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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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

Detailed Summary:
Sponsor: National Health Research Institutes, Taiwan

Current Primary Outcome: Group differences in demopraphics [ Time Frame: one year ]

Original Primary Outcome:

Current Secondary Outcome: Gruop differences in neuro-cognitive functions [ Time Frame: one year ]

Original Secondary Outcome:

Information By: National Health Research Institutes, Taiwan

Dates:
Date Received: August 16, 2012
Date Started: March 2009
Date Completion:
Last Updated: November 8, 2016
Last Verified: August 2012