A Pilot Study of Candesartan as a Treatment for Cocaine Dependence
|ClinicalTrials.gov Identifier: NCT01938664|
Recruitment Status : Terminated (Results of interim efficacy analysis showed results were not promising.)
First Posted : September 10, 2013
Results First Posted : August 26, 2019
Last Update Posted : September 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cocaine Dependence||Drug: Candesartan with CBT Other: Placebo with CBT||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Pilot Study of Candesartan: An Angiotensin Receptor Blocker as a Treatment for Cocaine Dependence|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||July 2016|
Experimental: Candesartan w Cognitive Behavior Therapy
Titration up to 8mg through week 1. Continue on 8mg thru wk 8. CBT optional thru study.
Drug: Candesartan with CBT
8 mg, po (by mouth)
Other Name: atacand
Placebo Comparator: Placebo w Cognitive Behavior Therapy
Sugar pill to mimic Candesartan for study duration. CBT optional thru study.
Other: Placebo with CBT
- # of Participants With Presence of Cocaine Metabolites Via Urinalysis [ Time Frame: thrice weekly, baseline thru week 8 ]
- # of Participants Retained in Study [ Time Frame: 8 weeks ]
- # of Participants With Adverse Events [ Time Frame: 8 weeks ]Candesartan will be well tolerated without significant side effects.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01938664
|United States, Texas|
|Michael E. DeBakey VA Medical Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Thomas Kosten, MD||Baylor College of Medicine|