Interactions Between Intravenous Cocaine and Acetazolamide or Quinine
Completed · Phase 1
Conditions studied: Cocaine Use, Pharmacokinetics
In brief
Background: \- Scientists are studying medications that may be useful in treating cocaine addiction. It is important in these studies to know whether study participants are always taking their medications as directed. This study will look at two chemicals to see if they can be used to determine whether participants are taking their medications as directed. Because acetazolamide and quinine can be measured in plasma and urine, they are good test subjects for this study. They will be given alone, and combined with intravenous cocaine. Objectives: \- To see how they body handles acetazolamide and quinine alone, and when combined with cocaine. Eligibility: \- Individuals between 18 and 50 years of age who have smoked or used IV cocaine for at least one year and at least three times per month during the three months prior to screening. Urine test positive for cocaine within the prior 6 months Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will also be collected. * This study will involve a 12-day inpatient stay at the National Institutes of Health. * On days 1, 5, and 10, participants will receive a dose of cocaine. Blood, urine, breath, and saliva samples will be collected up to 18 times a day for up to about 24 hours. * On days 2, 3, 4, and 5, participants will receive acetazolamide. Regular blood samples will be collected on Day 4. * Day 6 is a wash-out day with no drugs or blood tests. * On days 7, 8, 9, and 10, participants will receive quinine. Regular blood samples will be collected on Day 9. * On day 11, blood, urine, breath, and saliva samples will be collected in the early morning. Participants will be able to leave later in the day.
Key facts
- Study ID
- NCT01851473
- Run by
- National Institute on Drug Abuse (NIDA)
- People needed
- 14
- Starts
- 2012-10-24
- Expected to finish
- 2015-10-07
- Last updated by the study team
- 2018-07-05
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- Current physical dependence on any drug other than cocaine, caffeine, or nicotine
- Current clinically significant medical or psychiatric disorder, such as heart disease, kidney disease, liver disease, adrenal insufficiency, myasthenia gravis, glucose-6-phosphate dehydrogenase deficiency, epilepsy, stroke, optic neuritis, hyperthyroidism, glaucoma; or psychosis, panic attacks, depression, or mania
- Current sulfa allergy
- Currently seeking treatment for a cocaine use disorder or in such treatment within the prior 3 months
- Current hypertension or blood pressure readings consistently above 140 mm Hg systolic or 90 mmHg diastolic while at rest
- Heart rate consistently above 90 bpm or below 50 bpm while at rest
- History of premature coronary artery disease or heart attack before age 50 in a first degree biological relative
- QTc greater than 450 ms or evidence of heart block, ischemia, or other clinically significant cardiovascular disease on a 12-lead resting ECG with three-minute rhythm strip
- Hemoglobin less than 12.5 g/dL
- Blood donation within 8 weeks of study entry
- History of clinically significant adverse reaction to ingestion of cocaine, acetazolamide, or quinine
- Hypersensitivity to acetazolamide, sulfonamides, sulfonamide derivatives, quinine, mefloquine or quinidine
- Women who are pregnant or nursing
- Currently on anti-hypertensive medication
Where it is running
- National Institute on Drug Abuse — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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