Twelve-month maintenance treatment of opium-dependent patients. A controlled trial of buprenorphine treatment for opium dependence: the first experience from Iran. Sublingual buprenorphine for treatment of neonatal abstinence syndrome: a randomized trial. [Evaluation of 2 homeopathic products on the resumption of transit after digestive surgery. A multicenter controlled trial]. Pharmacological and behavioral treatments of cocaine dependence: controlled studies. Increased maintenance corticosteroids during upper respiratory infection decrease the risk of relapse in nephrotic syndrome. Therapy of the neonatal abstinence syndrome with tincture of opium or morphine drops. Clonidine as an adjunct therapy to opioids for neonatal abstinence syndrome: a randomized, controlled trial. [Oral bacterial therapy in prevention of antibiotic-induced diarrhea in childhood]. The value of maintenance theophylline in steroid-dependent asthma. Changes in HIV risk behaviors among patients receiving combined pharmacological and behavioral interventions for heroin and cocaine dependence.
The goal of this study was to compare the effects of 1, 3 and 8 mg per day doses of buprenorphine in the maintenance treatment of opium-dependent subjects in Iran over a treatment period of 12 months. Participants were randomized to three equal groups (171 subjects per group) of opium-dependent individuals who met the DSM-IV criteria for opioid dependence and were seeking treatment. They were treated in an urban outpatient clinic, offering a 1-hour weekly individual counseling session. Overall, 282 subjects (55%) completed the 12 months study. Completion rates by dosage group were 46 (26.9%) for the 1 mg dose group, 102 (59.6%) for the 3 mg dose group, and 134 (78.4%) for the 8 mg dose group (p =.000). These findings are consistent with previous reports of effective buprenorphine use in western countries as a suitable maintenance treatment for opium dependence. To evaluate the effect of a 4 mg/day sublingual dose of buprenorphine in the maintenance treatment of opium dependence in comparison with a 1 mg/day dose over an 18-week treatment period. As a secondary objective, the results were determined concurrently for subjects treated with a 2 mg/day dose.
                Subjects were assigned randomly to three dosage groups.
                330 consecutive (320 men and 10 women) opium addicts who met the DSM-IV criteria for opioid dependence and were seeking treatment.
                Subjects received a 1, 2 or 4 mg/day dose of buprenorphine and were treated in an outpatient clinic where they also received a weekly 1-hour clinical counseling session.
                Addiction Severity Index, retention in treatment, and illegal opioid use as determined by random urine testing.
                The mean age was 37.5 years (SD=11.4, range 19-72). Overall, 194 (58.8%) of the patients completed the 18 week study. Completion rates by dosage groups were 47.3% for the 1 mg group, 58.2% for the 2 mg group and 70.9% for the 4 mg group (chi(2)=12.7, df=2, P=0.0017).
                The results support the efficacy and safety of buprenorphine for opium addiction and suggest that an adequate dose of buprenorphine would help to increase the success rate. In utero exposure to drugs of abuse can lead to neonatal abstinence syndrome, a condition that is associated with prolonged hospitalization. Buprenorphine is a partial mu-opioid agonist used for treatment of adult detoxification and maintenance but has never been administered to neonates with opioid abstinence syndrome. The primary objective of this study was to demonstrate the feasibility and, to the extent possible in this size of study, the safety of sublingual buprenorphine in the treatment of neonatal abstinence syndrome. Secondary goals were to evaluate efficacy relative to standard therapy and to characterize buprenorphine pharmacokinetics when sublingually administered.
                We conducted a randomized, open-label, active-control study of sublingual buprenorphine for the treatment of opiate withdrawal. Thirteen term infants were allocated to receive sublingual buprenorphine 13.2 to 39.0 mug/kg per day administered in 3 divided doses and 13 to receive standard-of-care oral neonatal opium solution. Dose decisions were made by using a modified Finnegan scoring system.
                Sublingual buprenorphine was largely effective in controlling neonatal abstinence syndrome. Greater than 98% of plasma concentrations ranged from undetectable to approximately 0.60 ng/mL, which is less than needed to control abstinence symptoms in adults. The ratio of buprenorphine to norbuprenorphine was larger than that seen in adults, suggesting a relative impairment of N-dealkylation. Three infants who received buprenorphine and 1 infant who received standard of care reached protocol-specified maximum doses and required adjuvant therapy with phenobarbital. The mean length of treatment for those in the neonatal-opium-solution group was 32 compared with 22 days for the buprenorphine group. The mean length of stay for the neonatal-opium-solution group was 38 days compared with 27 days for those in the buprenorphine group. Treatment with buprenorphine was well tolerated.
                Buprenorphine administered via the sublingual route is feasible and apparently safe and may represent a novel treatment for neonatal abstinence syndrome. The effects of two homeopathic preparations, Opium and Raphanus, given in dilutions of 10(30) (15 HC) and 10(10) (5 HC) respectively, on the resumption of intestinal peristalsis after operations on the digestive tract were evaluated in a controlled, double-blind therapeutic trial involving patients from 12 hospitals. The patients were allocated at random into 4 groups of 150 each: 1 untreated group and 3 groups who received either Opium and Raphanus, or Opium and the placebo of Raphanus or the placebos of the two products. The results were assessed on the time elapsed between closure of the abdominal wall and the first faeces and (accessorily) the first bowel sounds and passing of flatus per rectum. Pre-operative and operative features were similar in all 4 groups. There was no significant difference in the effects of treatment between the groups, even when such predictive factors as type and duration of surgery and age were taken into account. It is concluded that the trial failed to demonstrate any effect of Opium or Raphanus on the resumption of intestinal peristalsis after digestive tract surgery. Nor did it confirm the activity of ultra-molecular dilutions claimed for this type of drugs. The cocaine epidemic has stimulated novel treatments aimed at reducing relapse to this extremely addicting drug. After detoxification and standard treatment, former cocaine users continue to exhibit strong cocaine craving and physiological changes when presented with cocaine-related stimuli. Because these conditioned responses may increase the risk of relapse, a new treatment has been developed to extinguish such responses. The extinction process, consisting of repeated presentations of cocaine-related stimuli until the stimuli gradually lose their ability to evoke conditioned responses, is integrated into a comprehensive rehabilitation program. Cocaine dependence is often combined with opiate dependence. Desipramine has been added to methadone maintenance in an attempt to reduce dependence on both substances. Methadone impedes catabolism of desipramine so that relatively low doses of desipramine may produce antidepressant effects and possibly reduce the desire to use cocaine. Preliminary evidence from a placebo-controlled study of desipramine in combination with methadone suggests that desipramine produces significant improvements in psychological functioning, but its effects on reduction of cocaine use are less dramatic. Relapses are common in children with idiopathic nephrotic syndrome, and this prospective study looks into the possibility of decreasing the frequency of relapses in a selected group of such patients. The study includes 36 children with a steroid-dependent, relapsing nephrotic syndrome on a maintenance prednisone therapy of about 0.5 mg/kg every other day. They were prospectively divided into two groups with comparable age and sex distribution and the number of those who had previously received cyclophosphamide therapy. Group 1 patients were advised to take daily prednisone for 5 days, starting at the time of the onset of an upper respiratory tract infection (URI). No such advice was given to those in group 2, and they remained on alternate-day prednisone during URI. At the end of a 2-year follow-up period, the total number of relapses in group 1 was 40 with a mean of 2.2 +/- 0.87 per patient as compared with 99 with a mean of 5.5 +/- 1.33 per patient in group 2 (p = 0.04). We conclude that an increased maintenance prednisone during URI helps decrease significantly the number of relapses in those on alternate-day therapy.
                Copyright 2000 S. Karger AG, Basel Treating opioid-addicted women with methadone in pregnancy increased the number of newborns suffering from neonatal abstinence syndrome (NAS). High-pitch crying, insomnia, tremor, myoclonic jerks, vomiting, diarrhoea and poor weight gain were reported symptoms, which were evaluated using the Finnegan (F)-score. Earlier phenobarbital or paregoric had been used to suppress symptoms. We surveyed the administration of pure mu-agonist morphine (MO) in comparison to the alcoholic opioid mixture in tincture of opium (TO). Thirty-three newborns were included in the survey, after informed consent by their parents.
                NAS started 3-5 days after delivery and lasted for 27 or 30 days (mean) in the TO and MO groups, respectively. In either of the tested parameters, we found no significant differences between the two groups (2P < 0.05). The maximum F-score was similar in both groups, but the dose to suppress NAS was higher in the MO group (0.6-0.5 mg/day; total dose 61.6-42.7 mg of morphine). The duration of the therapy was longer in the MO than in the TO group (37.5-32.4 days). On the other hand the weight gain was better in the MO group than in the TO group (25-19 g/day), but was reduced in both groups compared with healthy newborns.
                Morphine is suitable to treat NAS in a similar manner as tincture of opium, but avoids unwanted effects of the alcoholic extracts with various alkaloids in the tincture of opium and allows better weight gain of the newborns. To determine if oral clonidine would reduce the duration of opioid detoxification for neonatal abstinence syndrome.
                Infants with intrauterine exposure to methadone or heroin and neonatal abstinence syndrome (2 consecutive modified Finnegan scores of > or =9) were enrolled at 2 hospitals during 2002-2005 and followed until final hospital discharge. All enrolled infants (80) received oral diluted tincture of opium according to a standardized algorithm and were randomly assigned to receive oral clonidine (1 microg/kg every 4 hours) (40 infants) or placebo (40 infants). Primary outcome was duration of opioid therapy. Secondary outcomes included the amount of opium required to control symptoms, number of treatment failures, and differences in blood pressure, heart rate, and oxygen saturation.
                The median length of therapy was 27% shorter in the clonidine group (11 [95% confidence interval: 8-15 days]) than in the placebo group (15 days [95% confidence interval: 12-17 days]). In the clonidine group, 7 infants required restarting opium after initial discontinuation versus none in the placebo group, with the total length of treatment/observation remaining significantly less in the clonidine group. Higher dosages of opium were required by 40% of the infants in the placebo group versus 20% in the clonidine group. Treatment failures occurred in 12.5% of the infants in the placebo group versus none in the clonidine group. Hypertension, hypotension, bradycardia, or desaturations did not occur in either group. Three infants in the clonidine group died as a result of myocarditis, sudden infant death syndrome, and homicide, all after hospital discharge and before 6 months of age.
                In this randomized, double-blind trial, adding clonidine to standard opioid therapy for detoxification from in utero exposure to methadone or heroin reduced the duration of pharmacotherapy for neonatal abstinence without causing short-term adverse cardiovascular outcomes. A larger trial is indicated to determine long-term safety. Amoxycillin is currently the most widely used antibiotic in pediatrics. It is known that this antibiotic, as well as other kinds of antimicrobial treatments, may produce variations in the bowel ecosystem. A controlled randomised clinical trial was performed using commercially available fermented milk products in infants who had received an oral treatment with amoxycillin for an average of ten days. 40 children have been examined, randomly divided into two groups of twenty. Group 1 received treatment with antibiotic plus lactobacilli. Group 2 received only amoxycillin. At the end of the trial infants of group 1 showed a lower frequency of stool passages and more fully-formed feces, while patients of group 2 presented an increased frequency of gastrointestinal disorders. On the basis of the results obtained it is possible to conclude that oral bacterial therapy with lactobacilli is efficacious in preventing diarrhea from amoxycillin in infancy. We examined the value of maintenance theophylline at serum concentrations of 10 to 20 micrograms per milliliter in a placebo-controlled, randomized, double-blind trial of 33 children with steroid-dependent chronic asthma. Patients were free of all symptoms 63 +/- 6 per cent of the days (mean +/- S.E.M.) when taking theophylline as compared with 42 +/- 6 per cent when taking placebo (P < 0.01). Inhaled metaproterenol was required twice as often with placebo (P < 0.01), and additional daily corticosteroids were needed more than three times as often with placebo (P = 0.02). Daily peak flow measurements improved with theophylline (P < 0.01) as did monthly spirometric measurements and residual volume measured by plethysmography. Theophylline was associated with a 50 per cent increase in the number of patients able to complete an exercise test (P = 0.01) and with a smaller decrease in forced expiratory volume in one second among patients completing the exercise (P < 0.02). We conclude that maintenance bronchodilator therapy with theophylline can provide clinically important benefit for patients with chronic steroid-dependent asthma. Cocaine use is associated with injecting and sexual HIV risk behaviors. This study was a randomized controlled trial of behavioral interventions for cocaine dependence and HIV risk behaviors among dually (cocaine and heroin) dependent outpatients. Methadone maintenance was augmented with cognitive-behavioral therapy (CBT), contingency management (CM), both (CBT+CM), or neither. The study sample (n=81) was 52% female, 70% African American, and 37.9+/-7.0 years old. Proportions reporting HIV risk behaviors at intake were: 96.3% (78/81) injection drug use, 56.8% (46/81) sharing needles, 30.9% (25/81) unprotected sex, 28.4% (23/81) trading sex for money or drugs. Proportions who no longer reported behaviors at study exit were: 51.3% (40/78) injection drug use, 91.3% (42/46) sharing needles, 88% (22/25) unprotected sex, 91.3% (21/23) trading sex for money or drugs. Participants receiving CBT+CM were more likely to report cessation of unprotected sex relative to control (OR=5.44, 95% CI 1.14-26.0, p=0.034) but this effect was no longer significant after adjusting for drug-negative urines. These results suggest broad beneficial effects of methadone maintenance augmented with behavioral interventions for reducing HIV risk behaviors.
It is not possible to conclude about the use of any kind of pharmacologic therapies for maintenance treatment of opium dependence.