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5. Answers to Frequently Asked Medication Questions2

 

(2 Adapted from Rounsaville, B.J.; O’Malley, S.; and O’Connor, P. “Guidelines for the Use of Naltrexone in the Treatment of Alcoholism.” New Haven, CT: APT Foundation, 1995. Reproduced with the permission of DuPont Pharma.)

5.1. Naltrexone

 

1. What is naltrexone, and how does it work?

 

Naltrexone is a medication that blocks the effects of drugs known as opiates, or narcotics (a class that includes morphine, heroin, or codeine). It competes with these drugs for opioid receptors in the brain. Originally used to treat dependence on opiate drugs, it now has also been approved by the U.S. Food and Drug Administration (FDA) as treatment for alcohol dependence. People who are dependent on opiate drugs, such as heroin or morphine, must stop their drug use at least 7 days prior to starting naltrexone. Some people should not take naltrexone, such as those suffering from chronic pain who rely on opioid painkillers or people with liver failure or acute hepatitis.

 

Although the precise mechanism of action for naltrexone’s effect is unknown, reports from successfully treated patients suggest the following three kinds of effects:
  1. Naltrexone can reduce a patient’s urge or desire to drink.

  2. Naltrexone helps patients remain abstinent.

  3. Naltrexone can interfere with the patient’s desire to continue drinking more if he/she slips and has a drink.

 

In most clinical trials evaluating the effectiveness of naltrexone, subjects who received naltrexone were significantly more successful in remaining abstinent and in avoiding relapse than were those receiving an inactive placebo pill.

2. Is it possible to become addicted to naltrexone?

No. Naltrexone is not habit forming or a drug of abuse. It does not cause users to become physically or psychologically dependent.

3. What are the side effects of naltrexone?

In a large open-label safety study on naltrexone, conducted by Dupont Pharma in 570 individuals with alcoholism, the most common side effects affected only a small minority of people; they included the following:

  • Nausea (10 percent of participants)

  • Headache (7 percent of participants)

  • Depression (5 to 7 percent of participants)

  • Dizziness (4 percent of participants)

  • Fatigue (4 percent of participants)

  • Insomnia (3 percent of participants)

  • Anxiety (2 percent of participants)

  • Sleepiness (2 percent of participants).

 

These side effects were usually mild and of short duration. Patients usually report that they are largely unaware of being on naltrexone. Naltrexone usually has no psychological effects, and users do not feel either “high” or “down.” Naltrexone can have toxic effects on the liver. A patient receives blood tests of liver function prior to the onset of treatment and regularly during treatment to determine if he/she should take it at all, if he/she should stop taking it, or if he/she experiences the relatively rare side effect of liver toxicity. Patients should report any side effects to their medical clinician.

4. What will happen if a patient drinks alcohol while taking naltrexone?

Naltrexone does not reduce the effects of alcohol that impair coordination and judgment. Naltrexone may reduce the feeling of intoxication and the desire to drink more, but it will not cause a severe physical response to drinking.

5. Is it all right to take other medications with naltrexone?

Patients should carry a card explaining that they are taking naltrexone, and it should instruct medical staff on pain management. Naltrexone does not reduce the effectiveness of local and general anesthesia used with surgery. However, it does block pain relief from opiate medications. Many pain medications that are not opiates are available. Patients having elective surgery should stop taking naltrexone at least 72 hours beforehand.

The major active effect of naltrexone is on opiate (narcotic) drugs, which is one class of drugs used primarily to treat pain but is also found in some prescription cough preparations. Naltrexone will block the effect of normal doses of this type of drug. There are many nonnarcotic pain relievers patients can use while on naltrexone.

Otherwise, naltrexone is likely to have little impact on other medications patients commonly use such as antibiotics, nonopioid painkillers (e.g., aspirin, acetaminophen/Tylenol, ibuprofen/Motrin/Advil), and allergy medications. Patients should inform their medical clinician of the medication they are currently taking so that possible interactions can be evaluated. Because the liver breaks down naltrexone, other medications that can affect liver function may affect the dose of naltrexone.

6. What will happen if a patient becomes pregnant while taking naltrexone?

Patients with the biological potential to have a child should be using an effective method of birth control while taking naltrexone. However, if they miss a menstrual period, they should report this to their medical clinician at once and take a pregnancy test.

If a patient becomes pregnant, she will discontinue the medication. The medical clinician should continue to ask after her health throughout her pregnancy as well as the health of her baby after delivery.

7. Should naltrexone be taken with a meal?

There is no information that taking naltrexone with or without meals makes any difference in effect.

8. What happens if a patient stops taking naltrexone suddenly?

Naltrexone does not cause physical dependence, and patients can stop taking it at any time without experiencing withdrawal symptoms.

9. If patients take naltrexone, does it mean that they don’t need other treatment for alcohol dependence?

No. Research studies have shown that naltrexone was most effective when it was combined with treatment from professionals and/or mutual-support groups.

10. What is the relationship of naltrexone to AA and other support groups?

There is no contradiction between participating in support groups and taking naltrexone. In fact, one multisite study showed that naltrexone-taking subjects who attended mutual-support groups, such as AA, had better outcomes. It is most likely to be effective for patients whose goal is to stop drinking altogether. If other mutual-support group members caution against taking any medications, patients should refer them to the pamphlet “The AA Member—Medications and Other Drugs,” which explicitly states that AA members should not “play doctor” and advise others on medication provided by legitimate, informed medical practitioners or treatment programs.

5.2. Acamprosate3

 

(3 Adapted from Mason, B.J., and Goodman, A.M., Brief Intervention and Medication Compliance Procedures—Therapist’s Manual, 1997. http://www.alcohol-free.com.)

1. What is acamprosate, and how does it work?

Acamprosate is a new, investigative medication for treatment of alcohol dependence approved in several European countries, and it is currently being studied in clinical trials in the United States. It is thought to reduce the urge for alcohol by working directly on certain neurotransmitters in the brain (chemicals that transmit information between nerve cells) whose balance has been disturbed because of regular, heavy drinking.

Although acamprosate can be used in the United States only with permission of the FDA, it has been available in Europe since 1989 and has recently been approved for marketing by prescription in more than 12 European countries, including Belgium, France, Germany, Ireland, Italy, the Netherlands, Spain, Switzerland, and the United Kingdom. It is estimated that more than 1 million patients have been treated with acamprosate since it became available.

2. Is acamprosate addictive?

No. Acamprosate is not habit forming or a drug of abuse. It does not cause users to become physically or psychologically dependent.

3. What are the side effects of acamprosate?

Like virtually all medications, acamprosate can cause side effects, but these are usually minor and go away as patients continue to take the medication. In European controlled clinical trials, the only types of symptoms that were consistently more common in subjects taking acamprosate than in subjects taking placebo were stomach symptoms. These were usually mild, tended to occur when subjects first started taking the medication, and consisted primarily of loose bowel movements or mild diarrhea. Some subjects also had changes in their sex drive—sometimes this was increased and sometimes decreased, but there was no definite pattern. As with many drugs, sometimes people on acamprosate develop skin rashes or itching. In earlier studies, subjects on acamprosate and those on placebo both experienced equal amounts of this type of symptom. Patients should tell their medical clinician of any side effects.

4. What will happen if a patient drinks alcohol while taking acamprosate?

Acamprosate does not change the way the body metabolizes alcohol, so acamprosate will not make patients feel sick if they drink (i.e., it does not work like Antabuse). In addition, there is no evidence of an added effect of alcohol if the patient drinks while taking acamprosate.

5. Is it okay to take other medications with acamprosate?

Because acamprosate is eliminated exclusively by the kidneys, drugs that may be toxic to the kidneys, such as aminoglycoside antibiotics (gentamycin and amikacin), should be avoided. Patients should inform their medical clinician of whatever medication they are currently taking so that possible interactions can be evaluated.

6. What will happen if a patient becomes pregnant while taking acamprosate?

Patients with the biological potential to have a child should be using an effective method of birth control while taking acamprostate. However, if they miss a menstrual period, they should report this to their medical clinician at once and take a pregnancy test.

If a patient becomes pregnant, she will discontinue the medication. The medical clinician should continue to ask after her health throughout her pregnancy as well as the health of her baby after delivery.

Even though acamprosate should not be used during pregnancy, animal studies have not shown any ill effects on either the course of pregnancy or on the offspring, nor is there any evidence from animal studies that acamprosate causes birth defects.

7. Should acamprosate be taken with a meal?

Acamprosate can be taken with food, but food does decrease the amount of medication that the body absorbs. Gastrointestinal symptoms may decrease by taking the medication with food.

8. Is it all right to crush the pills?

Acamprosate pills should not be crushed because they have an enteric coating. Destroying this coating can lead to a worsening of gastrointestinal side effects.

9. What happens if a patient stops taking acamprosate suddenly?

Acamprosate does not cause physiological withdrawal symptoms when it is stopped.

10. What happens if patients miss a dose?

If patients miss a dose of acamprosate, they should not take it simultaneously with the next scheduled dose; there should be a minimum of 2 hours between doses. If this is not feasible, they should not take the skipped dose. Instead, they should wait until their next scheduled dose and take only that dose.

11. If patients take acamprosate, does it mean that they don’t need other treatment for alcohol dependence?

 

No. Research has shown that acamprosate was most effective when it was combined with treatment from professionals and/or mutual-support groups.

12. What is the relationship of acamprosate to AA and other mutual-support groups?

There is no contradiction between participating in support groups and taking acomprosate. It is most likely to be effective for patients whose goal is to stop drinking altogether. If other mutual-support group members caution against taking any medications, patients should refer them to the pamphlet “The AA Member—Medications and Other Drugs,” which explicitly states that AA members should not “play doctor” and advise others on medication provided by legitimate, informed medical practitioners or treatment programs.