/10.1111/acer.12411
Slide 12 of 28
Cold symptoms. You can get some severe eye problems, suicidal thoughts and behavior, and importantly, metabolic acidosis. So if you have metabolic acidosis, it’s not good in terms of what’s happening with your kidneys. In clinical trials, dropouts as high as 60% have been reported. So it’s not easily tolerated.
References:
- Reus, V. I., Fochtmann, L. J., Bukstein, O., Eyler, A. E., Hilty, D. M., Horvitz-Lennon, M., Mahoney, J., Pasic, J., Weaver, M., Wills, C. D., McIntyre, J., Kidd, J., Yager, J., & Hong, S. H. (2018). The American Psychiatric Association Practice Guideline for the Pharmacological Treatment of Patients With Alcohol Use Disorder. The American Journal of Psychiatry, 175(1), 86–90. https://doi.org/10.1176/appi.ajp.2017.1750101
- Blodgett, J. C., Del Re, A. C., Maisel, N. C., & Finney, J. W. (2014). A meta-analysis of topiramate's effects for individuals with alcohol use disorders. Alcoholism, Clinical and Experimental Research, 38(6), 1481–1488. https://doi.org/10.1111/acer.12411
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Slide 13 of 28
Let’s look at that meta-analysis now, from Blodgett et al. in 2014. You can see here very good what’s called Hedges’ or G score, which is similar to an odds ratio, of just under 0.5 for achieving abstinence, and as well for heavy drinking. So when tolerated, it can be a very effective medication for treatment of alcohol use disorder.
References:
- Blodgett, J. C., Del Re, A. C., Maisel, N. C., & Finney, J. W. (2014). A meta-analysis of topiramate's effects for individuals with alcohol use disorders. Alcoholism, Clinical and Experimental Research, 38(6), 1481–1488. https://doi.org/10.1111/acer.12411
Slide 14 of 28
Gabapentin. It again could be used off-label for alcohol use disorder. So even though some people start right at 300 mg, t.i.d. and that’s well tolerated, if it’s not well tolerated, somebody becomes too sedated and they don’t want to use it. I use a more conservative approach of starting at 100 mg three times a day especially in those prone to sedation. And then if well tolerated, I’ll either go to 200 mg three times a day or if they have no sedation at all I’ll go then right to the 300 mg three times a day after a week or so.
References:
- Reus, V. I., Fochtmann, L. J., Bukstein, O., Eyler, A. E., Hilty, D. M., Horvitz-Lennon, M., Mahoney, J., Pasic, J., Weaver, M., Wills, C. D., McIntyre, J., Kidd, J., Yager, J., & Hong, S. H. (2018). The American Psychiatric Association Practice Guideline for the Pharmacological Treatment of Patients With Alcohol Use Disorder. The American Journal of Psychiatry, 175(1), 86–90. https://doi.org/10.1176/appi.ajp.2017.1750101
- Kranzler, H. R., Feinn, R., Morris, P., & Hartwell, E. E. (2019). A meta-analysis of the efficacy of gabapentin for treating alcohol use disorder. Addiction, 114(9), 1547–1555. https://doi.org/10.1111/add.14655
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Slide 15 of 28
In medically managed alcohol withdrawal, patients are started right away at 300 mg three times a day, and they’re rapidly titrated to symptom control, and then they transition already on the medication. So, patients come to me on 300 mg three times a day or 600 mg three times a day. Why so high? ‘Cause in fact, we tend to clear most of it through our GI tract. So if you had flushed that goldfish down the toilet, he won’t be having a seizure anytime soon. It’s poorly absorbed.
References:
- Reus, V. I., Fochtmann, L. J., Bukstein, O., Eyler, A. E., Hilty, D. M., Horvitz-Lennon, M., Mahoney, J., Pasic, J., Weaver, M., Wills, C. D., McIntyre, J., Kidd, J., Yager, J., & Hong, S. H. (2018). The American Psychiatric Association Practice Guideline for the Pharmacological Treatment of Patients With Alcohol Use Disorder. The American Journal of Psychiatry, 175(1), 86–90. https://doi.org/10.1176/appi.ajp.2017.1750101
- Kranzler, H. R., Feinn, R., Morris, P., & Hartwell, E. E. (2019). A meta-analysis of the efficacy of gabapentin for treating alcohol use disorder. Addiction, 114(9), 1547–1555. https://doi.org/10.1111/add.14655
Slide 16 of 28
So in those of us that treat alcohol use disorder, we may go as high as 900 mg t.i.d. But in chronic pain clinics, I’ve seen dosing as high as 5400 mg a day. In correctional institutions, because it’s so calming, this actually is a medication that has become abused by some. And also, people tend to feel that it prolongs the effect of opioids and so it’s also abused by those with opioid use disorder. So be careful and watch for any flags of overuse.
References:
- Reus, V. I., Fochtmann, L. J., Bukstein, O., Eyler, A. E., Hilty, D. M., Horvitz-Lennon, M., Mahoney, J., Pasic, J., Weaver, M., Wills, C. D., McIntyre, J., Kidd, J., Yager, J., & Hong, S. H. (2018). The American Psychiatric Association Practice Guideline for the Pharmacological Treatment of Patients With Alcohol Use Disorder. The American Journal of Psychiatry, 175(1), 86–90. https://doi.org/10.1176/appi.ajp.2017.1750101
- Kranzler, H. R., Feinn, R., Morris, P., & Hartwell, E. E. (2019). A meta-analysis of the efficacy of gabapentin for treating alcohol use disorder. Addiction, 114(9), 1547–1555. https://doi.org/10.1111/add.14655
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Slide 17 of 28
Common side effects. The most common one is sedation, but there are also dizziness, some edema, weight gain, and eye problems. In carcel settings, it may be misused. And when combined with opioids or benzodiazepines, it can exacerbate respiratory suppression. So if somebody comes to you and they’re already on a benzodiazepine and opioid which automatically raises my hackles, I would tend not to add gabapentin to that.
References:
- Reus, V. I., Fochtmann, L. J., Bukstein, O., Eyler, A. E., Hilty, D. M., Horvitz-Lennon, M., Mahoney, J., Pasic, J., Weaver, M., Wills, C. D., McIntyre, J., Kidd, J., Yager, J., & Hong, S. H. (2018). The American Psychiatric Association Practice Guideline for the Pharmacological Treatment of Patients With Alcohol Use Disorder. The American Journal of Psychiatry, 175(1), 86–90. https://doi.org/10.1176/appi.ajp.2017.1750101
- Kranzler, H. R., Feinn, R., Morris, P., & Hartwell, E. E. (2019). A meta-analysis of the efficacy of gabapentin for treating alcohol use disorder. Addiction, 114(9), 1547–1555. https://doi.org/10.1111/add.14655
Slide 18 of 28
If we look at the meta-analysis from Kranzler and colleagues in 2019, you can see that present heavy drinking days has a somewhat bigger effect size, something like about 0.3 versus what turns out to be a non-significant effect on abstinence. So that’s why I talked about topiramate first, because in most endpoints topiramate shows efficacy for treatment of alcohol use disorder while gabapentin is somewhat similar to naltrexone in having an effect on heavy drinking days but not abstinence.
References:
- Kranzler, H. R., Feinn, R., Morris, P., & Hartwell, E. E. (2019). A meta-analysis of the efficacy of gabapentin for treating alcohol use disorder. Addiction, 114(9), 1547–1555. https://doi.org/10.1111/add.14655
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Slide 19 of 28
I also show in effect here by Anton and colleagues in 2020 where you can see interestingly that those with high alcohol withdrawal scores versus low alcohol withdrawal scores showed a much larger effect for gabapentin. So those that have high alcohol withdrawal scores and were treated for that when they came to you might be better candidates for the treatment use of gabapentin than those that didn’t have much alcohol withdrawal.
References:
- Anton, R. F., Latham, P., Voronin, K., Book, S., Hoffman, M., Prisciandaro, J., & Bristol, E. (2020). Efficacy of Gabapentin for the Treatment of Alcohol Use Disorder in Patients With Alcohol Withdrawal Symptoms: A Randomized Clinical Trial. JAMA Internal Medicine, 180(5), 728–736. https://doi.org/10.1001/jamainternmed.2020.0249
Slide 20 of 28
Finally, baclofen. So baclofen is a GABA-B agonist. It’s usually used for the treatment of spasm. It can be abused but not often. And in very high doses, there are even implantable baclofen pumps that can be effective for those with marked spasticity such as with multiple sclerosis, traumatic brain injury, etc. It should reduce the firing rate in reward pathways and reduce the reinforcing effects of alcohol. Meta-analyses are quite varied in supporting whether baclofen achieves effective endpoints in alcohol use disorder.
References:
- Reus, V. I., Fochtmann, L. J., Bukstein, O., Eyler, A. E., Hilty, D. M., Horvitz-Lennon, M., Mahoney, J., Pasic, J., Weaver, M., Wills, C. D., McIntyre, J., Kidd, J., Yager, J., & Hong, S. H. (2018). The American Psychiatric Association Practice Guideline for the Pharmacological Treatment of Patients With Alcohol Use Disorder. The American Journal of Psychiatry, 175(1), 86–90. https://doi.org/10.1176/appi.ajp.2017.1750101
- Agabio, R., Saulle, R., Rösner, S., & Minozzi, S. (2023). Baclofen for alcohol use disorder. The Cochrane Database of Systematic Reviews, 1(1), CD012557. https://doi.org/10.1002/14651858.CD012557.pub3
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Slide 21 of 28
In a 2023 Cochrane review, which I find these Cochrane reviews are often very extensive but conservative in their conclusions, in an analysis of 17 studies with under 2000 participants with alcohol use disorder, doses of baclofen were 30 mg a day on average, and compared with placebo, baclofen probably helped people with alcohol use disorder in reducing the risk of relapse and increasing the risk of abstinence days.
References:
- Agabio, R., Saulle, R., Rösner, S., & Minozzi, S. (2023). Baclofen for alcohol use disorder. The Cochrane Database of Systematic Reviews, 1(1), CD012557. https://doi.org/10.1002/14651858.CD012557.pub3
Slide 22 of 28
It was more effective in those among detoxified than non-detoxified patients, so again patients that come to you having achieved some degree of abstinence. There’s probably no difference in the rate of heavy drinking days or cravings. Baclofen did not increase the rate of dropout despite a fairly high side effect burden especially because of sedation.
References:
- Agabio, R., Saulle, R., Rösner, S., & Minozzi, S. (2023). Baclofen for alcohol use disorder. The Cochrane Database of Systematic Reviews, 1(1), CD012557. https://doi.org/10.1002/14651858.CD012557.pub3
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Slide 23 of 28
Now, baclofen dosing starts at about 5 mg three times a day, and usually every one to two weeks you can titrate that by 5 mg a dose. So you might go 15 mg a day, then after one to two weeks, 30 mg a day. But you can titrate as fast as every three days. Believe it or not, in clinical trials, doses up to 400 mg a day have been used. I personally have never done that, but clinical trials especially in Europe have supported the use of high doses for the treatment of alcohol use disorder.
References:
- de Beaurepaire, R., & Jaury, P. (2024). Baclofen in the treatment of alcohol use disorder: Tailored doses matter. Alcohol and Alcoholism, 59(2), agad090. https://doi.org/10.1093/alcalc/agad090
Slide 24 of 28
Side effects are sedation, dizziness, weakness, fatigue. Headache, I don’t see that very often. Trouble sleeping, nausea, increased urination. Again, when combined with opioids or benzodiazepines, just like with gabapentin, it can exacerbate respiratory suppression, so use care.
References:
- Reus, V. I., Fochtmann, L. J., Bukstein, O., Eyler, A. E., Hilty, D. M., Horvitz-Lennon, M., Mahoney, J., Pasic, J., Weaver, M., Wills, C. D., McIntyre, J., Kidd, J., Yager, J., & Hong, S. H. (2018). The American Psychiatric Association Practice Guideline for the Pharmacological Treatment of Patients With Alcohol Use Disorder. The American Journal of Psychiatry, 175(1), 86–90. https://doi.org/10.1176/appi.ajp.2017.1750101
- de Beaurepaire, R., & Jaury, P. (2024). Baclofen in the treatment of alcohol use disorder: Tailored doses matter. Alcohol and Alcoholism, 59(2), agad090. https://doi.org/10.1093/alcalc/agad090
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Slide 25 of 28
There is something called tailored dosing of baclofen which is the use of these high doses. You increase the dose of baclofen gradually until a patient feels an absence of craving for alcohol. That’s the tailored method and the dose can be quite variable. Again, using high dose is more effective than low doses. Observational studies have consistently shown marked effectiveness of baclofen with this approach. Analysis of the circumstances in which severe adverse effects occur suggest that careful monitoring of baclofen prescribing might prevent a large majority of severe adverse effects, so in other words, more frequent visits, more careful titration to avoid severe adverse effects.
References:
- de Beaurepaire, R., & Jaury, P. (2024). Baclofen in the treatment of alcohol use disorder: Tailored doses matter. Alcohol and Alcoholism, 59(2), agad090. https://doi.org/10.1093/alcalc/agad090
Slide 26 of 28
The combined sedative effects of alcohol and baclofen may explain the majority of severe adverse effects, and so in these studies and I’ve included one by de Beaurepaire et al. in 2024, that in fact they feel like if you carefully monitor what’s happening with alcohol, and you provide higher levels of care to prevent use of alcohol during the baclofen titration that you may be able to then get them to an effective dose without severe adverse effects or dropout.
References:
- de Beaurepaire, R., & Jaury, P. (2024). Baclofen in the treatment of alcohol use disorder: Tailored doses matter. Alcohol and Alcoholism, 59(2), agad090. https://doi.org/10.1093/alcalc/agad090
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Slide 27 of 28
So key points for the use of off-label three non-FDA-approved MAUDs. These are topiramate, gabapentin and baclofen. Gabapentin acts to enhance GABA-ergic tone. Topiramate suppresses glutamatergic tone and enhances GABA-ergic tone. Topiramate, while less well tolerated than gabapentin, promotes abstinence and reduces heavy drinking days in those with alcohol use disorder.
Slide 28 of 28
Gabapentin is more widely used since it’s better tolerated, and is often started during treatment of alcohol withdrawal. In those patients, it appears more effective to reduce heavy drinking in those with alcohol withdrawal as opposed to those with mild or no alcohol withdrawal. And finally, baclofen as a GABA-B agonist should reduce the reinforcing effects of alcohol but meta-analyses have been varied in supporting its efficacy as an MAUD.
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