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NCT01851473 · ClinicalTrials.gov registry record · Phase 1

Interactions Between Intravenous Cocaine and Acetazolamide or Quinine

A Phase 1 study, sponsored by National Institute on Drug Abuse (NIDA).

Completed
Registry status
Phase 1
Development phase
14
Enrollment target

NCT01851473: Completed Phase 1 study, sponsored by National Institute on Drug Abuse (NIDA).

NCT01851473 is a Phase 1 study that has completed, run by National Institute on Drug Abuse (NIDA). The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01851473, a Phase 1 study, has completed, sponsored by National Institute on Drug Abuse (NIDA).

COMPLETED
Registry status
Phase 1
Development phase
14 participants
Enrollment target

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.

Interventions

  • DRUG cocaine
  • DRUG quinine
  • DRUG acetazolamide

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2012-10-24
Est. Completion 2015-10-07
Phase Phase 1

What the finished NCT01851473 record still lists

NCT01851473 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).

The record links to 0 conditions, and to 3 interventions - of which cocaine is the first listed.

NCT01851473 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01851473 about?

NCT01851473 is a clinical study titled "Interactions Between Intravenous Cocaine and Acetazolamide or Quinine". 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 whe...

What is the current status of trial NCT01851473?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2012-10-24. Estimated completion is 2015-10-07.

What interventions are being tested in trial NCT01851473?

The interventions under investigation include: cocaine (DRUG), quinine (DRUG), acetazolamide (DRUG).

Who is sponsoring clinical trial NCT01851473?

This trial is sponsored by National Institute on Drug Abuse (NIDA), which has 335 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01851473's enrollment target sits among peer trials

14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01851473, the US trial registry maintained by the National Library of Medicine. NCT01851473 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.