An observational study in Heroin Dependence, sponsored by National Health Research Institutes, Taiwan. Completed at 5 sites in Taiwan. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-09.
Sponsored by National Health Research Institutes, Taiwan · Observational
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.
324 studies on the registry are indexed under Dyssomnias; 51 are open to participants now.
This study's enrollment of 340 is above the median of 126 across 63 observational studies indexed under Dyssomnias.
Browse Dyssomnias studies →National Health Research Institutes, Taiwan is the lead sponsor of 125 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Normal control group:
Healthy adults will be recruited from community.
Normal control group (NC):
Inclusion criteria:
Exclusion criteria:
Patients with comorbid severe mental disorders including:
Methadone maintenance treatment group (MMT)
Inclusion criteria:
Exclusion criteria:
Patients with comorbid severe mental disorders including:
Buprenorphine/Naloxone treatment group (BNT)
Inclusion criteria:
Exclusion criteria:
Patients with comorbid severe mental disorders including:
Inclusion criteria:
Exclusion criteria:
Patients with comorbid severe mental disorders including:
Group differences in demopraphics
support system, vital sign, substance use history
Time frame: one year
Gruop differences in neuro-cognitive functions
attention, executive function, decision making
Time frame: one year
This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Health Research Institutes, Taiwan