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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by National Health Research Institutes, Taiwan.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier:
NCT01668706
First received: August 16, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  Purpose

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
Heroin Dependence

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacogenomics Study of Sleep Disturbance and Neurocognitive Impairments in the Opioid Addicts

Resource links provided by NLM:


Further study details as provided by National Health Research Institutes, Taiwan:

Biospecimen Retention:   Samples With DNA

plasma, DNA and urine


Estimated Enrollment: 600
Study Start Date: March 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Methadone maintenance treatment (MMT)
Buprenorphine-Naloxone treatment (BNT)
Medication-free ex-addicts(MF)
Normal control (NC)

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
Criteria
  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:

      1. Organic mental disorders, or
      2. Schizophrenia
    2. Past diagnosis of Heroin dependence by DSM-IV definition
    3. Severe cognitive impairment
    4. Being pregnant
  2. 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:

      1. Organic mental disorders, or
      2. Schizophrenia
    2. Severe cognitive impairment
    3. Being pregnant
  3. 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:

      1. Organic mental disorders, or
      2. Schizophrenia
    2. Severe cognitive impairment
    3. Being pregnant
  4. 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:

    1. Organic mental disorders, or
    2. Schizophrenia
  2. Severe cognitive impairment
  3. Being pregnant
  4. Exposure of methadone, buprenorphine and other opioid treatment in the previous 3 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01668706

Contacts
Contact: Sheng-Chang Wang, M.D., M.Sc. 886-37-246166 ext 36703 scwang69@gmail.com

Locations
Taiwan
ChangHua Christian Hospital Recruiting
Lukang, ChangHua, Taiwan, 50550
Contact: Wen Yu Hsu, M.D.    886-4-7789595 ext 1281    400850@cch.org.tw   
Changhua Christian Hospital Recruiting
Lukang, Changhua, Taiwan, 50550
Contact: Chieh Hui Wang, M.D.    886-4-7789595 ext 1586    400807@cch.org.tw   
Changhua Christian Hospital Recruiting
Lukang, Changhua, Taiwan, 50550
Contact: Nan Ying Chiu, M.D.    886-4-7789595 ext 1130    400786@cch.org.tw   
Far Eastern Memorial Hospital Recruiting
Banqiao, New Taipei City, Taiwan, 22060
Contact: Kai Chi Fang, M.D.    886-2-89667000 ext 1603    kcfang@mail.femh.org.tw   
Far Eastern Memorial Hospital Recruiting
Banqiao, New Taipei, Taiwan, 22060
Contact: Chi Shin Wu, M.Sc.    886-2-89667000 ext 4039    elphinwu@yahoo.com.tw   
En-Chu-Gong Hospital Recruiting
Sanxia, New Taipei, Taiwan, 23702
Contact: Li Nen Lin, M.D.    886-2-26723456 ext 6001    linen.linenlin@gmail.com   
National Health Research Institute Recruiting
Miaoli County, Taiwan, 35053
Contact: Yu-Cheng Cheng, MPe    886-37-246-166 ext 36736    panpan0301@gmail.com   
Principal Investigator: Sheng-Chang Wang, M.D.,M.Sc.         
Sponsors and Collaborators
National Health Research Institutes, Taiwan
Investigators
Principal Investigator: Sheng-Chang Wang, M.D., M.Sc. National Health Research Institutes, Taiwan
  More Information

No publications provided

Responsible Party: National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier: NCT01668706     History of Changes
Other Study ID Numbers: MD098SCW01
Study First Received: August 16, 2012
Last Updated: August 16, 2012
Health Authority: Taiwan: National Health Research Institutes

Additional relevant MeSH terms:
Dyssomnias
Sleep Disorders
Parasomnias
Heroin Dependence
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on October 01, 2014