Opiate Dependent Patients Who Are Undergoing Inpatient Detoxification in Singapore | Lofexidine for Inpatient Opiate Detox in Singapore
Opiate Dependent Patients Who Are Undergoing Inpatient Detoxification in Singapore research study
What is the primary objective of this study?
In Singapore, opiate substitution medication e.g. methadone is only licensed for use with specific population. The standard treatment is one week of detoxification assisted with diazepam and symptomatic treatment followed by one week of rehabilitation. However, diazepam is highly addictive and widely abused among heroin users and pharmacologically, does not reduce the physical and psychological craving for opioids which can trigger relapse. Many opiate patients undergoing inpatient detoxification leave prematurely (i.e. PID: patient initiated discharge) because of the severity of unpleasant withdrawal symptoms. The purpose of the study is to establish an alternative medication to reduce opiate withdrawal symptoms for use in Singapore by evaluating the clinical efficacy of Lofexidine versus Diazepam in the management of the opiate withdrawal syndrome during inpatient detoxification.
Who is eligible to participate?
Inclusion Criteria: 1. Patients who meet the DSM-IV criteria for a diagnosis of opiate dependence (as diagnosed by a NAMS psychiatrist). 2. Individuals are voluntarily undergoing inpatient opiate withdrawal treatment at the National Addictions Management Service (NAMS). 3. Agreeable to participating in the clinical trial and will provide written consent. 4. Males or females who are between the ages of 21-55 years. The lower limit of 21 years is in place because of lack of data on younger populations. The upper limit is set at 55 years as the likelihood of having co-morbid physical health problems is greater. 5. Individuals who have a positive urine screen for the presence of opiates (routinely given on first visit to outpatient clinic). Exclusion Criteria: 1. Are investigator site personnel directly affiliated with this study and their immediate families, immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted. 2. Are currently enrolled in, or discontinued within the last 30 days from another clinical trial or medical research judged not to be scientifically or medically compatible with this study. 3. A history of allergy/sensitivity to clonidine, lofexidine, imidazole derivatives (e.g. clotrimazole, antifungal) or alpha-2-adrenergic medications. 4. Co-dependency on alcohol, benzodiazepines or any other drug that would require detoxification. 5. A history of major physical illness (cardiovascular disease, cerebrovascular disease, renal impairment, liver disease, epilepsy, symptomatic HIV, Hepatitis B and/or C). 6. Patients with major psychiatric illness (e.g. psychotic disorders, major depression). 7. Patients prescribed analgesic*(*: Opioid analgesic and similar narcotic analgesics), antihypertensive, antiarrhythmic, or antiretroviral medication. 8. Baseline BP > 140/90 mmHg or < 85/55mmHg, and/or baseline PR <55beats/min. 9. Significant abnormal finding from blood tests (FBC, LFT, Renal function) and ECG during screening. 10. Pregnant or breast feeding. 11. Patients are receiving and not willing to stop the drugs which may cause prolong QT interval and hypotension while using concomitant with Lofexidine, e.g. thioridazine, chlorpromazine, tricyclic antidepressants.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Opiate Dependent Patients Who Are Undergoing Inpatient Detoxification in Singapore
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Placebo for Lofexidine
Drug:Placebo for Diazepam
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Initial Lofexidine dosage starts from 0.8mg per day, it will be gradually increased by increments of 0.4 to 0.8mg per day up to a maximum of 2.2mg daily. After 3 peak dose days, the dosage will be gradually decreased by 0.2 to 0.6mg per day till to 0.2mg of the last lofexidine dosage in Day 10. The Diazepam placebo will be administrated to the patients with the same frequency, time and number tablets of diazepam in the active comparator arm.
Start Date: August 2012
Completed Date: July 2015
Phase: Phase 4
Primary Outcome: To evaluate differences in OOWS (Objective Opiate Withdrawal Scale)
Secondary Outcome: To evaluate differences in SOWS (Short Opiate Withdrawal Scale)
Study sponsors, principal investigator, and references
Principal Investigator: Song Guo, Ph.D
Lead Sponsor: Institute of Mental Health, Singapore
Collaborator: Singapore Clinical Research Institute