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:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-24 @ 5:53 PM
NCT ID:
NCT00032968
Eligibility Criteria:
Inclusion Criteria:
1. Treatment-seeking males and non-pregnant and non-lactating females, 15 years and older, who fulfill DSM-IV criteria for opiate dependence, report experiencing symptoms of opiate withdrawal, are currently physically dependent on opioids and are in need of medical assistance for opioid withdrawal.
2. Systolic blood pressure 100 mm Hg, and pulse 56 bpm.
3. Good general health or, in case of a medical/psychiatric condition needing ongoing treatment, under the care of a physician willing to continue patient's medical management and cooperate with the study physicians.
4. Agreeable to and capable of signing the informed consent approved by an institutional review board and, if under the age of 18 (excluding emancipated minors), assent and concurrent consent from a parent or legal guardian.
5. Use of one of the following acceptable methods of birth control by female patients of childbearing potential:
1. oral contraceptives
2. barrier (diaphragm or cervical cap) with spermicide or condom
3. intrauterine progesterone contraceptive system
4. levonorgestrel implant
5. medroxyprogesterone acetate contraceptive injection
6. complete abstinence from sexual intercourse
Exclusion Criteria:
1. Medical condition that would make participation, in the opinion of the study physician, medically hazardous (e.g., acute hepatitis, unstable cardiovascular, liver or renal disease);
2. Clinically significant abnormalities in ECG.
3. Known allergy or sensitivity to buprenorphine, naloxone, or clonidine.
4. Receiving beta-blockers, calcium channel blockers, tricyclics, digitalis and other medications which may interact adversely with clonidine.
5. Acute severe psychiatric condition in need of immediate treatment, or imminent suicide risk.
6. Dependence on alcohol, benzodiazepines or other depressants, or stimulants, and requiring immediate medical attention.
7. Participation in an investigational drug study, including buprenorphine, within the past 30 days.
8. Methadone or LAAM maintenance or detoxification within 30 days of enrollment.
9. Pending legal action that could prohibit or interfere with participation.
10. Unable to remain in area for duration of active phase of treatment.
11. Females that are pregnant, lactating, or planning to become pregnant.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Study:
NCT00032968
Study Brief:
Protocol Section:
NCT00032968