The Effects of Doxazosin on the Cardiovascular and Subjective Effects of Cocaine
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|ClinicalTrials.gov Identifier: NCT01062945|
Recruitment Status : Completed
First Posted : February 4, 2010
Last Update Posted : July 27, 2012
|Condition or disease||Intervention/treatment||Phase|
|Cocaine Addiction Cocaine Abuse Cocaine Dependence Substance Abuse||Drug: Placebo Drug: Doxazosin||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effects of Doxazosin on the Cardiovascular and Subjective Effects of Cocaine|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||January 2011|
|Placebo Comparator: Placebo||
Matching administration of a placebo pill.
Other Name: Sugar pill
|Active Comparator: 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.
Other Name: Cardura
- The effects of treatment with doxazosin on cardiovascular effects after administration of ascending doses of cocaine (0, 20mg, and 40mg) and a placebo dose.Blood pressure (resting and orthostatic) will be assessed daily prior to dosing. Heart rate, EKG, and blood pressure will be recorded throughout and after experimental sessions using an automatic monitoring system. Participants will be monitored for stability on days 11 and 12 and discharged from the hospital on day 13.
- The effects of treatment with doxazosin, as compared to placebo, on subjective measures produced by administration of cocaine or placebo.Visual-analogue scale ratings of "any cocaine effect", "high", "good effects", "bad effects", "like cocaine", "desire cocaine", "depressed", "anxious", "stimulated", and "if you had access to cocaine right now, how likely would you be to use it?" will be collected at -15 min, 5 min, 10 min, 15 min, 20 min, 30 min, and 45 min after cocaine dosing.
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): NCT01062945
|United States, Texas|
|Michael Debakey VA Medical Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Thomas Newton, MD||Baylor College of Medicine|