Opioid dependence in the United States is increasing in numbers with those addicted to heroin and prescription opioid analgesics. Opioid use includes morphine, codine, oxycodine, the painkillers oxycodone, hydrocodone, fentanyl, and heroin. Several different treatment options are available for opioid dependence. Behavioral therapy includes counseling, cognitive therapy, phychotherapy, and the twelve step recovery program developed by Alcoholics Anonymous. Prescriptions can also be used for the treatment of opioid dependence.
For example, methodone is used to help treat heroin abusers, and buprenorphine is used to treat opioid dependence, more specifically, Suboxone. What is Suboxone? Suboxone is manufactured by Reckitt Benckiser Healthcare and is distributed by Reckitt Benckiser Pharmaceuticals Inc. Suboxone is used to treat opioid dependence. According to the FDA, Suboxone is a combination of buprenorphine and naloxone in a single tablet. Buprenorphine is an opioid medication that produces less euphoric effects and because of this may be easier to stop taking.
Naloxone works by blocking the effects of opioids and should be administered under the tongue as directed so it will not affect the actions of buprenorphine. Suboxone is in the FDA pregnancy category C which means that it is not know if it will be harmful to an unborn baby. In October 2002, the U. S. Food and Drug Administration approved Suboxone for the treatment of opioid dependence. Suboxone is listed as a Schedule III controlled drug with the U. S. Drug Enforcement Administration.
Physicians may prescribe a month supply and five one-month renewals without any additional face-to-face visits, urine tests or other screenings (Reckitt Benckiser, 2007). Suboxone can cause drug dependence so if the client stops using the medication too quickly it can cause withdrawal symptoms. It is possible that withdrawal symptoms may also occur when starting the medication due to the dependence on another drug. When stopping the use of Suboxone the doctor may gradually reduce the dose to avoid or to minimize the withdrawal symptoms (Reckitt Benckiser, 2007).
Suboxone is available in 2mg/0. 5mg (buprenorphine/naloxone) and 8mg/2mg tablets that are an orange hexagonal shape. The daily targeted dose is twelve to sixteen milligrams and cost approximately nine dollars for sixteen milligrams (Reckitt Benckiser, 2007). The Suboxone tablet should be placed under the tongue and allowed to dissolve completely which will take five to ten minutes. Suboxone should not be chewed or swallowed as the tablets may cause withdrawal symptoms.
If taking the Suboxone sublingual film, it should be placed under the tongue and allowed to dissolve completely. If an additional film is prescribed per dose, the film should be place under the tongue on the opposite side from the first film. One placed under the tongue it should not be moved (Reckitt Benckiser, 2007). While taking Suboxone it can cause constipation so it is important to drink plenty of water. When treatment is completed, it is recommended that any unused tablets or film be flushed down the toilet.
This helps to prevent the abuse of Suboxone by opioid dependents as well as theft of the products to be sold on the streets. Side Effects and Overdose Serious side effects or overdose require medical attention. These include difficulty or slowed breathing, closing of the throat, swelling of the lips, tongue, or face, hive, yellowing of the eyes or skin, dark colored urine, light colored stools, decreased appetite for several days or longer, nausea, or lower stomach pain.
Symptoms of overdose may include seizures, dizziness, weakness, loss of consciousness, coma, confusion, tiredness, cold and clammy skin, and small pupils (Meir and Patkar, 2007). Less serious side effects of taking Suboxone are more likely to occur. If this occurs, continue to take the medication and contact the prescribing doctor. These include headache, pain, problems sleeping, nausea, sweating, stomach pain, or constipation. Since constipation is a side effect an increase in fiber intake and drinking plenty of water daily are recommended to lessen these effects (Meier and Patkar, 2007).
Other drugs can affect Suboxone and since Suboxone can cause death from overdose certain medications increase this risk. These are any benzodiazepines such as alprazolam, diazepam, or clonazepam; erythromycin or clarithromycin; itraconazole or ketoconazole; an HIV protease inhibitor such as indinasvir, ritonavir, or saquinavir; rifampin, rifapentine or rifabutin; phenytoin; carbamazepine; or barbiturates such as Phenobarbital, mephobarbital, or others (Reckitt Benckiser, 2007). Clinical Trials for Suboxone Treatment
In the first clinical trial that was published in the Journal of the American Medical Association, used for an extended period of time to treat opioid addiction in young adults received counseling and Suboxone for twelve weeks found that they had substantially better outcomes than those who received the standard treatment of short-term detoxification and counseling. Those that took Suboxone for twelve weeks were less likely to use opioids, cocaine and marijuana, to inject drugs, or to drop out of treatment than those who received the short-term detoxification and counseling.
The study was conducted on one hundred fifty-four opioid-addicted patients age fifteen to twenty-one that had been addicted to opioids for an average of one and a half years at six outpatient treatment clinics around the country. All participants received group and individual counseling for twelve weeks. The participants were randomly assigned to either two weeks of detoxification using Suboxone or twelve weeks of extended Suboxone treatment where the daily dose was gradually decreased starting at week nine and discontinued at week twelve.
Follow-up evaluations conducted at six, nine, and twelve months showed increased rated of opioid use in both groups compared to the end of the treatment period; however, rates of opioid use were lower in the extended treatment group (Leonard, 2009). George E. Woody, M. D. of the Treatment Research Institute at the University of Pennsylvania who conducted the study with his colleagues stated, “It’s hard to say what the ideal length of time for treatment is. When you start treatment, there are psychological features of addiction. First, you want to make sure they are not taking anything other than the methadone or the Suboxone.
Then they need to be in a stable psychosocial situation. You want them to feel ready for it. And then, and only then, do you do the taper. But you still have to follow them, and not be hesitant to restart them. Because if they don’t do well, they can overdose and die” (Drug and Alcohol Weekly, 2008). Abuse of Buprenorphine in the U. S. Study With the increase of medical availability of buprenorphine there have been concerns about the abuse potential. There have been international cases of misuse and abuse-related morbidity and mortality.
In Finland, intravenous abuse of these drugs has been reported among intravenous users (Smith, Bailey, Woody, and Kleber, 2007). Little is known amount the abuse in the U. S. so to address this issue Smith, et al. , 2007 assessed trends using data from the regional toxic surveillance systems. Study data consisted of calls received from 2003 to 2008 covering twenty different states. Call criteria specified that (a) the exposure resulted from incorrect use of a substance to get a high and (b) the substance involved was Subutex or Suboxone.
Of the two combined drugs seventy-seven cases were reported. Of these, 92. 2 percent involved Suboxone with the mean number of abuse cases per quarter of 7. 88 (standard deviation of + 5. 68). During the study there were 474,860 prescriptions filled with eighty-four percent being for Suboxone. The finding that Suboxone had a slightly higher abuse ratio than Subutex could be because Subutex is used only during induction while Suboxone is recommended for use in all three phases of treatment including long-term maintenance.
While the results show abuse, the level of abuse is low relative to the number of prescriptions that were dispended (Smith et al. , 2007). Ethnographic study. Monte, Mandell, Wilford, Tennyson, and Boyer (2009) conducted a cross-sectional study in Worchester, Massachusetts and Montpelier, Vermont from October 1, 2007 to March 31, 2008. Participants participated in an open-ended interview-administered survey. The twenty-nine item survey included participant demographics, substance abuse history, drug treatment history, and knowledge, attitudes, beliefs, and practices related to Suboxone.
To increase internal validity results, the participants were asked to identify buprenorphine and naloxone tablets. During the assessment, Monte et al. , (2009) used a forty-nine item form to collect information using agree/disagree answers. Of the fifty-one participants in the study, forty-nine of them were aware of Suboxone as a medication and all of them had used it for one of the following reasons: to avoid opioid withdrawal, because the individual lacked sufficient funds to purchase the preferred opioids of abuse, or because trusted sources of opioids were unavailable.
It was also found that thirty of the participants obtained the drug from an individual with a legitimate prescription and the other nineteen participants purchased it from heroin dealers. They reported that it is common for those participants in Suboxone treatment to inflate the severity of the withdrawal symptoms. This leads the prescribing doctor to over-prescribe the drug and then they sell the unneeded Suboxone. Monte et al. (2009) recommended to clinicians that oversee Suboxone induction apply greater scrutiny to anyone who reports unexpected intensity of opioid abstinence symptoms while initiating treatment. They also recommend more frequent follow-up office visits, employing drug testing capable of detecting buprenorphine, and utilizing random patient call-ins for drug testing and pill counting, improved case management to ensure patients receive psychosocial services that enhance the success. Unsupervised administration of suboxone study.
Unsupervised administration simply means that the daily administration of the medication is not supervised. According to Bell, Byron, Gibson, and Morris (2004) three issues arise with unsupervised administrations which are: (1) is the combination product acceptable; (2) for who should it be available; and (3) how should it be monitored? In this study Bell et al. , (2004) required participants to go through two months of observation and submit to urine testing twice a week and provide documentation of at lease twenty hours per week of employment.
After the participants meet the requirements they were switched to Suboxone and monitored daily for three to seven days to monitor withdrawal symptoms and adjust dosing if needed after which they were supplied a week’s supply of medication. Monitoring was then conducted weekly for three months and they were called randomly to submit to urine testing. Research interviews were conducted at three and six months and stable subjects were allowed to continue in the open-label treatment, picking up Suboxone every two to four weeks.
During this time they were also invited to talk about their experiences in one hour semi-structured in-depth interviews. Among those submitting to urine samples, persisting use of heroin was common with fifty-two percent of the samples testing positive for morphine. The findings of this study suggest that Suboxone can be given without supervised administration. The combination product was well tolerated and fifteen of the seventeen participants remained in treatment after six months and most remained in treatment after eighteen months after the trial ended.
The intensity of monitoring of patients appears to be critical to the treatment outcomes (Bell et al. , 2004). Cost effectiveness study. Bell et al. , (2007) studied the effectiveness and cost-effectiveness of observed versus unobserved administration of buprenorphine-naloxone for heroin dependence. Of the one hundred nineteen participants in this study treatment, all received Suboxone treatment for thirteen weeks.
Over the first four days a treatment plan was developed consisting of detoxification or maintenance. If maintenance was of interest the participant was informed of the study and invited to participate. Participants were assigned to observed or unobserved dosing, with medication dispensed weekly that was taken at home. The results of this study found that the mean dose for the duration of treatment for the observed group was eleven milligrams and for the unobserved group it was twelve milligrams.
It was found that retention did not differ significantly in the groups with fifty-seven percent in the unobserved group and sixty-one percent with the observed group. The mean cost of the intervention treatment for the unobserved group was $1636 and the observed group was $2103. So close clinical monitoring, but no observed dosing, was significantly cheaper and therefore significantly more cost-effective (Bell et al. , 2007). Office-Based Treatment The numbers of potential patients far outnumber the treatment positions available.
It is estimated that at least 800,000 treatment spaces are needed for opioid dependence. Physicians that wish to prescribe buprenorphine must meet the qualifications outlined in DATA 2000, have a state medical license and Drug Enforcement Administration (DEA) registration to dispense controlled substances, meet the criteria based on physician training, to complete an eight-hour training course, agree to not treat more than thirty patients with buprenorphine, certify they have the capacity to refer patients for ancillary services.
In addition they must also complete and submit a waiver notification through the Center for Substance Abuse Treatment/Substance Abuse and Mental Health Services Administration (CSAT/SAMHSA). Once CSAT determines if the doctor is a qualified provider, the DEA will determine if the applicant has a registration for prescribing controlled substances. A new DEA number will be assigned for writing prescriptions for buprenorphine with formal notification in writing (McCance-Kratz, 2004). Buprenorphine Maintenance
Buprenorphine can be used in long-term, maintenance treatment, or it can be used as an agent in therapeutic medical withdrawal from opioids based on their clinical needs. Once the patient is stabilized in treatment, office visits can decrease to once every two weeks to once a month but it is recommended that they be seen at least once a month. The decision to end treatment should be a joint one made with the patient and the therapists and physicians, providing additional treatment to the patient as necessary (McCance-Kratz, 2004).
Medication therapy alone will not effectively treat opioid dependence. The patient needs to gain an understanding of the impact of substance abuse on their lives and the lives of those around them, obtain an understanding of the triggers for their abuse of substances, learn coping skills to avoid relapse to substance use, and their comorbid medical and psychiatric disorders be diagnosed and treated. It is imperative that the prescribing doctor have a variety of community providers who can meet the patients’ identified needs (McCance-Kratz, 2004).
Summary In summary, Suboxone has been proven to be an effective treatment for opioid dependence. It is recommended that Suboxone not be taken alone and that the patient receives the appropriate services needed to not relapse. While most studies showed that it is not only an effective treatment, it was also found that unobserved administration was more cost effective than the observed administration.
In order for the patient to be successful in his or her recovery they must gain an understanding of the impact of substance abuse on their lives and the lives of those around them, obtain an understanding of the triggers for their abuse of substances, learn coping skills to avoid relapse to substance use, and their comorbid medical and psychiatric disorders be diagnosed and treated.
Alcoholism and Drug Abuse Weekly (2002). FDA approved two formulations of buprenorphine; Suboxone preferred. December 23, 2002 7-8 Alcoholism and Drug Abuse Weekly (2010). Off-label use of buprenorphine for pain worries officials. January 11, 2010, 22, 1-3 ISSN: 1042-1394 Bell, James, Byron, Gaye, Gibson, Amy and Morris, Amanda (2004). A pilot study of buprenorphine-naloxone combination tablet (Suboxone) in treatment of opioid dependence. Drug and Alcohol Review, 23, 311-317 doi: 10. 080/09595230412331289473 Bell, James, Shanahan, Marian, Mutch, Carolyn, Rea, Felicity, Ryan, Anni, Batey, Robert, Dunlop, Adrian and Winstock, Adam (2007). A randomized trial of effectiveness and cost-effectiveness of observed versus unobserved administration of buprenorphine-naloxone for heroin dependence. Society for the Study of Addiction, 102, 1899-1907 doi: 10. 1111/j. 1360-0443. 2007. 01979. x McCance-Katz, Elinore F. , (2004). Office-Based Buprenorphine Treatment for Opioid- Dependent Patients.
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