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Lofexidine for Inpatient Opiate Detox in Singapore

NCT01675648 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2015-08-28

No results posted yet for this study

Summary

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.

Conditions

  • Opiate Dependent Patients Who Are Undergoing Inpatient Detoxification in Singapore

Interventions

DRUG

Lofexidine

DRUG

Diazepam

DRUG

Placebo for Lofexidine

DRUG

Placebo for Diazepam

Sponsors & Collaborators

  • Singapore Clinical Research Institute

    collaborator OTHER

  • Institute of Mental Health, Singapore

    lead OTHER

Principal Investigators

  • Song Guo, Ph.D · NAMS IMH Singapore

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01675648 on ClinicalTrials.gov