Pharmacogenomics Study of Sleep Disturbance and Neurocognitive Impairments in the Opioid Addicts

Completed

• Conditions: Heroin Dependence

• Registration Number: NCT01668706
• Lead Sponsor: National Health Research Institutes, Taiwan

Brief Summary

Opioid abuse is a complex problem, which not only impacts on addicts' physical and psychological health individually, but also threats the society. Recently, spread of HIV via sexual behavior and needle sharing among injecting drug users (IDUs) also becomes a serious public health problem all over the world. In Taiwan, since the first HIV-infected IDU identified in 1987, the incident cases have mounted to 2,461 in 2005. To prevent the epidemics of HIV among IDUs, the Center for Disease Control (CDC) thus collaborated with Department of Justice and implemented harm reduction programs in 2005. It is the milestone that opioid addiction is officially treated as a health rather than a legal issue in Taiwan. Among the harm reduction programs of needle and syringe exchange for IDUs as well as substitution treatment for opioid dependence, methadone maintenance treatment (MMT) is one of the most important parts. Till 2008, there were over 13,000 heroin addicts participated in more than 80 MMT programs.

Although the clinical evidences have proven the superior effectiveness of maintenance therapy in ameliorating illicit substances abuse, decreasing criminality and improving quality of life, there are common problems of sleep disturbance and neurocognitive impairments among the subjects receiving opioid medications. The concerns of the adverse effects might thus frustrate the subjects' motivation and compliance to maintain treatments. However, sleep disturbance and neurocognitive impairments related to opioid medications are often neglected in the clinical practices and there are scanty researches focusing on these crucial issues in the existing literature.

In this prospective study, four groups of subjects including methadone maintenance treatment, buprenorphine/naloxone, medication-free opioid ex-addicts and healthy volunteers will be enrolled. Via the comprehensive assessments including clinical interview, neurocognitive examinations, electrocardiogram-based sleep breathing detector and pharmacogenomical evaluation, we will not only have the opportunities to have more insights on the impacts of opioid medications on sleep and neurocognitive performances, but also develop more adequate strategies to improve motivation and outcome in treating the opioid addicts.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Status Verified: 2012-08
• Study First Submitted: 2012-08-16
• Study First Submitted QC: 2012-08-16
• Study First Posted: 2012-08-20
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Last Update Submitted: 2016-11-08
• Last Update Posted: 2016-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Group differences in demopraphics	one year	support system, vital sign, substance use history

Secondary Outcome Measures

Name	Time	Method
Gruop differences in neuro-cognitive functions	one year	attention, executive function, decision making

Trial Locations

Locations (4)

Far Eastern Memorial Hospital; 🇨🇳 Banqiao, New Taipei, Taiwan

National Health Research Institute; 🇨🇳 Miaoli County, Taiwan

ChangHua Christian Hospital; 🇨🇳 Lukang, ChangHua, Taiwan

En-Chu-Gong Hospital; 🇨🇳 Sanxia, New Taipei, Taiwan