NCT01062945

The Effects of Doxazosin on the Cardiovascular and Subjective Effects of Cocaine

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to asses the potential interactions between intravenous cocaine and doxazosin in cocaine dependent volunteers who are not seeking treatment. The study will evaluate the effects of doxazosin on the cardiovascular and subjective effects of cocaine in a human laboratory study.

Detailed description

Primary Objective: The primary objective is to determine the safety of treatment with doxazosin in cocaine-dependent volunteers by examining hemodynamic and subjective effects of administration of ascending doses of cocaine (0, 20mg, and 40mg) and a placebo dose during treatment with doxazosin. Secondary Objectives: To evaluate the effect of doxazosin on the pharmacokinetics of intravenously administered cocaine; To determine effects of treatment with doxazosin, as compared to placebo, on subjective effects produced by administration of cocaine or placebo.

Conditions

• Cocaine Addiction
• Cocaine Abuse
• Cocaine Dependence
• Substance Abuse

Interventions

Type	Name	Description
DRUG	Placebo	Matching administration of a placebo pill.
DRUG	Doxazosin	The dose of doxazosin needed to alter the effects of cocaine is unknown and preclinical animal studies have not been conducted. Because of this, initially we will study the effects of a low dose of doxazosin (4 mg daily) compared to placebo daily. Because this class of medication needs to be titrated upward due to the potential for hypotension, treatment will begin at 1 mg and increased by 1 mg increments every three days until 4 mg is reached on day 12.

Timeline

• Start date: 2010-01-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2010-02-04
• Last updated: 2012-07-27

Locations

1 site across 1 country: United States