Pharmacogenomics Study of Sleep Disturbance and Neurocognitive Impairments in the Opioid Addicts
Condition: Heroin Dependence
MeSH terms: Dyssomnias; Parasomnias; Heroin Dependence
Study type: Observational

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.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        1. Normal control group:

             Healthy adults will be recruited from community.

          2. Methadone Maintenance treatment group Study subjects will be enrolled only in the
             methadone clinic.

          3. Buprenorphine/Naloxone treatment group Subjects will be enrolled only in the clinic.

          4. Drug-free ex-addict group Subjects will be recruited from the therapeutic communities
             and halfway house of Operation Dawn.
      
Biospecimen description: 
      plasma, DNA and urine