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Interactions Between Intravenous Cocaine and Acetazolamide or Quinine

NCT01851473 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2018-07-05

No results posted yet for this study

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.

Conditions

  • Cocaine Use
  • Pharmacokinetics

Interventions

DRUG

cocaine

25 mg IV on days 1, 5, and 10

DRUG

quinine

80 mg orally on days 7-10

DRUG

acetazolamide

15 mg orally on days 2-5

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    lead NIH

Principal Investigators

  • Marilyn Huestis, Ph.D. · National Institute on Drug Abuse (NIDA)

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-10-24
Primary Completion
2015-10-07
Completion
2015-10-07

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01851473 on ClinicalTrials.gov