Baclofen for back pain

Section 5: Practical examples of dose adjustments for side effects.

Here are a couple of examples of how to adjust dosing regimes to help with side effects.

Example 1:

A patient starts on baclofen at 5mg at bedtime but even with that dose, has severe nausea and is reluctant to take any doses in the day because she needs to go to work.

Slide:

Reduce the dose to 2.5mg (1/4 of a 10mg tablet) at bedtime taken with an antinausea tablet (prochlorperazine 5mg) and work slowly up to taking this up to 2.5mg 3 times a day, doing the increases on non-working days. Once at 2.5mg three times daily, wean off the antinausea tablets. Once stable, repeat this process going slowly from 2.5mg three times daily to 5mg three times daily. The patient can then continue to work the dose upwards as fast as they can tolerate but it is generally much easier after the first few dose increases.

Example 2:

A patient feels fine on baclofen 10mg three times a day. The dose is raised to 15mg three times a day over a standard three day period (10/10/10 to 10/10/15 to 10/15/15 to 15/15/15) but he gets a severe headache after taking each 15mg dose.

Here are some options:

Slide:

Option 1:

Option 2:

The number of days between each dose increase can vary. If a headache appears, the dose rise has been too fast. Go back to the comfortable dose, wait there a few days and try going up again.

Option 3:

Fractionate the total daily dose of 45mg (15mg x 3) over the day: 10 breakfast/5 mid morning/10 lunchtime/5 mid afternoon/10 dinner time/5 bedtime

Here the daily dose is the same but the smaller, more frequent doses mean that the baclofen concentration in the brain doesn’t rise as high after each dose. After 3-7 days of this 6x/day regime, start the switch back to 15mg three times daily.

The Truth About Taking High Doses of Baclofen to Suppress Alcohol Cravings

“The very day I began taking baclofen in high doses, my brain stopped screaming for alcohol. I drank heavily on a daily basis for the past 30 years. The longest I was ever able to abstain based on will-power was two weeks,” said Randy.

He had tried Alcoholics Anonymous, SMART Recovery, Rational Recovery, therapy, and everything he could think of…but nothing worked. Then he read a book called The End of My Addiction by Dr. Olivier Ameisen, a French cardiologist working in New York. The book was about baclofen – a medication that Ameisen said suppressed alcohol cravings.

Ameisen experimented on himself and found baclofen to be effective in curing his own alcohol problem. In 2004, he published a paper entitled “Complete and Prolonged Suppression of Symptoms and Consequences of Alcohol-Dependence Using High-Dose Baclofen: A Self-Case Report of a Physician” in the journal Alcohol and Alcoholism. The paper generated interest in the scientific community surrounding a possible wonder drug for alcohol use disorder, and other scientists began to research baclofen’s potential.

Baclofen 101

Baclofen is a muscle relaxant sold under the brand name Lioresal. It is used to treat muscle spasms such as those caused by multiple sclerosis or injuries. It works by activating GABA receptors in the brain, causing a relaxing effect.

In addition to relaxing the muscles, baclofen seems to have an anxiolytic effect, meaning that it reduces anxiety. This makes sense because the GABA receptors control anxiety. Other drugs such as benzodiazepines (Xanax, Klonipin, or Valium for example) also work on the GABA receptors, causing an anti-anxiety effect.

One of the most common chemicals that activates GABA receptors is – you guessed it – alcohol! So we can suppose (though we cannot be sure) that the mechanism by which baclofen works to suppress alcohol cravings is the activation of GABA receptors, which reduces the need for alcohol. While this effect does not always appear at the doses commonly used for muscle relaxation, some people with alcohol dependence respond to higher doses.

A series of studies followed Dr. Ameisen’s initial report, but showed mixed results. A 2015 randomized controlled trial (a study where some patients are assigned to a treatment while others are given a placebo, a pill that looks like the treatment drug but contains no active ingredients), called the BACLAD study, found that, at doses up to 270 mg per day, patients treated with baclofen achieved more days of total abstinence from alcohol than those who did not get the drug. This study also found no serious adverse events, meaning that no one had a serious negative reaction to the drug.

A 2016 study, however, found different results. Scientists measured the time to first relapse for patients on different doses of baclofen (150 mg, 30 mg, or none) and found no significant differences between the groups. Patients also reported side effects such as sleepiness and dry mouth. It is important to note that the high dose used in this study was 150 mg, significantly less than the 270 used in the BACLAD study where patients treated with baclofen achieved more days of abstinence than untreated patients. It is also important to note that these two studies did not measure the same thing: the BACLAD study measured total days of abstinence, while the second study measured time to first relapse (as defined by first heavy drinking day while on the drug). Patients were dismissed from the study after their first relapse, so we have no way of knowing how many days of total abstinence they might have achieved had they been allowed to continue.

The Risks of Baclofen

Like any drug, baclofen is not without risks. The most commonly reported side effects are drowsiness and dry mouth. These seem to appear at higher doses, while those who take lower doses experience fewer side effects.

Baclofen is definitely not a “do it yourself” drug. You should not try baclofen for suppression of alcohol cravings without close supervision from your doctor. Even if you have been prescribed baclofen for muscle spasms or pain, do not try it at higher doses than you have been prescribed without talking to your doctor in detail.

Baclofen doses must be titrated up, meaning that you start at a low dose and gradually increase it as instructed by your doctor. Also, as with benzodiazepines, stopping baclofen abruptly can cause serious problems, such as panic attacks and even seizures.

Baclofen in Action

Anna, a 53-year-old corporate executive who raised two children while climbing to the top of her career while struggling with alcohol dependence, reported on her experience with baclofen, “I take 20 mg three times a day. When I was suffering with detox, the dose was doubled. I would not have been able to abstain without it.” She also said that it reduced her chronic anxiety and helps her sleep.

Zephyr, whose parents own a restaurant, found herself drinking way too much of the wine that was part of her culture; by the age of 40, she developed a serious drinking problem. She tried everything from AA to intensive therapy to naltrexone, but only found relief from a very low dose of baclofen. “I’ve been using 30 mg a day for about three months. It’s amazing! Even though I did drink for the 1.5 months while on it, I never overdid it. It significantly reduced my intake and cravings. Now I am abstinent again and no cravings! It’s the only single drug that ever helped me.”

Zephyr also noted one unexpected effect: “It does this weird thing: alcohol starts tasting funny. My favorite white wine started tasting weird after I’d been on it for a while. I didn’t like it anymore.”

Using Medications as a Treatment Tool

Efrem Nulman, a PhD psychotherapist with expertise in addiction and psychopharmacology, said, “For the last ten to twelve years, I’ve been advising doctors to prescribe baclofen for a number of different problems or dependencies. It’s a very calming drug, and it decreases cravings. I’ve treated polydrug users and even heroin users who were prescribed baclofen, as well as people with anxiety, extreme fear, and post-traumatic stress disorder. Bad reactions can occur if people don’t titrate it up slowly, and it doesn’t work for everyone, but we’ve had success with it.”

There is no single solution to the problem of addictive cravings, and many people find that using medication in conjunction with therapy and social support helps them confront the issues underlying their addictive behaviors, increasing the chances of sustained recovery. However, given the success of baclofen in clinical trials and individual reports to help to suppress alcohol cravings, those suffering from alcohol problems and the professionals who treat them should be educated about its potential benefits and risks. Those of us who struggle with substances deserve real information about and access to all the options available.

Ameisen O. Complete and prolonged suppression of symptoms and consequences of alcohol-dependence using high-dose baclofen: a self-case report of a physician.
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Eur Neuropsychopharmacol. 2016 Dec;26(12):1950-1959.

Images Courtesy of iStock

What is Baclofen Used For & Is Baclofen Addictive?

What is baclofen used for? Baclofen, also known by the brand names Kemstro and Lioresal, is a prescription drug used to relieve muscle spasms, primarily in the treatment of multiple sclerosis or spinal cord diseases.

According to the U.S. National Library of Medicine, this medication relieves spasms of the musculoskeletal system, relieves pain, and improves muscle movement.

In the past decade, baclofen has been used with increasing frequency in the treatment of drug and alcohol addiction. In this usage, baclofen functions to lessen the symptoms of withdrawal. Prescribing baclofen to treat addiction is still considered an “off-label” use of the medication, or a use outside of what is approved by the FDA, but this use has shown some success in clinical trials, according to a study published by Cochrane Database of Systematic Review.

The Issue of Baclofen Addiction

Addiction is a problem that affects people from all demographics. The National Institute on Drug Abuse (NIDA) reports a 2.5-fold increase in total overdose deaths from the years 2001-2013, and overdose deaths relating to opioid pain relievers saw an even larger increase.

The Substance Abuse and Mental Health Services Administration (SAMHSA) reported in 2009 that 23.5 million people needed treatment for alcohol or drug addiction. In the face of this ever-growing prevalence of addiction, the medical field has increasingly begun to explore the possibilities of addiction recovery that is assisted by medication. According to SAMHSA, various medications are currently used for this purpose, including buprenorphine, methadone, and naltrexone. In addition to these medications, other medications like baclofen are often use in an off-label manner to assist in addiction treatment.

Baclofen was originally designed as a drug for the treatment of epilepsy. GABAb Receptor Pharmacology reports that after first being synthesized in 1962, the drug was only minimally successful in the treatment of seizures, but it was widely used to decrease spasticity caused by a variety of diseases. In 2009, a cardiologist named Olivier Ameisen published a memoir detailing his own recovery from alcoholism using baclofen, and this led to subsequent investigations into the efficacy of the drug as a treatment for addiction. While use of baclofen in addiction treatment is still considered experimental, it is gaining prominence in the field, and clinical trials continue to explore the possibilities of its use.

Baclofen Dosage and Side Effects

According to the U.S. National Library of Medicine, side effects of baclofen may include the following:

  • Drowsiness
  • Dizziness
  • Muscle weakness
  • Confusion
  • Upset stomach

More severe side effects of this drug include difficulty breathing and seizures; medical help should be sought immediately if either of these side effects is experienced. Side effects are generally minimal and occur primarily when first starting treatment with this medication.

Some individuals may be more susceptible to side effects, including the elderly, and those with impaired renal function. Individuals with galactose intolerance, active peptic ulceration, and porphyria should not take this medication. Additionally, baclofen should be prescribed with caution to the following individuals:

  • Those with severe psychiatric disorders
  • Individuals with seizure disorders
  • Those already receiving antihypertensive therapy
  • Anyone suffering from sphincter hypertonia
  • Individuals with liver disease or diabetes mellitus

According to the Electronic Medicines Compendium, dosage of baclofen is increased and decreased gradually over time; initial high doses of baclofen, without tapering up to that amount, can cause side effects to be more severe. The maximum recommended daily dose of this medication is 100 mg unless careful medical supervision is provided. Small, frequent doses are generally prescribed rather than larger doses. It may take several days for baclofen to first take effect.

Sudden withdrawal from baclofen can lead to the following symptoms:

  • Anxiety and confusion
  • Psychosis
  • Convulsions
  • Tachycardia

To prevent these withdrawal symptoms, the dosage of baclofen should be decreased incrementally over a period of 1-2 weeks.

Baclofen may interact with other medications and substances, including alcohol, anesthetics, tricyclic antidepressants, antihypertensives, dopaminergics, lithium, memantine, and NSAIDS. Baclofen should be avoided during pregnancy, especially during the first three months of gestation, as the drug crosses the placental barrier. Very small quantities of baclofen can be passed to babies through breast milk, but amounts are minimal – low enough that no undesirable effects are typically expected.

Baclofen is absorbed quickly from the gastrointestinal tract, and peak concentration in the bloodstream occurs about 1-3 hours after oral administration of the medication. Baclofen’s half-life is 3-4 hours in plasma, and its shelf life is three years from the date of manufacture. Oral tablets of the medication also contain lactose, pregelatinised maize starch, maize starch, magnesium stearate, and water.

Are These Drugs Addictive?

  • Most Addictive Substances
  • Klonopin
  • Kratom
  • Marijuana
  • Morphine
  • Phenibut
  • Suboxone
  • Xanax

Baclofen Use in Addiction Treatment

Baclofen may treat alcohol and drug addiction by altering the chemical processes responsible for substance addiction.

According to an article from Pacific University, the chemical makeup of this medication may mimic gamma-aminobutyric acid (GABA), which has a calming effect on mood. This calming effect leads to an increase in dopamine levels, thereby lessening cravings for the addictive substance.

Baclofen is well tolerated by most people. Since the drug has shown promise in the treatment of alcohol and opioid addiction when assessed through clinical trials, off-label use of baclofen in addiction recovery continues to gain prominence. Additional clinical trials are needed to assess the efficacy of the medication for this purpose before it can be approved by the FDA for the treatment of substance addiction, although prescription of the drug for off-label use is allowed. The

Substance Abuse and Mental Health Services Administration(SAMHSA) states that they do not currently recommend the use of baclofen in clinical patient settings due to a lack of sufficient data demonstrating the medication’s effectiveness for the purpose of addiction treatment. While some success has been shown in this area, use of the drug is still considered experimental by SAMHSA.

An analysis of recent studies exploring the efficacy of baclofen for the treatment of addiction, published by Cochrane Database of Systematic Reviews, found that baclofen showed limited success in treating alcohol withdrawal syndrome, equal to the success shown by other drugs, such as diazepam. Slightly more success was shown in the treatment of opioid dependence. Clinical trials published in BMC Psychiatry have shown promising results in the use of baclofen for maintenance treatment of opioid dependence.

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High-dose baclofen for alcohol treatment

Oliver Ameisen, an associate professor of medicine and cardiologist at Weill Medical College of Cornell University, reported in Alcohol and Alcoholism that he successfully used high-dose baclofen as an alcohol treatment and achieved complete and prolonged suppression of symptoms of his own alcohol dependence (2005).

Ameisen had been diagnosed with alcohol dependence and comorbid anxiety disorder. He reports that his anxiety disorder preceded his addiction to alcohol. He had tried other medications for alcohol dependence with no success. Ameisen decided to try baclofen, a gamma-amino butyric acid receptor agonist that is used to control spasticity. Previous research showed that baclofen had reduced alcohol craving in alcohol dependent patients and suppressed cocaine self-administration in rats; baclofen has also been used to treat anxiety disorders. Previous animal research showed that the motivation-suppressing effect of baclofen was dose-dependent. Ameisen postulated that at high doses, baclofen might suppress alcohol craving.

Ameisen self-prescribed baclofen starting at 30 mg/day and increased by 20 mg increments every third day (with an additional 20 to 40 mg/day to combat craving). He notes that neurologists safely use up to 300 mg/day for controlling spasticity. After 5 weeks, he reached a dose of 270 mg/day and experienced suppression of alcohol craving. Ameisen reports that his symptoms of alcohol dependence were suppressed (for a total of nine months at the time of the report), and his anxiety was well controlled.

“At the end of my ninth month of complete liberation from symptoms of alcohol dependence, I remain indifferent to alcohol, “Ameisen wrote. Abstinence has become natural to me. I no longer plan my life around alcohol. Alcohol thoughts no longer occur. I undertook personal and professional projects, which I was unable to do so before as I had to anticipate consequences of unpredictable drinking episodes (canceling appointments when possible and blackouts). As taught in , I avoided places, situations, social settings, and vacations where alcohol might have been present. I no longer notice liquor sections in supermarkets. Some of these changes have been pointed out to me by relatives and friends. I no longer suffer anticipatory anxiety of relapse, of embarrassing or dangerous alcohol-related situations. I am no longer depressed about having an incurable stigmatizing disease. Liberation from symptoms of alcohol dependence substantially improved my self-esteem.”

“High-dose baclofen induced complete and prolonged suppression of symptoms and consequences of alcohol dependence, and relieved anxiety,” he continued. “This model, integrating cure and well-being, should be tested in randomized trials, under medical surveillance. It offers a new concept: medication-induced, dose-dependent, complete and prolonged suppression of substance-dependence symptoms with alleviation of comorbid anxiety.”

Although Ameisen reported success with high-dose baclofen and called for further trials, no trials have been reported at this time five years later. However, some trials have been conducted to test Ameisen’s model of baclofen therapy for cocaine addiction. Note that the discontinuation of baclofen itself may cause withdrawal symptoms similar to benzodiazepine or alcohol withdrawal symptoms, including hallucinations, confusion, agitation, insomnia, anxiety, depersonalization, and mood disturbances. Baclofen withdrawal symptoms are more likely with abrupt discontinuation.

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Reference

Ameisen, O. Complete and prolonged suppression of symptoms and consequences of alcohol-dependence using high-dose baclofen: a self-case report of a physician. Alcohol and Alcoholism. 2005; 40(2): 147-150.

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