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 @ 10:13 PM
Ignite Modification Date:
2025-12-24 @ 10:13 PM
NCT ID:
NCT00640835
Eligibility Criteria:
Inclusion Criteria:
Subjects must:
* Be 18-to-65 years of age, inclusive.
* Have a diagnosis of opioid dependence by medical history according to DSM-IV-TR criteria.
* Be on stable dose of 4 to 32 mg (expressed as the buprenorphine component)daily of Suboxone for at least 30 days.
* If female, have a negative pregnancy test during screening and agree to use an acceptable method of birth control which may include:
Exclusion Criteria:
Subjects must not:
* Have participated in an experimental drug or device study within the last 30 days.
* If female, be breast feeding or lactating.
* Have any medical condition that in the opinion of the physician investigator would preclude the subject from completing the study.
* Have a clinically significant abnormal finding (in the opinion of the Investigator) on oral cavity exam (e.g., active mouth ulcers).
* Have any piercing of the tongue or mouth within 30 days prior to the first dose of study medication.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00640835
Study Brief:
Protocol Section:
NCT00640835