Patients admitted to acute urban psychiatric facilities often have substance related disorders that can complicate their diagnosis and treatment. Those with heroin dependence require a safe and effective method for providing short-term detoxification. While methadone and clonidine have been available for this purpose for many years, they have important disadvantages. Given its pharmacological characteristics, buprenorphine may be a good alternative. Our open-label study suggests that the injectable buprenorphine formulation used sublingually may be beneficial for medically supervised opiate detoxification of heroin-dependent subjects during an inpatient psychiatric hospitalization. This conclusion is based on the high retention in treatment, decrease in withdrawal scores, lack of reported adverse events, and high degree of patient satisfaction.
Humanely managing opioid withdrawal on an inpatient psychiatric unit is necessary to provide optimal care and to retain patients in the hospital long enough to correctly diagnose and treat them. Previous buprenorphine detoxification studies have primarily been efficacy trials conducted in substance abuse research units. Controlled conditions allow for more reliable conclusions. However, the rigorous standards employed in these trials are often not possible in a real-world setting. This study is the first trial that assesses buprenorphine's utility in detoxifying patients hospitalized in a psychiatric facility.
The off label use of medications is common practice in medicine, particularly in psychiatry. Opioid withdrawal has been treated off label for many years with clonidine. Buprenorphine is FDA-approved for the management of pain. Although it is anticipated that it will be accepted by the FDA for the treatment of heroin withdrawal/dependence, it currently can only be administered for research purposes under an Investigational New Drug Application (IND). However, the Narcotic Addict Treatment Act of 1974 (Title 21 Section 1306.07 (b)) allows a licensed physician to use any FDA-approved narcotic medication for 3 days to relieve the acute withdrawal symptoms of heroin-addicted patients without an IND or registration as a narcotic treatment program. Such emergency treatment is frequently referred to as the 3-day rule. Furthermore, 1306.07 (c) states that this section is not intended to impose any limitations on a physician or authorized staff to administer or dispense narcotic drugs in a hospital to maintain or detoxify a person as an incidental adjunct to medical or surgical treatment of conditions other than addiction. Our subjects were admitted to the psychiatric hospital for treatment of psychiatric illness. As it turns out, many had mood disorders that were likely related to their addiction. However, they were not admitted for the treatment of their addiction, per se, making short term detoxification with buprenorphine possible under the 3-day rule.
The study was viewed as a success by patients and staff, leading the hospital administration to redesign the detoxification protocols with the intent of potentially eliminating clonidine and adding buprenorphine. All subjects in this study were able to complete the buprenorphine detoxification successfully without side effects requiring cessation of the protocol. None of the buprenorphine detoxified patients asked to be discharged due to detoxification dissatisfaction. Nursing staff also supported the use of this protocol because they felt patients were less agitated and irritable, which helped reduce one-on-one monitoring, use of restraints, patient fights, staff time, and potential staff/patient injuries. A review of historical data from the patients admitted to this trial revealed that those who had been previously detoxified at our facility (primarily with clonidine) more frequently requested early discharges (56% vs. 15%) and concomitant medications (24 units vs. 13 units), supporting the hypothesis that buprenorphine was beneficial and well-tolerated. Future research will focus on collecting objective data to support these observations.
Study limitations include a small sample size and open label design without a control group. A little less than half the patients were treated with psychotropic medications. However, it is unlikely that this therapy contributed greatly to the resolution of psychiatric symptoms, other than insomnia, due to the short treatment duration. This study was not conducted on a research unit. Consequently, while nursing staff were trained to complete the CINA scale, there may not have been consistent interrater reliability. However, these authors believe that this treatment environment probably more closely mimics other urban inpatient facilities than a research setting might. Finally, although illicit drug use was not objectively monitored, patients were evaluated for subjective symptoms of intoxication by nursing staff and remained on a locked psychiatric unit throughout the detoxification. Many of these limitations are consistent with what would be expected in nonresearch setting (Wells, 1999
). A larger study may further substantiate the findings.
In conclusion, this trial suggests that injectable buprenorphine administered sublingually for 3 days appeared to be beneficial in preventing heroin withdrawal symptoms, well-tolerated, and accepted by a psychiatric inpatient population at an inner city hospital. Future research should compare this agent to standard treatments such as clonidine and methadone in a similar setting and investigate the transition to long-term substance abuse and psychiatric treatment.