Study to Improve Scientific Understanding of the Cardiovascular Actions of Cocaine

Cocaine and Sympathetic Nerve Activity in Humans

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00338546

Enrollment

Registered

2006-06-20

Start date

Unknown

Completion date

Unknown

Last updated

2019-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cocaine Induced Sympathoexciation and Vasoconstriction

Keywords

Cocaine, Sympathetic nerve activity, Blood pressure, Cutaneous vasoconstriction, Coronary vasoconstriction

Brief summary

The purpose of this study is to improve the scientific understanding of the cardiovascular actions of cocaine, in particular the ability of cocaine to increase blood pressure.

Detailed description

Cocaine abuse has emerged as a major cause of life-threatening cardiovascular emergencies but our understanding of the underlying mechanisms mediating the adverse effects of cocaine is far from complete. Our previous studies in cocaine-naive human subjects have demonstrated that intranasal cocaine acutely stimulates the human cardiovascular system by a novel central mechanism of action.We are currently investigating a central sympatholytic drug,dexmedetomidine, in reversing the sympathomimetic effects (increase in blood pressure, heart rate and coronary vasoconstriction) of intranasal cocaine.This drug may be a new pharmacologic agent in the treatment of acute cocaine intoxication in humans.

Interventions

DRUGCocaine hydrochloride

DRUGDexmedetomidine

PROCEDUREMicroneurography

PROCEDURELaser doppler velocimetry

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Cocaine naive healthy volunteers

Exclusion criteria

* Any evidence of cardiopulmonary disease by history or physical examination * History of hypertension or 24 hour blood pressure averaging \>135/85 mmHg * Any history of substance abuse (other than tobacco) * Diabetes mellitus or other systemic illness * Individuals with a history of pseudocholinesterase deficiency * Pregnancy

Design outcomes

Primary

Measure	Time frame
Blood pressure	—
Heart rate	—
Skin sympathetic nerve activity	—
Skin blood flow	—
Coronary blood flow	—

Secondary

Measure	Time frame
Sedation status	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026