Status:
COMPLETED
Interactions Between Intravenous Cocaine and Acetazolamide or Quinine
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Conditions:
Cocaine Use
Pharmacokinetics
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
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 medica...
Detailed Description
Background: Cocaine dependence is a public health concern worldwide, with no FDA-approved pharmacological treatment for this condition. Thus, there is a need for controlled clinical trials to evaluate...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- Age 18-50 years old
- Smoked or used IV cocaine for at least six months and at least three times per month during the three months prior to screening. Urine test positive for cocaine within the prior 6 months
- Adequate venous access for catheter placement
- Serum sodium and potassium concentrations within normal limits (based on Johns Hopkins Bayview Medical Center clinical laboratory)
- Women with reproductive potential must use a medically acceptable form of contraception for the duration of the study. Medically acceptable forms of contraception include: oral contraceptive, intrauterine device (IUD), depot hormonal preparation (ring, injection implant), or a barrier method of contraception such as a diaphragm, sponge with spermicide, or a condom.
- EXCLUSION CRITERIA
- 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
Exclusion
Key Trial Info
Start Date :
October 24 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 7 2015
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01851473
Start Date
October 24 2012
End Date
October 7 2015
Last Update
July 5 2018
Active Locations (1)
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1
National Institute on Drug Abuse
Baltimore, Maryland, United States, 21224