CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 43 enrolled
Drug / intervention
Doxazosin +1 moredrug
Likely dose
Doxazosin 2 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01953432
NCT01953432Phase 2Completed

Pharmacogenetic Trial of Noradrenergic Medication for Treatment of Cocaine Abuse

VA Office of Research and Development·interventional·Posted Oct 1, 2013·Updated Feb 20, 2020

In Brief

A Phase 2 clinical trial evaluating Doxazosin and Placebo for Cocaine Dependence. Completed, enrolled 43 participants across 1 site.

Detailed Summary

Cocaine use disorders affect approximately 1.5 million Americans annually. Currently, there are no US Food and Drug Administration approved medications for treatment of cocaine dependence; however, both animal and human studies suggest that medications affecting the noradrenergic system can reduce cocaine craving and use. The investigators will study the effect of doxazosin, an alpha-1 adrenergic antagonist, in reducing cocaine use and anxiety symptoms among cocaine-dependent individuals. In addition, the investigators will identify genetic subpopulations of participants who preferentially respond to the medication.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 1, 2013
Enrollment StartApr 1, 2014
Primary CompletionSep 1, 2017
Study CompletionOct 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 12.8 years ago

Interventions

Doxazosindrug

Doxazosin is initiated at 2 mg/wk, and titrated up to a maximum of 8 mg/day over approximately 4 weeks. Participants will be maintained on 8mg daily dosing until week 13. The subjects will undergo the discontinuation from the study medication during weeks 14 -15.

Placebodrug

Matched placebo daily dosing