A Pilot Study of Candesartan as a Treatment for Cocaine Dependence
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|ClinicalTrials.gov Identifier: NCT01938664|
Recruitment Status : Completed
First Posted : September 10, 2013
Last Update Posted : September 11, 2018
|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 :||41 participants|
|Intervention Model:||Single Group 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 wk 1-4. 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
- Urine toxicology for cocaine [ Time Frame: thrice weekly, baseline thru week 8 ]
- Retention [ Time Frame: 8 weeks ]
- Adverse Events [ Time Frame: 8 weeks ]Candesartan will be well tolerated without significant side effects.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|