Interactions Between Intravenous Cocaine and Acetazolamide or Quinine

• Status: Completed
• Trial end date: 2015-10-07
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute on Drug Abuse (NIDA)
• Treatments: Acetazolamide; Cocaine; Quinine

Criteria

• 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