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

Sponsor
National Health Research Institutes, Taiwan (Other)
Overall Status
Completed
CT.gov ID
NCT01668706
Collaborator
(none)
340
Enrollment
5
Locations
57
Duration (Months)
68
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    340 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Pharmacogenomics Study of Sleep Disturbance and Neurocognitive Impairments in the Opioid Addicts
    Study Start Date :
    Mar 1, 2009
    Actual Primary Completion Date :
    Dec 1, 2013
    Actual Study Completion Date :
    Dec 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    Methadone maintenance treatment (MMT)
    Buprenorphine-Naloxone treatment (BNT)
    Medication-free ex-addicts(MF)
    Normal control (NC)

    Outcome Measures

    Primary Outcome Measures

    1. Group differences in demopraphics [one year]

      support system, vital sign, substance use history

    Secondary Outcome Measures

    1. Gruop differences in neuro-cognitive functions [one year]

      attention, executive function, decision making

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    1. Normal control group (NC):
    Inclusion criteria:

    1. Chinese ethnicity

    2. Men or women above age of 20

    3. Able to participate in a clinical assessment in Chinese (including Mandarin and Taiwanese dialects)

    4. Individuals who have completed a written consent form

    Exclusion criteria:

    1. Patients with comorbid severe mental disorders including:

    2. Organic mental disorders, or

    3. Schizophrenia

    4. Past diagnosis of Heroin dependence by DSM-IV definition

    5. Severe cognitive impairment

    6. Being pregnant

    7. Methadone maintenance treatment group (MMT)

    Inclusion criteria:

    1. Chinese ethnicity

    2. Men or women above age of 20, below age of 65

    3. Able to participate in a clinical assessment in Chinese (including Mandarin and Taiwanese dialects)

    4. Diagnosis of Heroin dependence by DSM-IV definition

    5. Enter methadone maintenance therapy for at least 3 months

    6. No change of methadone dosage for the last week

    7. Regularly took methadone for the last week

    8. Individuals who have completed a written consent form

    Exclusion criteria:

    1. Patients with comorbid severe mental disorders including:

    2. Organic mental disorders, or

    3. Schizophrenia

    4. Severe cognitive impairment

    5. Being pregnant

    6. Buprenorphine/Naloxone treatment group (BNT)

    Inclusion criteria:

    1. Chinese ethnicity

    2. Men or women above age of 20, below age of 65

    3. Able to participate in a clinical assessment in Chinese (including Mandarin and Taiwanese dialects)

    4. Diagnosis of Heroin dependence by DSM-IV definition

    5. Enter buprenorphine maintenance therapy for at least 3 months

    6. No change of buprenorphine dosage for the last week

    7. Regularly took buprenorphine for the last week

    8. Individuals who have completed a written consent form

    Exclusion criteria:

    1. Patients with comorbid severe mental disorders including:

    2. Organic mental disorders, or

    3. Schizophrenia

    4. Severe cognitive impairment

    5. Being pregnant

    6. Medication-free ex-addict group (MF)

    Inclusion criteria:

    1. Chinese ethnicity

    2. Men or women above age of 20

    3. Able to participate in a clinical assessment in Chinese (including Mandarin and Taiwanese dialects)

    4. Diagnosis of Heroin dependence by DSM-IV definition

    5. Individuals who have completed a written consent form

    Exclusion criteria:

    1. Patients with comorbid severe mental disorders including:

    2. Organic mental disorders, or

    3. Schizophrenia

    4. Severe cognitive impairment

    5. Being pregnant

    6. Exposure of methadone, buprenorphine and other opioid treatment in the previous 3 months

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ChangHua Christian Hospital Lukang ChangHua Taiwan 50550
    2 Far Eastern Memorial Hospital Banqiao New Taipei City Taiwan 22060
    3 Far Eastern Memorial Hospital Banqiao New Taipei Taiwan 22060
    4 En-Chu-Gong Hospital Sanxia New Taipei Taiwan 23702
    5 National Health Research Institute Miaoli County Taiwan 35053

    Sponsors and Collaborators

    • National Health Research Institutes, Taiwan

    Investigators

    • Principal Investigator: Sheng-Chang Wang, M.D., M.Sc., National Health Research Institutes, Taiwan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Health Research Institutes, Taiwan
    ClinicalTrials.gov Identifier:
    NCT01668706
    Other Study ID Numbers:
    • MD098SCW01
    First Posted:
    Aug 20, 2012
    Last Update Posted:
    Nov 9, 2016
    Last Verified:
    Aug 1, 2012
    Additional relevant MeSH terms:
    Dyssomnias
    Parasomnias
    Heroin Dependence

    Study Results

    No Results Posted as of Nov 9, 2016