A Controlled Trial of Dothiepin and Placebo in Treating Benzodiazepine Withdrawal Symptoms

1996 ◽  
Vol 168 (4) ◽  
pp. 457-461 ◽  
Author(s):  
Peter Tyrer ◽  
Brian Ferguson ◽  
Cosmo Hallström ◽  
Marian Michie ◽  
Stephen Tyrer ◽  
...  
Keyword(s):  
Tricyclic Antidepressants ◽  
Drug Withdrawal ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Withdrawal Symptoms ◽  
Antidepressant Effect ◽  
Double Blind ◽  
Benzodiazepine Dependence ◽  
Benzodiazepine Withdrawal ◽  
To Receive

BackgroundThe possibility that treatment with tricyclic antidepressants, in the form of dothiepin, might attenuate benzodiazepine withdrawal symptoms was investigated in a double-blind trial.MethodEighty-seven non-depressed psychiatric out-patients with putative normal dose benzodiazepine dependence had their benzodiazepines reduced in stepwise amounts of 20% of the original dose for eight weeks. The patients were randomised to receive dothiepin (with dosage increasing to 150 mg/day) or placebo as an aid to withdrawal before benzodiazepine reduction and these drugs were taken for four further weeks before being stopped.ResultsFewer patients entered and completed the study than expected and a Type II error was possible in the results. Although there was some evidence of withdrawal symptoms being less marked in those patients allocated to dothiepin this was independent of any antidepressant effect as depression scores were lower in the placebo group in the early phase of withdrawal (P<0.01). Of those completing the study, greater satisfaction (P=0.03) was recorded by those who had received dothiepin; no other differences reached statistical significance.ConclusionsDothiepin (and by implication other tricyclic antidepressants) might have some value in reducing benzodiazepine withdrawal symptoms but does not aid drug withdrawal.

scholarly journals The Effects of Quetiapine on Craving and Withdrawal Symptoms in Methamphetamine Abuse: A Randomized, Double-Blind, Placebo-Controlled Trial

2020 ◽  
Vol 10 (4) ◽  
pp. 29374.1-29374.7
Author(s):  
Najme Sadat Javdan ◽  
◽  
Amir Ghaderi ◽  
Hamid Reza Banafshe ◽  
◽  
...  
Keyword(s):  
Controlled Trial ◽  
Withdrawal Symptoms ◽  
Chi Square ◽  
Double Blind ◽  
Methamphetamine Abuse ◽  
Beneficial Effects ◽  
Amphetamine Withdrawal ◽  
Significant Difference ◽  
Chi Square Test ◽  
To Receive

Background: Patients with Methamphetamine Abuse (MA) are susceptible to many complications like craving, and withdrawal symptoms. These trials were designed to evaluate the effect of quetiapine administration on craving and withdrawal symptoms in MA abuse. Methods: This trial was conducted on 60 people with MA abuse to receive either 100 mg quetiapine (n=30), or placebo (n=30) every day for 2 months. The Desire for Drug Questionnaire (DDQ) and Amphetamine Withdrawal Questionnaire (AWQ) scores were evaluated at baseline and after 2 months’ intervention. For data analysis, t test, and the Chi-square test were applied in SPSS v. 18. Results: Quetiapine significantly decreased DDQ (P=0.002) and AWQ symptoms (P=0.001) compared to the placebo. Furthermore, there was a significant difference among groups in terms of the frequency of negative urine tests (P<0.001). Conclusion: This trial showed that administration of quetiapine supplements for 2 months in individuals with MA abuse had beneficial effects on craving and withdrawal syndrome.

348 Absence of Withdrawal Symptoms and Rebound Insomnia Upon Discontinuation of Daridorexant in Patients with Insomnia

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A139-A139
Author(s):  
Damien Leger ◽  
Ingo Fietze ◽  
Scott Pain ◽  
Dalma Seboek Kinter ◽  
Bruno Flamion ◽  
...  
Keyword(s):  
Sleep Onset ◽  
Sleep Time ◽  
Withdrawal Symptoms ◽  
Double Blind ◽  
Rebound Effects ◽  
Rebound Insomnia ◽  
Abrupt Discontinuation ◽  
Placebo Trial ◽  
Benzodiazepine Withdrawal ◽  
To Receive

Abstract Introduction Abrupt discontinuation of sleep medications in patients with insomnia often causes withdrawal symptoms and rebound insomnia. In a Phase 3 program evaluating efficacy and safety of daridorexant on sleep and daytime functioning in patients with insomnia during 3 months of treatment, the risks of withdrawal symptoms and rebound insomnia were evaluated at treatment cessation. Methods In two randomized, double-blind, 3-month trials, adult (18–64 years) and elderly (≥65) patients with insomnia were assigned (1:1:1) to receive oral daridorexant 25mg, 50mg or placebo (Trial-1, NCT03545191) or 10mg, 25mg or placebo (Trial-2, NCT03575104) every evening. Each trial included a 7-day, single-blind, placebo run-out period following double-blind treatment to evaluate withdrawal symptoms and rebound insomnia. Withdrawal effects were assessed by the change in Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) total score, from last assessment on double-blind treatment to end of placebo run-out, and occurrence of relevant adverse events (AEs). Rebound insomnia was assessed objectively by change in wake-after-sleep-onset (WASO) and latency-to-persistent sleep (LPS), from baseline to first night of placebo run-out, and by subjective total-sleep-time (sTST), from baseline to end of run-out (mean of 7-days). Analyses included all patients who received ≥1 dose of placebo run-out treatment (Trial-1: N=852; Trial-2: N=851). Results No increase in mean BSWQ score from last assessment on double-blind treatment to end of placebo run-out was reported (Trial-1: 25mg, -0.6±2.3; 50mg, -0.6±2.3; placebo, -0.7±2.3; Trial-2: 10mg, -0.5±2.6; 25mg, -0.4±1.9; placebo, -0.4±1.4). No patients had a BWSQ score &gt;20 at end of run-out. No AEs suggestive of withdrawal symptoms were reported. Mean WASO and LPS values (min) decreased from baseline to placebo run-out (WASO Trial-1: 25mg, -8.6±55.5; 50mg, -2.5±52.4; placebo, -20.4±45.8; Trial-2: 10mg, -11.6±58.3; 25mg, -5.1±57.9; placebo, -26.2±53.5; LPS Trial-1: 25mg, -17.2±56.7; 50mg, -15.0±55.8; placebo, -27.8±47.2; Trial-2: 10mg, -17.3±67.2; 25mg, -10.3±67.3; placebo, -18.3±63.8) while sTST values (min) increased (Trial-1: 25mg, 43.3±53.8; 50mg, 42.9±59.6; placebo, 42.3±52.7; Trial-2: 10mg, 43.3±52.9; 25mg, 46.8±55.4; placebo, 42.3±53.8) indicating absence of rebound effects. Conclusion Treatment with daridorexant for up to 3-months was not associated with any evidence of drug withdrawal or rebound insomnia upon abrupt discontinuation, indicating no safety concerns for patients should treatment be stopped. Support (if any) Funded by Idorsia Pharmaceuticals Ltd.

scholarly journals Effects of Perioperative Rosuvastatin for Postoperative Delirium After Elderly General Anesthesia Patients: A Randomized, Double-Blind, and Placebo-Controlled Trial

2021 ◽  
Author(s):  
Xiaoqin Xu ◽  
Jingzhi Luo ◽  
Xiaoyu Li ◽  
Haiqin Tang ◽  
Weihong Lu
Keyword(s):  
Clinical Trials ◽  
General Anesthesia ◽  
Clinical Outcomes ◽  
Postoperative Delirium ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Care Providers ◽  
Double Blind ◽  
Significant Difference ◽  
To Receive

Abstract Background: Experimental evidence has indicated the benefits of statins for the treatment of postoperative delirium. Previously clinical trials had no definite conclusions of statins on delirium. Some clinical trials indicated statins can reduce postoperative delirium and improve outcome, while some studies showed negative results. Therefore, the present study tries to evaluate whether perioperative rosuvastatin treatment could reduce the incidence of delirium and improve clinical outcomes. Methods: This was a randomized, double-blind, and placebo-controlled trial in a single-center in Jiangsu, China. This study enrolled patients aged more than 60 years old who present selective general anesthesia operation, with informed consent. A computer-generated randomization sequence (in a 1:1 ratio) was used to randomly assign patients to receive either rosuvastatin (40 mg/day) or placebos. Participants, care providers, and investigators were all masked to group assignment. The primary endpoint was the incidence of delirium, assessed twice daily with the Confusion Assessment Method during the first 7 postoperative days. Analyses were performed by intention-to-treat and safety populations. Results: Between Jan 1, 2017, and Jan 1, 2020, 3512 patients were assessed. A total of 821 were randomly assigned to receive either a placebo (n=411) or rosuvastatin (n=410). The incidence of postoperative delirium was significantly lower in the rosuvastatin group (23 [5.6%] of 410 patients) than the placebo group (42 [13.5%] of 411 patients (OR=0.522, 95% CI 0.308-0.885; p<0.05). No significant difference on 30-day all-cause mortality (6.1% vs 8.7 %, OR 0.67, P=0.147, 95% CI 0.39–1.2) between two groups. Rosuvastatin can decrease the hospitalization time (13.8±2.5 vs 14.2±2.8, P=0.03) and hospitalization expenses (9.3±2.5 vs 9.8±2.9, P=0.007). No statistical significance between the two groups on abnormal liver enzymes (9.0% vs 7.1%, P=0.30, OR=1.307, 95% CI 0.787-2.169) and rhabdomyolysis (0.73% vs 0.24%, P=0.37, OR=3.020, 95% CI 0.31-29.2. Conclusion: The current study suggests that perioperative rosuvastatin treatment can reduce the incidence of delirium after elective general anesthesia operation. However, no evidence was found that rosuvastatin can improve clinical outcomes. The therapy was safe. Further investigation is necessary to fully understand the potential usefulness of dexmedetomidine in older patients. Trial registration: chictr.org.cn, ChiCTR-IPR-17011984(Registered date: 13/07/2017). The manuscript adheres to CONSORT guidelines.

A Double-Blind Placebo-Controlled Study of Buspirone in Diazepam Withdrawal in Chronic Benzodiazepine Users

1990 ◽  
Vol 157 (2) ◽  
pp. 232-238 ◽  
Author(s):  
C. H. Ashton ◽  
M. D. Rawlins ◽  
S. P. Tyrer
Keyword(s):  
Controlled Trial ◽  
Dropout Rate ◽  
Withdrawal Symptoms ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Diazepam Withdrawal ◽  
Benzodiazepine Withdrawal

A double-blind placebo-controlled trial of 23 chronic benzodiazepine users showed that overall, buspirone did not appear to be helpful in alleviating benzodiazepine withdrawal symptoms. Buspirone (5 mg t.d.s.) or placebo was administered for four weeks before, during and after diazepam withdrawal. Patients taking buspirone had a markedly higher dropout rate (seven out of 11) than those taking placebo (one out of 12). Mean daily diazepam dosage at entry was significantly higher in the buspirone group, but overall initial diazepam dosage was not related to outcome. Higher subjectively rated anxiety at the start of withdrawal was significantly related to higher dropout rate, irrespective of treatment, and was greater (although not significantly so) in the buspirone group.

Frühgeborene unter maschineller Beatmung: Immunmodulatorischer Effekt der präventiven Gabe von Azithromycin

2020 ◽  
pp. 1-3
Author(s):  
Maximilian Jorczyk
Keyword(s):  
Very Low Birth Weight ◽  
Controlled Trial ◽  
Preterm Neonates ◽  
Double Blind ◽  
Mechanically Ventilated ◽  
Before And After ◽  
Anti Inflammatory ◽  
To Receive ◽  
Therapeutic Possibilities ◽  
Inflammatory Effect

<b>Introduction:</b> Macrolides have anti-inflammatory and immunomodulatory properties that give this class of antibiotics a role that differs from its classical use as an antibiotic, which opens new therapeutic possibilities. <b>Objective:</b> The aim of this study was to evaluate the anti-inflammatory effect of azithromycin in preventing mechanical ventilation (MV)-induced lung injury in very-low-birth-weight preterm neonates. <b>Methods:</b> This is a randomized, double-blind, placebo-controlled trial of preterm neonates who received invasive MV within 72 h of birth. Patients were randomized to receive intravenous azithromycin (at a dose of 10/mg/kg/day for 5 days) or placebo (0.9% saline) within 12 h of the start of MV. Two blood samples were collected (before and after intervention) for measurement of interleukins (ILs) and PCR for <i>Ureaplasma</i>. Patients were followed up throughout the hospital stay for the outcomes of death and bronchopulmonary dysplasia defined as need for oxygen for a period of ≥28 days of life (registered at ClinicalTrials.gov, No. NCT03485703). <b>Results:</b> Forty patients were analyzed in the azithromycin group and 40 in the placebo group. Five days after the last dose, serum IL-2 and IL-8 levels dropped significantly in the azithromycin group. There was a significant reduction in the incidence of death and O<sub>2</sub> dependency at 28 days/death in azithromycin-treated patients regardless of the detection of <i>Ureaplasma</i> in blood. <b>Conclusions:</b> Azithromycin has anti-inflammatory effects, with a decrease in cytokines after 5 days of use and a reduction in death and O<sub>2</sub> dependency at 28 days/death in mechanically ventilated preterm neonates.

scholarly journals Efficacy of Oral Acetaminophen and Intravenous Chlorpheniramine Maleate versus Placebo to Prevent Red Cell Transfusion Reactions in Children and Adolescent with Thalassemia: A Prospective, Randomized, Double-Blind Controlled Trial

Anemia ◽  
2018 ◽  
Vol 2018 ◽  
pp. 1-8 ◽  
Author(s):  
Piya Rujkijyanont ◽  
Chalinee Monsereenusorn ◽  
Pimpat Manoonphol ◽  
Chanchai Traivaree
Keyword(s):  
Blood Transfusion ◽  
Controlled Trial ◽  
Febrile Reaction ◽  
Chlorpheniramine Maleate ◽  
Clinical Trial Registry ◽  
Double Blind ◽  
Urticarial Rash ◽  
To Receive ◽  
Transfusion Reactions ◽  
Rbc Transfusion

Background. Thalassemia is a common congenital hemolytic disorder. In severe cases, regular blood transfusion is essentially required. The role of premedications to prevent transfusion reactions is varied among institutions with no standard guideline. Objective. To prospectively compare the risk of transfusion reactions in thalassemia patients premedicated with acetaminophen and chlorpheniramine maleate (CPM) versus placebo prior to blood transfusion. Material and Method. A randomized, double-blinded, placebo-controlled transfusion reaction study of 147 eligible patients was analyzed. All administered red blood cell (RBC) products were leukoreduced blood products. Patients were monitored and followed for the development of transfusion reactions for 24 hours after RBC transfusion. Results. A total of 73 patients randomized to receive active drugs consisting of acetaminophen and CPM were compared to 74 patients receiving placebo. The overall incidences of febrile reaction and urticarial rash were 6.9% and 22% in the patients randomized to receive active drugs comparing with 9.5% and 35.2% in the patients receiving placebo with no significant differences between two groups. However, delayed development of urticarial rash at 4-24 hours after RBC transfusion was significantly higher in female and patients receiving placebo. Conclusion. Administration of premedications in thalassemia patients receiving RBC transfusion without a history of transfusion reactions does not decrease the overall risk of transfusion reactions. However, the use of CPM might be beneficial to prevent delayed urticarial rash in those patients especially in females (Thai Clinical Trial Registry (TCTR) study ID: 20140526001).

scholarly journals Effect of oral sugar solution for reducing pain in infants underwent diphtheria, pertussis, tetanus (DPT) im- munization: a randomized, double-blind controlled trial

2008 ◽  
Vol 48 (1) ◽  
pp. 23 ◽  
Author(s):  
Arief Priambodo ◽  
Madarina Julia ◽  
Djauhar Ismail
Keyword(s):  
Median Duration ◽  
Controlled Trial ◽  
Intervention Group ◽  
Oral Solution ◽  
Health Centers ◽  
Sugar Solution ◽  
Negative Effects ◽  
Double Blind ◽  
Primary Health ◽  
To Receive

Background Infants are often subjected to painful procedures suchas diphtheria, pertussis, tetanus (DTP) immunization. Despiteits negative effects, pain in infants has not got enough attention.Sweet oral solution has analgesic effect.Objective To determine whether oral sugar solution can reducethe duration of crying in infants who got DTP immunization.Methods This was a randomized, double-blind controlled trialperformed at Growth and Development Clinic of Dr. SardjitoGeneral Hospital and two Primary Health Centers in Yogyakarta.Study subjects were 4-6 month-old infants who got the 3 rd DTPimmunization. Subjects were randomly allocated to receive 2 ml75% oral sugar solution (intervention group) or 2 ml drinkingwater (placebo) just before the immunization. Crying was recordedfrom just before the injection until 3 minutes after.Results Eighty-six subjects were enrolled; 42 subjects receivedsugar solution and 44 subjects received placebo. Sugar solutionreduced the median duration of first cry about 38 seconds or 32%(P=0.03) and reduced the median duration of total crying about35 seconds or 24% (P=0.02).Conclusion Administration of 2 ml 75% oral sugar solution canalleviate pain associated with DTP immunization as shown byreduced duration of crying.

A double-blind placebo-controlled trial of perioperative prophylactic antibiotics for elective neurosurgery

1988 ◽  
Vol 69 (5) ◽  
pp. 687-691 ◽  
Author(s):  
Ross Bullock ◽  
James R. van Dellen ◽  
William Ketelbey ◽  
S. Gustav Reinach
Keyword(s):  
Controlled Trial ◽  
Prophylactic Antibiotics ◽  
Risk Of Infection ◽  
Broad Spectrum Antibiotic ◽  
Wound Sepsis ◽  
Double Blind ◽  
Content Type ◽  
Exact Test ◽  
Significant Difference ◽  
To Receive

✓ In this study, 417 patients undergoing “clean” elective neurosurgical operative procedures were randomized to receive a broad-spectrum antibiotic (piperacillin) or placebo given as three perioperative doses, each 6 hours apart. Randomization was carried out by hospital pharmacists, and the investigators remained blinded until the end of the study. Twenty cases were excluded from analysis because either an unforeseen second operation was performed or antibiotic therapy was initiated within 30 days after surgery to treat infection or the risk of infection. Twelve of the 205 patients treated with placebo developed postoperative wound sepsis, and four of the 192 piperacillin-treated patients developed wound sepsis — a statistically significant difference (p < 0.05, Fisher's exact test). Piperacillin thus appeared to reduce the incidence of neurosurgical wound infection in this study.

Metronidazole in the Treatment of Alcohol Addiction A Controlled Trial

1968 ◽  
Vol 114 (509) ◽  
pp. 473-475 ◽  
Author(s):  
M. G. Gelder ◽  
Griffith Edwards
Keyword(s):  
Controlled Trial ◽  
Alcohol Addiction ◽  
Withdrawal Symptoms ◽  
Double Blind

Metronidazole (‘Flagyl’) has recently been said to be of value in treating alcoholism (Taylor, 1964). The drug is, of course, better known for its use against trichomoniasis. Three main claims have been made about it: (a) that it has an effect like disulfiram (Taylor, 1964; Bonfiglio and Donadio, 1966; Lehman, Ban and Nalchayan, 1966); (b) that it cuts short withdrawal symptoms (Lehmanet al., 1966); (c) that it reduces craving and thereby allows return to normal drinking (Lehman,et al., 1966; Elosuo, 1966; Bonfiglio and Donadio, 1966). It is this last claim that is particularly important, since other well-tried preparations are in use for the first two purposes. We report a double-blind controlled trial directed to the possible disulfiram-like effects of the drug, and to its ability to reduce craving.

scholarly journals Efficacy of a nasal spray containing Iota-Carrageenan in the prophylaxis of COVID-19 in hospital personnel dedicated to patients care with COVID-19 disease. A pragmatic multicenter, randomized, double-blind, placebo-controlled trial (CARR-COV-02)

2021 ◽  
Author(s):  
Juan Manuel Figueroa ◽  
Monica Lombardo ◽  
Ariel Dogliotti ◽  
Luis Flynn ◽  
Robert P. Giugliano ◽  
...  
Keyword(s):  
Placebo Group ◽  
Nasal Spray ◽  
Controlled Trial ◽  
Hospital Personnel ◽  
Culture Methods ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Significant Efficacy ◽  
To Receive

Background Iota-Carrageenan (I-C) is a sulfate polysaccharide synthesized by red algae, with demonstrated antiviral activity and clinical efficacy as nasal spray in the treatment of common cold. In vitro, I-C inhibits SARS-CoV-2 infection in cell culture. Methods This is a pragmatic multicenter, randomized, double-blind, placebo-controlled trial assessing the use of a nasal spray containing I-C in the prophylaxis of COVID-19 in hospital personnel dedicated to care of COVID-19 patients. Clinically healthy physicians, nurses, kinesiologists and others medical providers were assigned in a 1:1 ratio to receive four daily doses of I-C spray or placebo for 21 days. The primary end point was clinical COVID-19, as confirmed by reverse-transcriptase-polymerase-chain-reaction testing, over a period of 21 days. The trial is registered at ClinicalTrials.gov (NCT04521322). Findings A total of 394 individuals were randomly assigned to receive I-C or placebo. Both treatment groups had similar baseline characteristics. The incidence of COVID-19 was significantly lower in the I-C group compared to placebo (1.0% vs 5.0%) (Odds Ratio 0.19 (95% confidence interval 0.05 to 0.77; p= 0.03). Workday loss in placebo group compared to I-C were 1.6% days / person (95% CI, 1.0 to 2.2); p <0.0001 There were no differences in the incidence of adverse events across the two groups (17.3% in the I-C group and 15.2% in the placebo group, p= 0.5). Interpretation I-C showed significant efficacy in preventing SARS-CoV-2 infection in hospital personnel dedicated to care patients with COVID-19 disease.

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