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

NCT ID: NCT01668706

Last Updated: 2016-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

340 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heroin Dependence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Methadone maintenance treatment (MMT)

No interventions assigned to this group

Buprenorphine-Naloxone treatment (BNT)

No interventions assigned to this group

Medication-free ex-addicts(MF)

No interventions assigned to this group

Normal control (NC)

No interventions assigned to this group

Eligibility Criteria

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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

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

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


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. Past diagnosis of Heroin dependence by DSM-IV definition
3. Severe cognitive impairment
4. Being pregnant
2. Methadone maintenance treatment group (MMT)

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)

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)


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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Health Research Institutes, Taiwan

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sheng-Chang Wang, M.D., M.Sc.

Role: PRINCIPAL_INVESTIGATOR

National Health Research Institutes, Taiwan

Locations

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ChangHua Christian Hospital

Lukang, ChangHua, Taiwan

Site Status

Far Eastern Memorial Hospital

Banqiao District, New Taipei City, Taiwan

Site Status

Far Eastern Memorial Hospital

Banqiao District, New Taipei, Taiwan

Site Status

En-Chu-Gong Hospital

Sanxia District, New Taipei, Taiwan

Site Status

National Health Research Institute

Miaoli County, Taiwan, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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MD098SCW01

Identifier Type: -

Identifier Source: org_study_id