Heroin DependenceNCT01668706
Pharmacogenomics Study of Sleep Disturbance and Neurocognitive Impairments in the Opioid Addicts
An observational study of Heroin Dependence, run by National Health Research Institutes, Taiwan at 5 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Heroin Dependence
- How many people
- 340 participants
- Where
- 5 sitesTaiwan
- Study dates
- Mar 2009to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
- Chinese ethnicity
- Men or women above age of 20, below age of 65
Show all 25Show fewer
- 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
- 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
- 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
Who cannot join
- 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
Show all 25Show fewer
- Methadone maintenance treatment group (MMT)
- Patients with comorbid severe mental disorders including:
- Organic mental disorders, or
- Schizophrenia
- Severe cognitive impairment
- Being pregnant
- Buprenorphine/Naloxone treatment group (BNT)
- Patients with comorbid severe mental disorders including:
- Organic mental disorders, or
- Schizophrenia
- Severe cognitive impairment
- Being pregnant
- Medication-free ex-addict group (MF)
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Taiwan5 sites
Far Eastern Memorial Hospital
Banqiao District, New Taipei City, 22060
Far Eastern Memorial Hospital
Banqiao District, New Taipei, 22060
ChangHua Christian Hospital
Lukang, ChangHua, 50550
National Health Research Institute
Miaoli County, Taiwan, 35053
En-Chu-Gong Hospital
Sanxia District, New Taipei, 23702
About this study
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
- Medical subject headings
- Heroin Dependence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Methadone maintenance treatment (MMT) | Not described | |
| Buprenorphine-Naloxone treatment (BNT) | Not described | |
| Medication-free ex-addicts(MF) | Not described | |
| Normal control (NC) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Group differences in demopraphics
support system, vital sign, substance use history
Measured: one year
Secondary outcomes (1)
Gruop differences in neuro-cognitive functions
attention, executive function, decision making
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
- Study startMar 2009
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heroin DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sheng-Chang Wang, M.D., M.Sc., Principal investigator, National Health Research Institutes, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01668706
- Sponsor's protocol ID
- MD098SCW01
- Status last verified
- Aug 2012
- First submitted
- 16 Aug 2012
- Last updated
- 9 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenomics Study of Sleep Disturbance and Neurocognitive Impairments in the Opioid Addicts
- ClinicalTrials.gov ID
- NCT01668706
- Acronym / sponsor ID
- MD098SCW01
- Conditions
- Heroin Dependence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 20 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Methadone maintenance treatment (MMT) | – | – |
| Buprenorphine-Naloxone treatment (BNT) | – | – |
| Medication-free ex-addicts(MF) | – | – |
| Normal control (NC) | – | – |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (25 listed)
- 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
Key exclusion criteria (25 listed)
- Methadone maintenance treatment group (MMT)
- Buprenorphine/Naloxone treatment group (BNT)
- Medication-free ex-addict group (MF)
- Patients with comorbid severe mental disorders including:
- Severe cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Group differences in demopraphics
Time frame: one year
support system, vital sign, substance use history
1 secondary outcome
Gruop differences in neuro-cognitive functions
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheng-Chang Wang, M.D., M.Sc. principal investigator
National Health Research Institutes, Taiwan
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heroin Dependence, run by National Health Research Institutes, Taiwan at 5 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Group differences in demopraphics (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2016.