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Naltrexone And Alcoholism Treatment
Treatment Improvement Protocol (TIP) Series 28

[Figures]

Figure 2-1: Information on Naltrexone for the Primary Health Care Provider

Figure 2-1
Information on Naltrexone for the Primary Health Care Provider

Naltrexone is an appropriate treatment for alcohol-dependent patients, including binge drinkers.
The only absolute medical contraindications are liver failure, acute infectious hepatitis, and current dependence on opioids or active opioid withdrawal. Elevated bilirubin levels, pregnancy, breast feeding, and use in adolescents are relative contraindications.
At the currently recommended dose of 50 mg daily, hepatic toxicity is very unlikely. Continued alcohol use is more likely than naltrexone to cause liver damage.
Providers should perform LFTs prior to treatment initiation and periodically during treatment.
Abstinence should be a desired goal for the patient; however, reductions in drinking may be an acceptable intermediate outcome. Failure to maintain complete abstinence is not necessarily a failure of treatment because there are many other areas of a patient's life that can improve, such as job performance, social relationships, and general physical health. This is similar to the goal of reducing high blood pressure; not all patients will have a total improvement of hypertension.
Naltrexone is likely to be most effective when used in combination with other forms of treatment for alcoholism, such as psychosocial interventions, and when the patient complies with both.

Figure 2-2: Absolute and Relative Contraindications for Naltrexone

Figure 2-2 Absolute and Relative Contraindications for Naltrexone
Absolute	Relative
Acute hepatitis Liver failure Chronic opioid dependence or current opioid use, especially methadone or LAAM^a Active opioid withdrawal (Note: The naltrexone-clonidine combination can be used in opioid withdrawal procedures.)	Significant hepatic dysfunction Anticipated need for opioids to treat an identified medical problem^b Pregnancy^c Breast feeding^c Use in adolescents^c
^aThis includes not only illegal opiates such as morphine or heroin, but also opioid-containing medications that are prescribed for managing pain and treating serious medical conditions such as heart disease, severe arthritis, sickle cell anemia, and recurrent congestive heart failure. ^bFor individuals who are taking naltrexone, prescription or over-the-counter analgesics, cough medicines, and pain medications that contain opioids--such as oxycodone hydrochloride (e.g., Percodan), hydrocodone bitartrate (e.g., Vicodin), and codeine (e.g., Robitussin A-C)--may not be effective. Naltrexone does not affect nonsteroidal anti-inflammatory drugs (e.g., Advil, Aleve), aspirin, or acetaminophen (e.g., Tylenol). Naltrexone blocks the effect of loperamide hydrochloride (Imodium) against diarrhea. Bismuth compounds (Pepto-Bismol) may be used for mild nausea or diarrhea, and octreotide acetate (Sandostatin) may be used for severe diarrhea, and ondansetron hydrochloride (Zofran) may be used for nausea and vomiting, especially with accidental naltrexone-precipitated opiate withdrawal. ^cUntil further research is done, due to the effects of naltrexone on hormonal status, especially growth hormone, luteinizing hormone, and prolactin.

Figure 2-3: Elements of Pretreatment Workup

Figure 2-3
Elements of Pretreatment Workup

Physical examination of the liver and thorough laboratory screening of liver function
Laboratory tests including
- Serum aminotransferases
- Total bilirubin
- Pregnancy test (urine or blood)
- Urine toxicology screen
Complete/updated medical history
Substance use/abuse history combined with a screening for signs and symptoms of recent narcotic use
Mental health/psychiatric status screening with a focus on anxiety, depression, psychosis, and level of cognitive functioning

Figure 2-4: Dosing Strategies for Starting Naltrexone Treatment ^a

Figure 2-4 Dosing Strategies for Starting Naltrexone Treatment^a
General Approach	Specialized Approach
For most patients 50 mg/day	For patients judged likely to be at risk for adverse effects, such as younger patients and those with shorter durations of abstinence. 12.5 mg/day or 25 mg/day for a few days, then gradually increase to 50 mg daily. This dose can be divided into two doses, each with a meal if desired.
Note: If severe common adverse effects occur after the initial dose, stop the medicine, then resume at a lower dose 1 or 2 days after the symptoms have subsided.
^aTreatment with naltrexone should be tailored to patient needs. Dosing strategies described are examples of models used by some programs; they do not represent definitive guidelines.

Figure 2-5: Safety Identification Card

Figure 2-5
Safety Identification Card

Side 1

TO MEDICAL PERSONNEL TREATING ME IN AN EMERGENCY: This patient is taking the oral opioid antagonist reVia^®, formerly known as Trexan^® (naltrexone hydrochloride).

In an emergency situation in patients receiving fully blocking doses of reVia^®,a suggested plan of management is regional anesthesia, conscious sedation with a benzodiapine, use of non-opioid analgesics, or general anesthesia.

In a situation requiring opioid analgesia, the amount of opioid required may be greater than usual, and the resulting respiratory depression may be deeper and more prolonged.

A rapidly acting opioid analgesic that minimizes the curation of respiratory depression is preferred. The amount of analgesia administered should be titrated to the needs of the patient. Non-receptor mediated actions may occur and should be expected (e.g., facial swelling, itching, generalized erythemia, or bronchoconstriction), presumably due to histamine release.

Irrespective of the drug chosen to reverse reVia^® (naltrexone hydrochloride) blockade, the patient should be monitored closely by appropriately trained personnel in a setting equipped and staffed for cardiopulmonary resuscitation.

For medical emergencies, call your regional Poison Control Center. Further information may be obtained by calling: 1-800-4PHARMA.

Side 2

The name and telephone number of physician who prescribed reVia^® (naltrexone hydrochloride).

Physician's name: ___________________________________________________________________

Physician's telephone: _______________________________________________________________

Patient's name: _____________________________________________________________________

Patient's telephone: _________________________________________________________________

Date treatment was initiated: _________________________________________________________

Figure 3-3: Opiates Versus Opioids

Figure 3-3
Opiates Versus Opioids

Opiates such as morphine and heroin are derived from opium, which is harvested from the opium poppy (Papaver somiferum). Through their research on opiate addiction, scientists discovered specific sites in the central nervous system where opiates attach and exert their effect. These sites are called opioid receptors. Subsequent to this discovery, scientists were able to identify the naturally occurring chemicals produced by the body that also attach to opioid receptors.
In this document, the term opiate refers to drugs like morphine and heroin, whereas the term opioid refers to naturally occurring chemicals such as enkephalins and endorphins (endogenous opioids) that exert opiate-like effects by interacting with central nervous system opioid receptors.

Figure 4-1: Outcomes for Naltrexone- and Placebo-Treated Subjects

Figure 4-1 Outcomes for Naltrexone- and Placebo-Treated Subjects
Outcome	Naltrexone (n = 35)	Placebo (n = 35)
Completion rate	69%	60%
Sampled alcohol	46%	57%
Drinking days	1.6%	8.3%
Total relapsing	23%	54%
Relapse among those who "slipped"	50%	95%
Mean craving score at termination (0-9)	1.41	3.42
Source: Volpicelli et al., 1992.

Figure B-2: Federal and Private Web Sites

Figure B-2
Federal and Private Web Sites

Substance Abuse and Mental Health Services Administration (SAMHSA) Sites

SAMHSA Home Page: http://www.samhsa.gov/
SAMHSA Weekly Report: http://www.samhsa.gov/wklyrpt.htm
Managed Behavioral Care Meetings and Conferences: http://www.samhsa.gov/mc/mcmtgs.htm
Center for Substance Abuse Treatment (CSAT): http://www.samhsa.gov/csat/csat.htm
Addiction Technology Transfer Centers (ATTC): http://views.vcu.edu/nattc/
National Evaluation Data and Technical Assistance Center (NEDTAC): http://www.calib.com/nedtac/index.htm
National Technical Center for Substance Abuse Needs Assessment: http://www.tiac.net/users/ntc/
CSAT by Fax (A Special Edition of CESARFAX): http://ncadi.samhsa.gov/daatpp.htm
Center for Substance Abuse Prevention (CSAP): http://www.samhsa.gov/csap/index.htm
Prevline: http://ncadi.samhsa.gov/
National Clearinghouse for Drug and Alcohol Information Online Catalog: http://ncadi.samhsa.gov/pubs/catalog/
Center for Mental Health Services (CMHS): http://www.samhsa.gov/cmhs/cmhs.htm
The Knowledge Exchange Network (KEN): http://mentalhealth.samhsa.gov/

Other Federal Sites

Department of Health and Human Services (HHS): http://www.os.dhhs.gov:80/
Healthfinder: http://www.healthfinder.gov/
HHS Partner Gateway: http://www.os.dhhs.gov:80/partner/
Drug Enforcement Administration: http://www.usdoj.gov/dea/index.htm
Food and Drug Administration (FDA): http://www.fda.gov/fdahomepage.html
Health Care Financing Administration (HCFA): http://www.hcfa.gov/
Higher Education Center for Alcohol and Other Drug Prevention: http://www.edc.org/hec/
Justice Information Center (NCJRS): http://www.ncjrs.org/
Library of Congress: http://lcweb.loc.gov/homepage/lchp.html
National Institute on Alcohol Abuse and Alcoholism (NIAAA): http://www.niaaa.nih.gov/
National Institute on Drug Abuse (NIDA): http://www.nida.nih.gov/
Drug Abuse Warning Network (DAWN): http://ncadi.samhsa.gov/pubs/dawn/index.htm
Monitoring the Future: http://www.isr.umich.edu/src/mtf/index.html
ONDCP Drugs and Crime Clearinghouse: http://www.ncjrs.org/drgshome.htm
White House Social Statistics Briefing Room: http://www.whitehouse.gov/fsbr/ssbr.html

Private Sites

Alcoholics Anonymous World Services: http://www.alcoholics-anonymous.org/
American Medical Association's Resources on Alcohol and Other Substances: http://www.ama-assn.org/special/aos/resource.htm
Addiction Research Foundation: http://www.arf.org/
American Psychiatric Association: http://www.psych.org/
American Psychological Association: http://www.apa.org/
American Psychological Association's Addictions Newsletter: http://www.kumc.edu/addictions_newsletter/
American Society of Addiction Medicine: http://www.asam.org
Center for Education and Drug Abuse Research (CEDAR): http://www-eval.srv.cis.pitt.edu/~mmv/cedar.html
Center for Substance Abuse Research (CESAR): http://www.bsos.umd.edu/cesar/cesar.html
International Certification and Reciprocity Consortium/Alcohol and Other Drug Abuse: http://www.realsolutions.org/icrc.htm
Internet Alcohol Recovery Center: http://www.med.upenn.edu/recovery
Join Together Online: http://www.jointogether.org/jtc
Monitoring the Future: http://www.isr.umich.edu/src/mtf/index.html
Narcotics Anonymous: http://www.wsoinc.com/basic.htm
National Association of Alcoholism and Drug Abuse Counselors: http://www.naadac.org/index.html
National Association of Social Workers (NASW): http://www.naswdc.org
National Association of State Alcohol and Drug Abuse Directors (NASADAD): http://www.nasadad.org/default.htm
National Center on Addiction and Substance Abuse (CASA): http://www.casacolumbia.org/home.htm
National Families in Action (NFIA): http://www.emory.edu/NFIA/
National Inhalant Prevention Coalition: http://www.inhalants.org/
National Treatment Consortium, Inc.: http://www.ntc-usa.org/index.html<
Partnership for a Drug-Free America: http://www.drugfreeamerica.org/
Research Society on Alcoholism (RSA): http://www.sci.sdsu.edu/RSA/
Research Institute on Addictions: http://www.ria.org/
The Web of Addictions: http://www.well.com/user/woa/

Figure C-1: Critical Challenges to Effective Use of Research Findings

Figure C-1
Critical Challenges to Effective Use of Research Findings

Lack of awareness--potential users do not know about the innovation.
Lack of conviction--potential users are not certain that the innovation will work in their setting without unreasonable costs or adverse effects.
Lack of resources--potential users may not have access to needed funding, materials, or trained personnel for adopting the innovation.
Lack of preparation for change--which can be threatening to staff and difficult to implement, particularly in large and complex organizations.

Source: Adapted from Backer, 1991.

Figure C-2: Characteristics of an Organization That Is Likely to Adopt an Innovation

Figure C-2
Characteristics of an Organization That Is Likely to Adopt an Innovation

Organizational climate that supports the concept of change, creativity, and innovation through open communication among personnel, with all levels participating in the making of decisions; collegial endorsement of help-seeking and problem-solving; available time for consideration of innovation
Organizational size and structure with some emphasis on self-monitoring and assessment to detect troubles, without being too big or too complex for rapid assimilation of change or too bureaucratic, complacent, or conforming to tradition
Organizational affluence and capacity that is sufficient to risk innovation and provide the resources for implementing change
Leaders in the organization who are attuned to change, politically astute, and respectful of different professional disciplines
Professionalism, age, and security of staff members who look forward to innovations; are not threatened by change; and are willing to entertain, discuss, and attempt new procedures or technologies
Relationship to the community and the consumer constituency with a demonstrated ability to lead and a capacity for autonomy rather than vulnerability and immediate capitulation to outmoded traditions

Source: Adapted from National Institute of Mental Health, 1971.

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Español: (877) 767-8432

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Naltrexone And Alcoholism Treatment Treatment Improvement Protocol (TIP) Series 28

[Figures]

Figure 2-4: Dosing Strategies for Starting Naltrexone Treatment a

Naltrexone And Alcoholism Treatment
Treatment Improvement Protocol (TIP) Series 28

Figure 2-4: Dosing Strategies for Starting Naltrexone Treatment ^a