Buprenorphine for Opioid Addiction

From 2000 to 2014, almost half a million people died of drug overdoses in the U.S.[1] Many of these were fatal opioid overdoses, which have quadrupled in the U.S. since 1999. This prompted President Barack Obama’s administration to declare an opioid abuse “epidemic.”[2]

There are several treatments for opioid addiction. One that has gained wide use in recent years is itself an opioid, buprenorphine. Buprenorphine works in the same way as prescription opioids and heroin but is weaker and so relieves the urge for opioids while creating less of the “high” that leads to addiction, overdose and withdrawal symptoms.[3]

Three of the four buprenorphine medications (BUNAVAIL, SUBOXONE, ZUBSOLV) approved to treat opioid addiction are taken orally and combined, in a single tablet or film, with another medicine, naloxone, which is intended to make the drug resistant to abuse by injection[4] or snorting[5]. The fourth medication, buprenorphine without naloxone (PROBUPHINE), is implanted under the skin.

Newer treatment, widespread use

The first buprenorphine medication for treating opioid addiction was approved by the Food and Drug Administration in 2002.[6] Before then, another opioid, methadone (METHADOSE), was the mainstay prescription treatment for opioid addiction. However, methadone for opioid addiction can be administered only in inpatient facilities or highly supervised clinics, while buprenorphine can be prescribed in a physician’s office[7] and is usually taken at home. Methadone also has potentially fatal cardiac side effects in certain patients.[8] Because of these disadvantages of methadone and due to the exploding opioid abuse epidemic in the country, buprenorphine has become increasingly popular and now outpaces methadone as a treatment of choice for opioid addiction. In 2012, 1 million people in the U.S. were prescribed SUBOXONE, more than three times as many as received methadone.[9]

Benefits and risks

Buprenorphine has been studied in a few small clinical trials, but based on these limited data, buprenorphine seems to be effective — probably as effective as methadone — in treating opioid addiction.[10],[11] But this benefit comes with several risks.

While the risk of abuse is lower with buprenorphine-containing products than with other oral, long-acting opioids,[12] it can still lead to dependence,[13] so physicians must be certified by the federal government before prescribing the drug.[14] The number of emergency department visits related to buprenorphine abuse and misuse rose from about 3,200 in 2005 to more than 30,000 in 2010, a nearly tenfold increase.[15] Opioid overdoses can cause people to stop breathing, leading to death.

Furthermore, buprenorphine has been associated with liver damage and is not recommended for patients with severe liver disease.[16] The National Institutes of Health concluded that liver injury mainly occurs when buprenorphine is taken in larger-than-recommended doses or abused by injecting into the bloodstream.[17] The labels for buprenorphine-containing products recommend that all patients have a blood test to check their liver function before, and periodically after, starting the drugs.

All opioids taken with certain antidepressants or migraine medications can cause a condition known as serotonin syndrome, with symptoms including hallucinations, rapid heart rate, fever and diarrhea.[18] In addition, opioids can lead to a rare but serious, potentially life-threatening condition in which the body does not produce enough cortisol, a hormone that helps the body respond to stress. The long-term use of opioids can also lead to reduced sex hormone levels, which can result in decreased sex drive, impotence or infertility. The simultaneous use of opioids and either alcohol[19] or another class of drugs known as benzodiazepines can increase the risk of serious side effects, including trouble breathing and death.[20]

What You Can Do

You should take buprenorphine only if you have been diagnosed as being addicted to opioids. To avoid withdrawal symptoms, you must not use any opioid for at least 12-24 hours before starting buprenorphine.[21]

It is critical that buprenorphine treatment be combined with intensive psychological and behavioral counseling to treat your addiction. Buprenorphine treatment also requires frequent (weekly or monthly) visits to your doctor to make sure that your treatment remains on course.[22] Your doctor will decide when you are ready to be weaned off of buprenorphine because you have a low risk of abusing opioids again.

Before you start buprenorphine, and periodically thereafter, you will need to have a blood test to see whether you have any signs of liver disease. Do not take buprenorphine if you have moderate or severe liver disease.

References

[1] Centers for Disease Control and Prevention. Opioid Basics: Understanding the epidemic. https://www.cdc.gov/drugoverdose/epidemic/. Accessed November 16, 2016.

[2] The White House. FACT SHEET: President Obama Proposes $1.1 Billion in New Funding to Address the Prescription Opioid Abuse and Heroin Use Epidemic. February 2, 2016. https://www.whitehouse.gov/the-press-office/2016/02/02/president-obama-proposes-11-billion-new-funding-address-prescription. Accessed December 1, 2016.

[3] Substance Abuse and Mental Health Services Administration. Buprenorphine. http://www.samhsa.gov/medication-assisted-treatment/treatment/buprenorphine. Accessed November 16, 2016.

[4] Food and Drug Administration. Zubsolv Medical Review. November 6, 2012. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204242Orig1s000MedR.pdf. Accessed November 15, 2016.

[5] Jones JD, Sullivan MA, Vosburg SK, et al. Abuse potential of intranasal buprenorphine versus buprenorphine/naloxone in buprenorphine-maintained heroin users. Addict Biol. 2015;20(4):784-98.

[6] Substance Abuse and Mental Health Services Administration. Buprenorphine. http://www.samhsa.gov/medication-assisted-treatment/treatment/buprenorphine. Accessed November 16, 2016.

[7] Ibid.

[8] Mallinckrodt Inc. Methadone label. October 2014. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=808a9d0b-720b-4034-a862-5122ff514608&audience=consumer. Accessed December 20, 2016.

[9] Svrluga S. The drug Suboxone could combat the heroin epidemic. So why is it so hard to get? Washington Post. January 13, 2015. https://www.washingtonpost.com/local/a-drug-called-suboxone-could-combat-the-heroin-epidemic-so-why-is-it-so-hard-to-get/2015/01/13/4135d08c-812e-11e4-9f38-95a187e4c1f7_story.html. Accessed November 16, 2016.

[10] Nielsen S, Larance B, Degenhardt L, Gowing L, Kehler C, Lintzeris N. Opioid agonist treatment for pharmaceutical opioid dependent people. Cochrane Database Syst Rev. 2016;(5):CD011117.

[11] Canadian Agency for Drugs and Technologies in Health. Suboxone versus Methadone for the Treatment of Opioid Dependence: A Review of the Clinical and Cost-effectiveness. CADTH Rapid Response Reports. 2013 Nov.; Ottawa (ON). https://www.cadth.ca/sites/default/files/pdf/htis/dec-2013/RC0495_Suboxone%20for%20opioid%20dependence_Final.pdf. Accessed November 15, 2016.

[12] Wiegand TJ, Le Lait MC, Bartelson BB, Dart RC, Green JL. Analysis of the abuse and diversion of the buprenorphine transdermal delivery system. J Pain. 2016;17(6):745-752.

[13] Indivior Inc. Label: SUBOXONE (buprenorphine and naloxone). June 2016. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a5edcf9-828c-4f97-b671-268ab13a8ecd&audience=consumer. Accessed December 20, 2016.

[14] Substance Abuse and Mental Health Services Administration. Medication-assisted treatment: Buprenorphine waiver management. http://www.samhsa.gov/medication-assisted-treatment/buprenorphine-waiver-management. Accessed November 16, 2016.

[15] Crane EH. Emergency Department Visits Involving Buprenorphine. The CBHSQ Report. Rockville (MD): Substance Abuse and Mental Health Services Administration; 2013.

[16] Indivior Inc. Label: SUBOXONE (buprenorphine and naloxone). June 2016. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a5edcf9-828c-4f97-b671-268ab13a8ecd&audience=consumer. Accessed December 20, 2016.

[17] National Institutes of Health. LiverTox. Buprenorphine, Buprenorphine/Naloxone. https://livertox.nlm.nih.gov/BuprenorphineBuprenorphineNaloxone.htm. Accessed November 15, 2016.

[18] Food and Drug Administration. Drug Safety Communication: FDA warns about several safety issues with opioid pain medicines; requires label changes. March 22, 2016. http://www.fda.gov/Drugs/DrugSafety/ucm489676.htmhttp://www.fda.gov/Drugs/DrugSafety/ucm489676.htm. Accessed November 15, 2016.

[19] Indivior Inc. Label: SUBOXONE (buprenorphine and naloxone). June 2016. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a5edcf9-828c-4f97-b671-268ab13a8ecd&audience=consumer. Accessed December 20, 2016.

[20] Food and Drug Administration. Drug Safety Communication: FDA warns about serious risks and death when combining opioid pain or cough medicines with benzodiazepines; requires its strongest warning. August 31, 2016. http://www.fda.gov/Drugs/DrugSafety/ucm518473.htm. Accessed November 15, 2016.

[21] Substance Abuse and Mental Health Services Administration. Buprenorphine. http://www.samhsa.gov/medication-assisted-treatment/treatment/buprenorphine. Accessed November 16, 2016.

[22] Substance Abuse and Mental Health Services Administration. Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction. 2004. https://www.ncbi.nlm.nih.gov/books/NBK64245/pdf/Bookshelf_NBK64245.pdf. Accessed November 16, 2016.