NCT01938664

A Pilot Study of Candesartan as a Treatment for Cocaine Dependence

Pilot Study of Candesartan: An Angiotensin Receptor Blocker as a Treatment for Cocaine Dependence

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see if a drug called Candesartan will help to reduce use of cocaine.

Detailed description

The noradrenergic system may play an important role in cocaine addiction in humans. Angiotensin II (Ang II) is known to enhance noradrenergic activity, which contributes to effects on blood pressure and sympathetic nervous system responses to stress. Inhibition of Ang II has been shown to reduce cravings for stimulants, including cocaine and methamphetamine. This clinical trial among 75 cocaine-dependent subjects is designed to test the efficacy of the Angiotensin II receptor antagonist, Candesartan, for treatment of cocaine dependence. The results of this study will provide medical safety and efficacy data, and will guide future pharmacotherapy trials using this class of medications for cocaine addiction. This 8-week trial includes a 1-week titration of the medication and 7-weeks of full dose medication (weeks 2-8), with all subjects receiving the active agent. At the conclusion of the trial, subjects who wish to be referred to an appropriate treatment program or treatment research program will be assisted with a referral.

Conditions

• Cocaine Dependence

Interventions

Type	Name	Description
DRUG	Candesartan with CBT	8 mg, po (by mouth)
OTHER	Placebo with CBT

Timeline

• Start date: 2013-01-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2013-09-10
• Last updated: 2019-09-04
• Results posted: 2019-08-26

Locations

1 site across 1 country: United States