Completed

NCT Number: NCT01668706

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

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.

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Key information

Conditions

Heroin Dependence Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

ChangHua Christian Hospital, Lukang, ChangHua, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Normal control group (NC):

Inclusion criteria

Chinese ethnicity
Men or women above age of 20
Able to participate in a clinical assessment in Chinese (including Mandarin and Taiwanese dialects)
Individuals who have completed a written consent form

Exclusion criteria

Patients with comorbid severe mental disorders including:

Organic mental disorders, or
Schizophrenia
Past diagnosis of Heroin dependence by DSM-IV definition
Severe cognitive impairment
Being pregnant
Methadone maintenance treatment group (MMT)

Inclusion criteria

Chinese ethnicity
Men or women above age of 20, below age of 65
Able to participate in a clinical assessment in Chinese (including Mandarin and Taiwanese dialects)
Diagnosis of Heroin dependence by DSM-IV definition
Enter methadone maintenance therapy for at least 3 months
No change of methadone dosage for the last week
Regularly took methadone for the last week
Individuals who have completed a written consent form

Exclusion criteria

Patients with comorbid severe mental disorders including:

Organic mental disorders, or
Schizophrenia
Severe cognitive impairment
Being pregnant
Buprenorphine/Naloxone treatment group (BNT)

Inclusion criteria

Chinese ethnicity
Men or women above age of 20, below age of 65
Able to participate in a clinical assessment in Chinese (including Mandarin and Taiwanese dialects)
Diagnosis of Heroin dependence by DSM-IV definition
Enter buprenorphine maintenance therapy for at least 3 months
No change of buprenorphine dosage for the last week
Regularly took buprenorphine for the last week
Individuals who have completed a written consent form

Exclusion criteria

Patients with comorbid severe mental disorders including:

Organic mental disorders, or
Schizophrenia
Severe cognitive impairment
Being pregnant
Medication-free ex-addict group (MF)

Inclusion criteria

Chinese ethnicity
Men or women above age of 20
Able to participate in a clinical assessment in Chinese (including Mandarin and Taiwanese dialects)
Diagnosis of Heroin dependence by DSM-IV definition
Individuals who have completed a written consent form

Exclusion criteria

Patients with comorbid severe mental disorders including:

Organic mental disorders, or
Schizophrenia
Severe cognitive impairment
Being pregnant
Exposure of methadone, buprenorphine and other opioid treatment in the previous 3 months

Treatment and study plan

Primary outcomes

Group differences in demopraphics

Time frame: one year

support system, vital sign, substance use history

Secondary outcomes

Gruop differences in neuro-cognitive functions

Time frame: one year

attention, executive function, decision making

Sponsors and collaborators

Lead sponsor

National Health Research Institutes, Taiwan

Other

Registry information

Important dates

Study start: 2009
Primary completion: 2013
Study completion: 2013
First posted: Aug 20, 2012
Registry last updated: Nov 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed