Suboxone.com - Opioid Dependence in the United States

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IMPORTANT INFORMATION:

On December 8, 2006, Federal legislation was passed allowing physicians to treat up to 100 opioid-dependent patients with Suboxone at any given time—a significant increase from the previous limit of 30 patients.

There may be doctors in your area participating in a study to measure opioid dependence treatment outcomes. Patients who meet the eligibility requirements to participate in this study can receive up to $225 in compensation to complete surveys about their treatment.

NOTE: This study is only open to patients not currently under the care of a physician for opioid dependence and are seeking a treatment provider.

Please call 1-866-455-8876 between 9:00 AM to 7:30 PM EST to get more information.

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Opioid Dependence in the United States

Over the past decade, the use of opioids, such as prescription painkillers and heroin, has grown significantly.¹ As the use of opioids increases, so does the number of people who abuse or become dependent on them. According to the National Survey on Drug Use and Health (NSDUH), in 2003 more than 1.5 million people were dependent on or abusing prescription painkillers or heroin.¹

(NOTE: Other surveys calculated the heroin-dependent population to be 4 to 5 times larger than what was reported in the 2003 NSDUH. Using these numbers, the size of the opioid abusing/dependent population in the United States is between 2.2 million and 2.4 million—or slightly bigger than the population of Houston, Texas.^1-3)

The problem of opioid dependence in this country is explored further in the sections listed below:

Prescription Painkillers—A Growing Presence
Opioid Use—The Changing Profile
Heroin—Hitting Closer to Home
Barriers to Treatment

Prescription Painkillers—A Growing Presence
Between 1990 and 2001, the number of people who used prescription painkillers recreationally for the first time grew by 335% to include almost 2.5 million people.¹

Annual Number of New Recreational Users of Prescription
Painkillers, Ages 12 and Older: 1970-2001¹

Over an 8-year period (1994-2002), emergency rooms saw a big jump in the number of admissions involving prescription painkillers, including:

Admissions involving oxycodone rose 450%⁴
Admissions involving hydrocodone rose 170%⁴

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Opioid Use—The Changing Profile
Through most of the 1980s, opioids were rarely used except when needed for medical reasons. The rising recreational use of drugs like marijuana and cocaine, for example, was considered much more important than the recreational use of opioids.¹

By the mid-1990s, however, the use of opioids for nonmedical reasons not only was increasing but also had become much more mainstream. This shift meant that new populations were now at risk, specifically, younger users^2,5:

44% of new recreational use of prescription painkillers in 2001 was by people under younger than age 18¹
The number of 18- to 25-year-olds admitted to treatment for prescription painkillers more than doubled between 1993 and 2002⁶

Frequency of Treatment Admissions for Prescription Painkillers
Among Persons Ages 18-25: selected years⁶

Women's use of opioids also has been increasing^5,7:

55% of new recreational users of prescription painkillers in 2001 were women¹
Between 1995 and 2002, the likelihood of a woman needing emergency medical care due to prescription painkillers doubled⁸

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Heroin—Hitting Closer to Home
Heroin has now spread to many communities where, until recently, it was virtually unheard of.^2,9,10 Even as heroin use falls in larger metropolitan areas, use in the suburbs continues to rise.^5,10,11

Heroin today is cheap and relatively pure—the national average is about 35% pure (compared with less than 5% pure during the 1960s and 1970s).^2,5,9,12 This purity increases heroin's appeal to new users, because¹²:

No needles—higher purity heroin can be smoked or snorted¹¹
Fewer obstacles—because smoking and snorting involve minimal preparation, they make it easier to use heroin "casually"^5,11-13
Fewer deterrents—many people unwilling to inject heroin are willing to snort or smoke heroin^5,11-13
Misinformation—many new users believe that heroin is less addictive when smoked or snorted^2,12

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Barriers to Treatment
Overall, opioid dependence accounted for 18% of all substance abuse treatment admissions in 2001, surpassing cocaine admissions for the 5th consecutive year.¹⁴

This figure is believed to understate the true size of the opioid dependence problem, because:

In several states, the number of people who want treatment is greater than the resources available to actually provide treatment¹⁵
The stigma attached to opioid dependence can be so overwhelming that thousands of patients every year choose to continue using opioids rather than risk possible exposure by receiving treatment^15,16
20% of patients who wanted help for substance abuse in 2001 did not seek treatment because of their fear of being stigmatized¹
Only about 15% of heroin-dependent persons are in treatment

As a result of these and other factors, in 2004, at least 1.2 million opioid-dependent patients in the United States are believed to be untreated.¹⁷

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References

1.	Substance Abuse and Mental Health Services Administration (SAMHSA). Results From the 2003 National Survey on Drug Use and Health: National Findings. Rockville, Md: Department of Health and Human Services, SAMHSA, Office of Applied Studies; 2004. NSDUH Series H—25, DHHS Publication No. SMA 04-3964.
2.	Stancliff S. Buprenorphine and the treatment of opioid addiction. The PRN Notebook. 2004;9:28-32.
3.	Infoplease. Population of the 20 largest U.S. cities. 1900-2003. Available at: http://www.infoplease.com/ipa/A0922422.html. Accessed April 6, 2005.
4.	SAMHSA. The DAWN Report: oxycodone, hydrocodone, and polydrug use, 2002. July 2004. Available at: http://www.oas.samhsa.gov/2k4/oxycodone/oxycodone.cfm. Accessed September 30, 2004.
5.	Community Epidemiology Work Group (CEWG). Advance report of findings presented at the 53rd CEWG meeting. Available at: http://www.drugabuse.gov/PDF/CEWG/AdvReport1202.pdf. Accessed September 30, 2004.
6.	SAMHSA. Quick Statistics From the Drug and Alcohol Services Information System. Available at: http://www.dasis.samhsa.gov/webt/tedsweb/tab_year.choose_year_web_table?t_state=US. Accessed October 19, 2004.
7.	Partnership for a Drug-Free America. Prescription medication abuse. Available at: http://www.drugfreeamerica.org/Templates/Prescription_Abuse.asp? ws=PDFA&vol=1&grp=Kids. Accessed August 10, 2004.
8.	SAMHSA. The DAWN Report: narcotic analgesics, 2002 update. September 2004. Available at: http://www.dawninfo.samhsa.gov/pubs_94_02/shortreports/files/DAWN_tdr_na2002.pdf. Accessed October 19, 2004.
9.	Klein A. Young and hooked: pure, cheap heroin luring more North Jersey teens. New Jersey Record. May 2, 2004:A-1, A-14-A-15.
10.	National Institute on Drug Abuse. Research Report series: heroin abuse and addiction. Printed October 1997. Reprinted September 2000. Available at: http://www.nida.nih.gov/ResearchReports/Heroin/Heroin.html. Accessed September 30, 2004.
11.	Epstein JF, Gfroerer JC. Heroin abuse in the United States. Office of Applied Studies, SAMHSA website. Available at: http://www.oas.samhsa.gov/NHSDA/Treatan/treana11.htm. Accessed July 29, 2004.
12.	California Department of Alcohol and Drug Programs. Fact sheet: facts and figures on youth heroin use. July 2004. Available at: http://www.adp.cahwnet.gov/FactSheets/Facts_and_Figures_on_Youth_Heroin_Use.pdf. Accessed September 30, 2004.
13.	Fiellin DA, O'Connor PG. Office-based treatment of opioid-dependent patients. N Engl J Med. 2002;347:817-823.
14.	Treatment Episode Data Set. 2001 Highlights. Available at: http://www.dasis.samhsa.gov/teds01/TEDS2K1High.htm. Accessed August 12, 2004.
15.	Ellen EF. Methadone proponents urge office-based treatment. Psych Times. January, 2001. Available at: http://www.medicineandbehavior.com/mb990801b.html. Accessed August 16, 2004.
16.	O'Connor A. New ways to loosen addiction's grip. The New York Times. August 3, 2004;sect F:1.
17.	Lucas GM. Buprenorphine in primary HIV care clinics: a big pill to swallow. The Hopkins HIV Report. 2004;16:5-7.

Important Safety Information

SUBOXONE^® (buprenorphine and naloxone) Sublingual Film (CIII) is indicated for maintenance treatment of opioid dependence as part of a complete treatment plan to include counseling and psychosocial support. Treatment should be initiated under the direction of physicians qualified under the Drug Addiction Treatment Act.

SUBOXONE Sublingual Film should not be used by patients hypersensitive to buprenorphine or naloxone.

SUBOXONE Sublingual Film can be abused in a manner similar to other opioids, legal or illicit. Clinical monitoring appropriate to the patient's level of stability is essential.

Chronic use of buprenorphine can cause physical dependence. A sudden or rapid decrease in dose may result in an opioid withdrawal syndrome that is typically milder than seen with full agonists and may be delayed in onset.

SUBOXONE Sublingual Film can cause serious life-threatening respiratory depression and death, particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other central nervous system (CNS) depressants (ie, sedatives, tranquilizers, or alcohol). It is extremely dangerous to self-administer nonprescribed benzodiazepines or other CNS depressants while taking SUBOXONE Sublingual Film. Dose reduction of CNS depressants, SUBOXONE Sublingual Film, or both when both are being taken should be considered.

Liver function should be monitored before and during treatment.

Death has been reported in nontolerant, nondependent individuals, especially in the presence of CNS depressants.

Children who take SUBOXONE Sublingual Film can have severe, possibly fatal, respiratory depression. Emergency medical care is critical. Keep SUBOXONE Sublingual Film out of the sight and reach of children.

Intravenous misuse or taking SUBOXONE Sublingual Film before the effects of full-agonist opioids (eg, heroin, hydrocodone, methadone, morphine, oxycodone) have subsided is highly likely to cause opioid withdrawal symptoms.

Neonatal withdrawal has been reported. Use of SUBOXONE Sublingual Film in pregnant women or during breast-feeding should only be considered if the potential benefit justifies the potential risk. Caution should be exercised when driving vehicles or operating hazardous machinery, especially during dose adjustment.

Adverse events commonly observed with the sublingual administration of SUBOXONE Sublingual Film are numb mouth, sore tongue, redness of the mouth, headache, nausea, vomiting, sweating, constipation, signs and symptoms of withdrawal, insomnia, pain, swelling of the limbs, disturbance of attention, palpitations, and blurred vision.

Cytolytic hepatitis, jaundice, and allergic reactions, including anaphylactic shock, have been reported.

This is not a complete list of potential adverse events associated with SUBOXONE Sublingual Film. Please see full Prescribing Information for a complete list.

To report an adverse event associated with taking SUBOXONE Sublingual Film, please call 1-877-782-6966. You are encouraged to report adverse events of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

SUBOXONE^® (buprenorphine HCl/naloxone HCl dihydrate) sublingual tablets (CIII) is indicated for the treatment of opioid dependence.

It is extremely dangerous to self-administer non-prescribed benzodiazepines or other depressants while taking SUBOXONE. A serious overdose and death may occur if benzodiazepines, sedatives, tranquilizers, antidepressants, or alcohol are taken at the same time as SUBOXONE.

SUBOXONE has potential for abuse and produces dependence of the opioid type, with a milder withdrawal syndrome than full agonists.

Cytolytic hepatitis and hepatitis with jaundice have been observed in the addicted population receiving buprenorphine.

Allergic reactions including bronchospasm, angioneurotic edema, and anaphylactic shock have been reported in patients taking buprenorphine.

There are no adequate and well-controlled studies of SUBOXONE (a Category C medication) in pregnancy.

Caution should be exercised when driving cars or operating machinery.

Always store buprenorphine-containing medications safely and out of the reach and sight of children. Destroy any unused medication appropriately.

The most commonly reported adverse events with SUBOXONE include: headache (36%, placebo 22%), withdrawal syndrome (25%, placebo 37%), pain (22%, placebo 19%), insomnia (14%, placebo 16%), nausea (15%, placebo 11%), and sweating (14%, placebo 10%). Please see full Prescribing Information for a complete list.

To report an adverse event caused by taking SUBOXONE, please call 1-877-782-6966. You are also encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

For information about SUBOXONE Film, please see full US Product Information for SUBOXONE (buprenorphine and naloxone) Sublingual Film (CIII)

For more about SUBOXONE Tablets, please see full US Product Information for SUBOXONE (buprenorphine and naloxone) sublingual tablets (CIII)

* Data on file, Reckitt Benckiser Pharmaceuticals Inc., Richmond, VA:

Patient preferred: Clinical trial participants preferred SUBOXONE Film over the SUBOXONE Tablet. Results from a questionnaire collected at discharge of a 13-week, multicenter, open-label safety trial. Patients were asked, "Based on your previous experience with SUBOXONE Tablets and your current experience with SUBOXONE Film, which product do you prefer?"

Dissolve time: The time required for both SUBOXONE Film and SUBOXONE Tablet dissolution is dependent on saliva quantity and is subject to individual variation, and dose and strength taken. Mean dissolution time for all doses tested (8 mg, 2 mg) was between 5 and 6.6 minutes for SUBOXONE Film and between 7 and 12.4 minutes for the SUBOXONE Tablet.

Taste: In a patient questionnaire, more than 71% of patients who have tried SUBOXONE Film rated the taste as neutral or better on a 10-point scale. Results from a questionnaire collected at discharge of a 13-week, multicenter, open-label safety trial. Patients were asked, "Please give this product (SUBOXONE Film) a score which shows how you would rate the flavor." 10=extremely pleasant and 1=extremely unpleasant.

Portability: Because each unit of SUBOXONE Film is individually packaged in a compact, child-resistant pouch, it's easy to carry with you. Remember to keep this medication out of the sight and reach of children, and take your prescription label along with you. If a child takes the medication, seek emergency care.

Child resistance: Meets the Consumer Product Safety Commission's standards for child resistance. During testing, 1 child out of 50 was able to open 2 or more pouches. After receiving instruction, the children's ability to open the pouches increased. It is important not to open the pouches in front of children.

^† Opioid-dependent patients who were on Buprenorphine-Medication Assisted Therapy (B-MAT) and engaged in the Here to Help program (completed 4 or more Care Coach calls) demonstrated improved adherence compared to control group for B-MAT. Data on file, Reckitt Benckiser Pharmaceuticals Inc., Richmond, VA.

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