NCT01851473

Interactions Between Intravenous Cocaine and Acetazolamide or Quinine

Completed Phase 1 Last updated 5 July 2018

What this trial tests

Phase 1 trial testing cocaine in Cocaine Use in 14 participants. Completed in 7 October 2015.

Timeline

24 October 2012

Primary endpoint
7 October 2015

7 October 2015

Quick facts

Lead sponsor	National Institute on Drug Abuse (NIDA)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	crossover
Masking	none
Primary purpose	diagnostic
Enrollment	14
Start date	24 October 2012
Primary completion	7 October 2015
Estimated completion	7 October 2015
Sites	1 location across United States

Drugs / interventions tested

• cocaine (COCAINE) — full drug profile →
• quinine (QUININE) — full drug profile →
• acetazolamide (ACETAZOLAMIDE) — full drug profile →

Conditions studied

• Cocaine Use — all drugs for Cocaine Use →
• Pharmacokinetics — all drugs for Pharmacokinetics →

Sponsor

National Institute on Drug Abuse (NIDA)

Who can join

Adults 18 to 50, any sex, with Cocaine Use or Pharmacokinetics. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Acute effects of intravenous cocaine administration on serum concentrations of ghrelin, amylin, glucagon-like peptide-1, insulin, leptin and peptide YY and relationships with cardiorespiratory and subjective responses.
   Bouhlal S, Ellefsen KN, Sheskier MB, Singley E, et al · · 2017 · cited 35× · PMID 28881319 · DOI 10.1016/j.drugalcdep.2017.07.033
2. Subtherapeutic Acetazolamide Doses as a Noninvasive Method for Assessing Medication Adherence.
   Hampson AJ, Schroeder JR, Ellefsen KN, Yammine L, et al · · 2020 · cited 3× · PMID 32496573 · DOI 10.1002/cpt.1929