Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2025-12-26 @ 5:18 PM
NCT ID:
NCT01668706
Eligibility 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
65 Years
Study:
NCT01668706
Study Brief:
Protocol Section:
NCT01668706