BULLETIN INTELLIGENCE

U. S. D E P A R T M E N T O F J U S T I C E

Background

Currently, the drug most commonly used in opiate addiction therapy in the United States is methadone, a Schedule II synthetic opiate. Methadone 

helps addicted individuals to stop abusing opiates 

by reducing opiate cravings and symptoms of withdrawal; however, there are several disadvantages to 

methadone-based opiate addiction therapy. Methadone can be prescribed only in licensed methadone 

treatment clinics, and patients must deal with the 

stigma attached to making daily trips to a methadone clinic. Also, these clinics commonly are 

located in or near urban centers, so patients in rural 

areas must drive long distances each day to obtain 

methadone. Finally, methadone abuse is increasing 

throughout the Northeast region, where abuse of 

heroin and other opiates is common, and increasingly is a factor in overdose deaths. 

In a move away from clinic-based therapy, the 

Drug Addiction Treatment Act of 2000 (DATA) 

passed by Congress in 2000 allows physicians who 

receive specialized training to treat opiate addiction 

in their offices with Schedule III, IV, and V medications approved by the Food and Drug Administration (FDA) specifically to treat opiate addiction. 

However, at the time DATA 2000 was passed, no 

medications had yet been approved by FDA for 

that purpose.

Buprenorphine: Potential for Abuse

Product No. 2004-L0424-013 SEPTEMBER 2004

Within the past 2 years buprenorphine—a Schedule III 

drug—has been made available for use in opiate addiction 

therapy. Two formulations of the drug are used in such 

therapy. Subutex, which is pure buprenorphine, is designed 

to be used in the initial stages of addiction treatment. 

Suboxone, which contains an antiabuse component, is 

designed to be used in the maintenance stage of treatment. 

Both block the effects of opiates while reducing opiate 

cravings and easing withdrawal symptoms. Buprenorphine 

is the only opiate addiction therapy drug that can be 

prescribed in a physician’s office; others must be 

dispensed in a clinic. This method of distribution is 

advantageous to many opiate addiction therapy patients 

because it is more convenient and less stigmatizing than 

clinic-based therapy, which typically involves methadone. 

Like methadone, however, buprenorphine is susceptible to 

abuse. Despite safety measures in place to guard against 

diversion of the drug, illegal distribution and abuse of 

buprenorphine have been reported in the United States, 

primarily in the Northeast region.

NDIC
Buprenorphine: Potential for Abuse

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On October 8, 2002, FDA approved buprenorphine in two formulations, Subutex and Suboxone, 

for use in opiate addiction therapy. Subutex 

(buprenorphine hydrochloride) is used in the initial 

stages of therapy while Suboxone (buprenorphine 

hydrochloride and naloxone hydrochloride) is used 

in the maintenance stage. Today, only these two formulations of buprenorphine meet DATA 2000 specifications; therefore, buprenorphine is the only drug 

that can be prescribed in a physician’s office to treat 

opiate addiction. (A third, Buprenex, is marketed as 

a pain relief medication that cannot be used to treat 

opiate addiction.) While most commonly used to 

treat addiction to heroin, buprenorphine can be 

used to treat addiction to any type of opiate, including oxycodones such as OxyContin and Percocet. 

Safeguards were put in place before buprenorphine was made available to the public because of 

widespread pharmaceutical diversion and increased 

prescription drug abuse in the nation. In fact, Suboxone was designed specifically to meet FDA requirements for a more diversion-proof drug for use in 

opiate addiction therapy and is available only in the 

United States. The naloxone contained in Suboxone 

guards against abuse—if an abuser crushes and 

injects or snorts the Suboxone tablet, the naloxone in 

it precipitates withdrawal symptoms. Naloxone 

(Narcan) reverses the effects of opiates. Further, in 

2002 the Drug Enforcement Administration (DEA) 

reassessed the potential for abuse of, diversion of, 

and addiction to buprenorphine and rescheduled it 

from a Schedule V drug to a Schedule III drug, thus 

increasing the penalties for illegally obtaining, possessing, or abusing buprenorphine.

To further safeguard buprenorphine from diversion, physicians prescribing the drug in either of the 

formulations approved for treating opiate addiction 

must become certified by attending a special training course and submitting their qualifications to the 

Substance Abuse and Mental Health Services 

Administration (SAMHSA). Physicians also must 

agree to refer patients for drug addiction counseling. 

After registering with SAMHSA, physicians 

receive a special identification number from DEA 

that appears on all buprenorphine prescriptions they 

administer. The DEA-issued identification number 

assigned to each certified physician aids law 

enforcement and antidiversion officials in tracking 

any diversion of the drugs. 

Physicians prescribing buprenorphine therapy 

must maintain a log of all patients using Subutex 

and Suboxone and record the medication that has 

been prescribed to them. The medical records of 

these patients are subject to periodic DEA and 

FDA review. FDA also has stipulated that the manufacturer of Subutex and Suboxone, Reckitt 

Benckiser Pharmaceuticals, must investigate any 

reports of diversion. 

More than 1,700 physicians or group practices 

in the United States—over 700 located in the Northeast—are certified to prescribe buprenorphine. Physicians currently are prohibited from prescribing 

Subutex and Suboxone to more than 30 patients at 

any given time. The 30-patient limit also applies to 

group practices. For example, a group practice of 

three certified physicians may prescribe Subutex 

and Suboxone to only 30 patients, not 90. However, 

Congress is considering the Drug Addiction Treatment Expansion Act of 2003. This legislation, if 

passed, will amend DATA 2000 by lifting the 30-

patient limit imposed on group practices and allowing each physician in a group practice to prescribe 

buprenorphine to 30 patients. 

Effects

Buprenorphine is a derivative of thebaine, an 

extract of opium. The drug is an opioid (synthetic 

opiate) partial agonist and thus can produce the 

euphoria, analgesia, and sedation associated with 

opiates; however, while it stimulates the same brain 

receptors as full opiate agonists such as heroin and 

morphine, buprenorphine produces a lesser degree 

of sedation and respiratory depression than those 

drugs and causes no significant impairment of cognitive or motor skills. Like methadone, buprenorphine reduces cravings for heroin and other opiates 

and reduces withdrawal symptoms, thus helping 
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addicted individuals to stop abusing opiates. Also 

like methadone, buprenorphine blocks the effects of 

heroin by binding to the same opiate receptors as 

heroin; consequently, opiate addicts who use 

buprenorphine are not able to get a high from heroin.

Buprenorphine also has a “ceiling effect” 

whereby increased doses of the drug do not produce 

increased effects after a certain point, or ceiling. In 

fact, high doses of the drug can actually precipitate 

withdrawal symptoms in opiate addicted individuals. 

Because of this ceiling effect, buprenorphine is less 

susceptible to abuse than other opiates; however, 

because high doses of the drug can cause withdrawal 

symptoms, buprenorphine is not as effective as methadone in treating severely opiate-addicted individuals 

who require larger doses of opiates in order to maintain treatment therapy. SAMHSA advises that the 

best candidates for buprenorphine therapy are those 

patients receiving 30 milligrams or less of methadone. Buprenorphine is estimated to be effective for 

approximately one-half to two-thirds of the opiate 

abuser population.

Advantages

The use of Subutex and Suboxone in opiate 

addiction therapy is likely to become more common 

because of several advantages. Buprenorphine can 

be prescribed by a local doctor and obtained from a 

local pharmacy, providing patients with convenient 

access to treatment. Further, if DATA 2003 is 

passed, the number of patients that can be treated by 

group practices will increase. Because patients can 

visit their local doctors, buprenorphine therapy is 

far more discreet, making it preferable for many 

patients who must deal with the stigma attached to 

making daily trips to a methadone clinic. This treatment option also is more convenient than methadone therapy for many abusers who would 

otherwise have to drive long distances each day to 

obtain methadone. Further, buprenorphine therapy 

can provide treatment in rural areas with inadequate 

access to treatment and in areas where methadone 

clinics have reached full capacity.

While it is possible to overdose on buprenorphine, it is safer than methadone because of its ceiling effect and decreased degree of respiratory 

depression. Also, because of the various safeguards 

in place, buprenorphine is more difficult to divert 

than methadone. The abuse of methadone poses a 

growing threat as evidenced by increasing mortality rates associated with it, whether diverted or 

A New Form of Buprenorphine legally prescribed. (See text box.) 

Administration

A new, extended-release formulation of 

buprenorphine, called a depot formulation, 

currently is being developed. This depot 

formulation is an injectable solution that contains 

tiny biodegradable capsules of buprenorphine. 

As the capsules disintegrate, they slowly release 

the drug over several weeks. This new 

formulation of buprenorphine is designed for 

administration in a physician’s office once every 

4 to 6 weeks and could further safeguard against 

diversion by eliminating the need for patients to 

possess buprenorphine in tablet form.

Methadone Overdose Deaths 

The abuse of methadone has contributed to an 

increase in overdose deaths, particularly in the 

Northeast region. For example, medical 

examiner data indicate that methadone is 

increasingly involved in overdose deaths in 

Maine. The number of overdose deaths in Maine 

where methadone was listed as the cause of 

death fluctuated, but increased overall from 4 in 

1997 to 14 in 2001. In the first 6 months of 2002, 

methadone was listed as the cause of death in 

18 deaths. Furthermore, methadone appeared 

as a factor in 33 percent of all accidental 

overdose deaths in Maine from 1997 through 

2003, one of the two highest percentages of all 

drugs during that period. 
Buprenorphine: Potential for Abuse

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Diversion

Buprenorphine is a synthetic opiate and produces 

the euphoric effects sought by opiate abusers; therefore, it is susceptible to abuse in both of the forms 

approved for treating opiate addiction. Subutex, the 

form that does not contain naloxone, is more vulnerable to abuse because it can be crushed and injected 

or snorted without causing withdrawal symptoms in 

the abuser. The FDA recommends that physicians 

limit the use of Subutex to supervised administration 

sessions; however, physicians are not required to do 

so, creating opportunities for Subutex diversion. 

Subutex has been prescribed legally for years in 

some foreign countries, where its diversion for illicit 

use is common. There are lucrative black markets for 

diverted Subutex in Germany, New Zealand, and the 

United Kingdom. In France, India, and Scotland, 

where buprenorphine is far more common in opiate 

addiction therapy than methadone, many individuals 

are addicted to Subutex. Suboxone is not available in 

these countries.

Suboxone also can be diverted and abused; 

however, it is more likely to be abused by individuals who are addicted to low doses of opiates since it 

can precipitate withdrawal symptoms in high 

doses. The naloxone in Suboxone guards against 

abuse by causing withdrawal symptoms in abusers 

who crush and either inject or snort the drug; however, law enforcement and pharmacist reporting 

indicates that Suboxone is being abused successfully when snorted.

Using buprenorphine and heroin in combination does not produce increased effects, but if 

buprenorphine and methadone are abused together, 

the effects of both drugs are enhanced. Consequently, diverted buprenorphine may be attractive 

to patients currently using methadone for opiate 

addiction therapy.

Despite controls designed to make buprenorphine diversion-proof, there have been reports of 

buprenorphine diversion throughout the United 

States, primarily in the Northeast region.

• Chittenden County, Vermont. A pharmacist in 

this area reports that Suboxone is being diverted 

and sold for $25 per 8-milligram tablet. Abusers 

are grinding the tablets and snorting them.

• Washington County, Maine. The Washington 

County Sheriff’s Office reports that buprenorphine is being diverted in that area and sold for 

$50 per tablet. The size of the tablet is unknown, 

and it is unclear whether Subutex or Suboxone 

tablets are being diverted in this case.

• Pennsylvania. The Pennsylvania Department 

of Health reports that diverted Subutex and 

Suboxone are being illegally distributed on 

the street. Specific locations have not been 

identified.

Outlook

It is unlikely that buprenorphine will render 

methadone therapy obsolete because it is not as 

effective in patients who require large doses of opiates in maintenance therapy. However, buprenorphine can provide opiate addiction therapy to 

individuals addicted to lower doses of opiates, to 

those in rural areas with inadequate access to treatment, and to those in areas where methadone clinics 

have reached full capacity. With more physicians 

obtaining certification to prescribe buprenorphine 

every day, this form of therapy has the potential to 

become as common as methadone therapy.

Because of its ceiling effect and ability to precipitate withdrawal symptoms if taken in high 

doses, buprenorphine is more susceptible to abuse 

by individuals who are addicted to low doses of 

opiates or individuals in the early stages of opiate 

addiction. The drug also can be abused in combination with methadone, making buprenorphine diversion more problematic in areas where heroin abuse 

and methadone therapy are common, such as the 

Northeast region. As buprenorphine therapy 

becomes more widespread, the potential for 

increased diversion of Subutex and Suboxone 

should be closely monitored.
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Sources

State

Maine

Washington County Sheriff’s Office

Pennsylvania

Department of Health

Federal

U.S. Department of Health and Human Services

Food and Drug Administration

National Institutes of Health

National Institute on Drug Abuse

Substance Abuse and Mental Health Services Administration
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Buprenorphine: Potential for Abuse

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