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 @ 12:17 PM
Ignite Modification Date:
2025-12-24 @ 12:17 PM
NCT ID:
NCT00571961
Eligibility Criteria:
Inclusion Criteria:
* Chronic BUP users enrolled in BUP program, receiving BUP for at least 3 months and on a stable BUP dose for at least 3 weeks.
* Acceptable medical history, physical examination, 12 lead electrocardiogram, and clinical laboratory evaluations consistent with BUP maintenance
* Subjects who meet the criteria of opiate dependence, are enrolled in long-term BUP maintenance therapy, and have been on a stable dose of BUP for at least 3 weeks.
* Body weight \>60 kg for males and \>40 kg for females
* Body Mass Index (BMI) of 18 to 30 kg/m2, inclusive. BMI = weight (kg)/ \[height (m)\]2.
* Male or females, ages 18 to 65 years.
* Women of childbearing potential (WOCBP) must not be nursing, pregnant and on adequate non-hormonal contraception to avoid pregnancy. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of Study Day 1.
Exclusion Criteria:
Sex and Reproductive Status Exceptions
* WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks before and after the study.
* WOCBP using a prohibited contraceptive method (oral, injectable, or implantable hormonal agents)
* Women who are pregnant or breastfeeding
* Women with a positive pregnancy test on enrollment or prior to study drug administration.
Medical History and Concurrent Diseases
* History or current evidence of any significant acute or chronic medical illness that, within the investigator's discretion, would interfere with the conduct or interpretation of the study.
* History of nephrolithiasis
* History of acute or chronic pancreatitis.
* History of uncontrolled chronic medical illness which could adversely affect the subject's adherence to study protocol or affect patient safety in the opinion of the investigator
* Use of any medication thought to significantly alter the metabolism of Kaletra, Buprenorphine or naloxone.
* History of any hemolytic disorders (including drug-induced hemolysis).
* Proven or suspected acute hepatitis at the time of study entry.
* Current or recent (within 3 months) gastrointestinal disease which would interfere with the conduct or interpretation of the study.
* Any major surgery within 4 weeks of enrollment. Minor surgical procedures requiring local anesthesia are exceptions.
* Any gastrointestinal surgery that could impact upon the absorption of study drug.
* Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within 4 weeks of enrollment.
* Blood transfusion within 4 weeks of enrollment.
* Inability to tolerate oral medication.
* Inability to tolerate venipuncture and/or absence of secure venous access.
* Inability to refrain from smoking during in-patient period
* Known or suspected HIV infection (subjects who are found to be positive upon screen for HIV will be excluded).
* Known active drug or alcohol abuse, which in the opinion of the investigator makes study participation to completion unlikely.
* Any other sound medical, psychiatric and/or social reason as determined by the Investigator.
Physical and Laboratory Test Findings
* Evidence of organ dysfunction or any clinically relevant deviations from the norms observed in a buprenorphine treated population in physical examination, vital signs, ECG or clinical laboratory determinations.
* Ingestion of alcohol within 24 hours prior to the dose of study medication
* Positive breathalyzer alcohol test, or positive urine screen for barbiturates, benzodiazepines, amphetamines or opiates other than buprenorphine.
* Positive blood screen for HIV antibody.
* QTc interval \>450 msec for males or \>470 msec for females.
* Second or third-degree AV block.
* Creatinine clearance(as estimated by method of Cockcroft and Gault) less than 80 mL/min.
* CLcr=0.85(females only)x(140-age)x weight(kg)
* serum creatinine(mg/dL)x 72
* Subjects with bilirubin \>2 mg/dL, serum albumin \<2.5 g/dL and ascites, AST and ALT \>3 times ULN, hemoglobin \<9 g/dL, and platelet count \<75,000/mm3.
* Positive serum or urine for HCG.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00571961
Study Brief:
Protocol Section:
NCT00571961