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As a medication that private physicians can prescribe under the Drug Addiction Treatment Act of 2000 (Public Law 106-310, referred to as "DATA 2000"), buprenorphine provides an alternative for patients who do not have access to methadone clinics or do not meet criteria for treatment in an opioid treatment program. For example, admission criteria for methadone treatment clinics often include opioid dependence for 1 year or more (Leshner, 2003). Patients are potential candidates for buprenorphine treatment through physicians’ offices if they meet the American Psychiatric Association’s current opioid dependence criteria (American Psychiatric Association, 2000). However, if buprenorphine treatment is given in an opioid treatment program, such as a methadone clinic, patients must meet the same Federal guideline criteria for admission that apply to methadone therapy(U.S. Department of Health and Human Services, 2001).
Under DATA 2000, physicians can apply to the Center for Substance Abuse Treatment, a component of the Substance Abuse and Mental Health Services Administration (SAMHSA), for a waiver of the Controlled Substance Act that will enable them to treat up to 10o patients (O’Connor, 2000).
Physicians may be eligible for the waiver if they meet at least one of the following criteria (SAMHSA, 2003):
1. Certification in addiction medicine through the American Board of Medical Specialties, American Society of Addiction Medicine, or American Osteopathic Association;
2. Completion of at least 8 hours of approved training in the treatment or management of patients dependent on opioids;
3. Other training or experience that demonstrates their ability to treat and manage opioid-dependent patients.
Physicians also must certify that they can provide or refer patients to needed ancillary services, such as behavioral counseling, mental health care, and case management (Clark, 2001).
The objectives of buprenorphine therapy are identical to those of treatment with methadone (Fudala and Johnson, 1995):
- To prevent opioid withdrawal signs and symptoms,
- To provide a comfortable induction onto the medication, and
- To then attenuate the motivations (such as craving) to use illicit opioids.
By eliminating illicit drug use, patients dependent on opioids can begin to focus on repairing family and social relationships, finding positive social support networks, obtaining fulfilling employment, and engaging in new forms of recreation and other activities that contribute to healthy, balanced living.
Buprenorphine, while effective for eliminating illicit opioid use, is not a cure for opioid dependence: No medication has been found to change the behaviors associated with illicit drug use. Like all other medications for drug dependence, buprenorphine will more successfully promote and sustain abstinence when prescribed as one component of a complete treatment regimen that also includes behavioral interventions (Montoya et al., 2003; National Consensus Development Panel on Effective Medical Treatment of Opiate Addiction, 1998).
On a societal level, treatment that includes buprenorphine has been shown to reduce the harmful effects of opioid dependence by reducing drug use severity, increasing social status, and impeding the spread of HIV/AIDS and other infectious diseases (Fhima et al., 2001; Kakko et al., 2003; Mattick et al., 2003). It may also provide a net economic advantage, with increased costs for the medication and for physician and nursing services offset by reductions in dispensing, counseling, and administrative costs as well as some of the costs patients must incur to obtain treatment (Rosenheck and Kosten, 2001). (See “Costs of Buprenorphine and Access to Care.”)
To date, few studies have examined which type of patient is best treated with buprenorphine rather than methadone. One study comparing buprenorphine and methadone-maintained patients observed that, unique to buprenorphine patients, those with histories of sedative dependence stayed in treatment longer and used less cocaine (Schottenfeld, Pakes, and Kosten, 1998). Other research has reported differential responses to buprenorphine between men and women, with women showing greater (Johnson et al.,1995a) or lesser drug use (Schottenfeld, Pakes, and Kosten, 1998) than did men or methadone-maintained women (Jones et al., 2001).
The clinician should consider a number of factors prior to starting a patient on buprenorphine.
First: The patient may be taking other medications that might make buprenorphine a more, or less, attractive option. Buprenorphine’s interactions with other medications tend to be similar to methadone’s but with some notable differences (see “Alcohol and Medication Interactions With Buprenorphine and Methadone”). In general, buprenorphine appears to have few significant drug interactions. When interactions occur, they appear to increase the effects of buprenorphine by decreasing its metabolism. Such interactions can easily be mitigated by a reduced buprenorphine dose.
Second: Some co-occurring medical conditions can be contra-indications for buprenorphine use. These could include difficult breathing or lung problems, kidney or gallbladder problems, head injury, severe mental disorders, adrenal or thyroid dysfunction, urination problems, or enlarged prostate. Patients taking buprenorphine who have hepatitis or impaired liver function should be routinely monitored, especially when taking high doses, because the medication’s potential to increase liver damage has not been fully evaluated (Petry et al., 2000).
The FDA has not approved methadone or buprenorphine for use during pregnancy. Buprenorphine is in FDA’s category C, a mid-level risk category within the range A (low risk)-C-D-X. Methadone is in category B. Category C drugs have shown adverse effects on fetuses in animal studies and have not been adequately studied in humans. Thousands of women have continued methadone maintenance throughout pregnancy with no apparent significant adverse fetal effects (Kaltenbach, Berghella, and Finnegan, 1998; Kandall et al., 1999; Wang, 1999).
FDA acknowledges that the potential benefits of methadone during pregnancy may outweigh possible hazards, and both SAMHSA and NIDA endorse methadone treatment for opioid-dependent women, regardless of pregnancy. However, because experience with buprenorphine is more limited and further studies are pending, current guidelines exclude the use of buprenorphine during pregnancy. They also recommend that women who become pregnant while receiving maintenance therapy with buprenorphine switch to methadone.
Women initiating opioid agonist treatment therefore require appropriate information to help them make informed decisions about each medication’s risks and benefits in case of pregnancy, including what they might experience should they become pregnant and change medications during pregnancy. (See Johnson, Jones, and Fischer, 2003, for a review of buprenorphine and pregnancy.)
Currently, buprenorphine is recommended for use only by patients aged 16 and older because safety and effectiveness data for younger adolescents are lacking. However, the use of heroin by American adolescents is at its highest level since the 1960s (U.S. Department of Justice, 1999), and results of an ongoing study at five sites in NIDA’s National Drug Abuse Treatment Clinical Trials Network (CTN) may prove illuminating.
The CTN study is comparing the effectiveness, for 14- to 21-year-olds, of Suboxone solely for detoxification (7 to 14 days) versus Suboxone detoxification plus maintenance therapy (3 months), when each is supplemented by twice-weekly psychosocial support for 3 months (Woody, 2003).
This study may confirm the reported finding of Marsch and colleagues (2003) that in a 28-day outpatient setting under double-blind conditions, buprenorphine was superior to clonidine—an antihypertensive medication often used to alleviate opioid withdrawal symptoms—in retaining patients in treatment and reducing their opioid use.
Exploring patients’ expectations for buprenorphine treatment is important. New medications often generate unrealistic hopes. Explaining to the patient what buprenorphine can do (block illicit opioid effects, decrease craving) and what it cannot do (prevent him or her from ever using drugs again) may help enhance treatment outcomes. Conversely, some patients may expect buprenorphine treatment to fail. Unless addressed, such an expectation can become self-fulfilling.
The decision to use buprenorphine is not irreversible. Should a patient have intolerable side effects or fail to respond to buprenorphine—that is, continue illicit opioid use after dose adjustments and stabilization on a maintenance dose—he or she can easily be switched to methadone.
References: 1. Science Practice Perspectives Volume 2, Number 2
August 2004 (Practical Considerations For The use of Buprenorphine) Hendree E. Jones Ph.D
If you are interested in acquiring more information on the use of buprenorphine in pregnancy, please request it and I will send you some updated information. You can request it at:
Deborah Shrira, Editor/Publisher/Webmistress May 2009