Heroin Dependence Clinical Trial
Official title:
Pharmacogenomics Study of Sleep Disturbance and Neurocognitive Impairments in the Opioid Addicts
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.
n/a
Observational Model: Cohort, Time Perspective: Prospective
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