Buprenorphine maintenance treatment (BMT) is used to treat individuals with opioid dependence. As with methadone maintenance treatment, the goals of BMT are to alleviate withdrawal symptoms, suppress opiate effects and cravings, and decrease the risk of overdose as a result of the illicit use of opioids.
Opioids such as heroin or morphine cause a release of excess dopamine in the body. Users become dependent on the drug because they need opiates to continuously occupy the opioid receptor in the brain. Similar to methadone, buprenorphine works by occupying this receptor and blocking the high that usually comes from illicit opioid drug use.
Buprenorphine exerts a weaker agonist effect at opioid receptor sites because it is a partial agonist. The effects of buprenorphine increase as the dosage of the drug are increased, until at moderate doses the effects reach a plateau and no longer continue to grow (known as the ceiling effect). The maximal effects of buprenorphine are usually reached in the 16–32 milligram (mg) dose range. Methadone causes a stronger agonist effect because it is a full agonist. However, there is no ceiling to the level of effects that methadone can induce, which can lead to fatal overdoses if the drug is used illicitly. Thus, buprenorphine can be used as a viable pharmacological alternative to methadone because it carries a lower risk of abuse, overdose, and side effects than do full opioid agonists.
Another benefit is the dosing schedule. Although the effects of buprenorphine are not as strong as methadone, they last longer. While methadone requires daily dosing, buprenorphine can be taken once every 2 days. This can be an advantage in BMT because opioid-addicted patients may be turned off to treatment that requires daily dosage and visits to the clinics, whereas buprenorphine offers the option of alternate day dosing.
In addition, buprenorphine can be dispensed in office-based settings. Although methadone can only be dispensed from federally licensed opioid treatment programs, buprenorphine can be administered by physicians in their offices.
There are generally three stages of BMT: induction, stabilization, and maintenance. During the induction phase, patients are medically monitored during the beginning of the buprenorphine therapy. The stabilization phase begins once patients have greatly reduced or stopped their opioid abuse. At this phase they no longer have cravings and experience few or no side effects. The dosage may be adjusted during this phase. Finally, the maintenance phase is reached once patients are on a steady dose of buprenorphine. The length of time patients continue to receive BMT varies by individual and may be indefinite.
On top of administering medication, BMT can provide patients with comprehensive rehabilitation services. Services can include group therapy, individual therapy, medical services, and referrals to community-based agencies.
Buprenorphine can also be prescribed in combination with naloxone, a drug that is used to counter the effect of opiate overdose. Naloxone is added to buprenorphine to reduce the likelihood of diversion and abuse of the medication.
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Days of Participation
The results from the randomized trial conducted by Krook and colleagues (2002) found that the buprenorphine group had significantly more days of participation compared with the placebo group. The buprenorphine group had an average of 42 days of participation, while the placebo group had an average of 14 days of participation. Log-rank tests of equality of survival distributions also showed the two groups were significantly different.
After 12 weeks of treatment, only 16 patients in the buprenorphine group and 1 patient in the placebo group completed the program. The most common reason for dropping out before the 12 weeks was patients missing 4 consecutive days of treatment (which meant that further medication was withdrawn and they were considered noncompleters).
The self-reported use of heroin or other drugs decreased significantly in the buprenorphine group compared with the placebo group. The 16 patients who completed the 12 weeks of buprenorphine treatment had a larger decrease in reported heroin use and use of other drugs compared with the patients in the buprenorphine group who did not complete treatment.
Well-being and Mental Health
The buprenorphine group showed a significantly larger increase in self-reported well-being compared with the placebo group. There were no significant differences between the two groups in reporting of anxiety and depression. The buprenorphine treatment completers reported a larger increase in well-being and life satisfaction and a larger decrease in anxiety and depression compared with treatment noncompleters.
Some self-reported positive effects of treatment were reported significantly more often in the buprenorphine group, including fewer cravings, having a more normal life, and feeling more content to live.
Opiate and Other Drug Use
Fudala and colleagues (2003) found that during the double-blind trial both of the buprenorphine-based treatments significantly reduced opiate use. The percentage of urine tests that were opiate negative was 17.8 percent in the buprenorphine and naloxone combination treatment group and 20.7 percent in the buprenorphine-only group, compared with 5.8 percent in the placebo group.
The drug (other than opiates) most commonly detected in the urine tests was cocaine. The frequency of cocaine-positive samples did not differ significantly between the three groups. There was also no difference in the frequency of samples that tested positive for benzodiazepines, amphetamines, barbiturates, and methadone, but those drugs were detected in fewer than 5 percent of the samples.
During the open-label study in which all participants received the combination of buprenorphine with naloxone, the percentage of opiate-negative urine samples ranged from 35.2 percent to 67.4 percent throughout the 48-week study. The overall rate of opiate use was lower than the double-blind trial, whereas the use of cocaine and benzodiazepines remained relatively constant.
The buprenorphine-based treatments also significantly reduced cravings for opiates. The mean craving scores in the combination treatment group and buprenorphine-only group were significantly lower than in the placebo group.
Health and Well-being
In addition, the overall self-reported health and well-being of participants in the combined-treatment and buprenorphine-only groups improved to a significantly greater extent than it did in the placebo group. In all groups, participants’ self-reports of their overall status relative to the previous assessments showed improvements, but the improvements were not statistically significant.
The overall rate of adverse effects did not differ significantly among the three groups in the double-blind trial. Seventy-eight percent of the combination treatment group, 85 percent of the buprenorphine-only group, and 80 percent of the placebo group reported adverse effects such as headache, withdrawal syndrome, pain, or insomnia. Only 20 percent of the participants reported adverse events in the open-label study.
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