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

NCT01668706 | Completed

• 1 other identifier: MD098SCW01
• Study Type: observational
• Target: 340
• Locations: 1 country
• Sites: 5

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.

Conditions

Heroin Dependence

Outcome Measures

Primary Outcomes (1)

• Group differences in demopraphics

  support system, vital sign, substance use history

  one year

Secondary Outcomes (1)

• Gruop differences in neuro-cognitive functions

  one year

Study Arms (4)

Methadone maintenance treatment (MMT)

Buprenorphine-Naloxone treatment (BNT)

Medication-free ex-addicts(MF)

Normal control (NC)

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead

Study Sites (5)

ChangHua Christian Hospital

Lukang, ChangHua, 50550, Taiwan

Location

Far Eastern Memorial Hospital

Banqiao District, New Taipei City, 22060, Taiwan

Location

Far Eastern Memorial Hospital

Banqiao District, New Taipei, 22060, Taiwan

Location

En-Chu-Gong Hospital

Sanxia District, New Taipei, 23702, Taiwan

Location

National Health Research Institute

Miaoli County, Taiwan, 35053, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

plasma, DNA and urine

MeSH Terms

Conditions

Heroin Dependence

Condition Hierarchy (Ancestors)

Opioid-Related Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Sheng-Chang Wang, M.D., M.Sc.

  National Health Research Institutes, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2012
• First Posted: August 20, 2012
• Study Start: March 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 9, 2016

Record last verified: 2012-08

Locations

TW (5)