The Effects of Doxazosin on the Cardiovascular and Subjective Effects of Cocaine
The purpose of the study is to asses the potential interactions between intravenous cocaine and doxazosin in cocaine dependent volunteers who are not seeking treatment. The study will evaluate the effects of doxazosin on the cardiovascular and subjective effects of cocaine in a human laboratory study.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
|Official Title:||The Effects of Doxazosin on the Cardiovascular and Subjective Effects of Cocaine|
- The effects of treatment with doxazosin on cardiovascular effects after administration of ascending doses of cocaine (0, 20mg, and 40mg) and a placebo dose. [ Designated as safety issue: Yes ]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. [ Designated as safety issue: No ]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.
|Study Start Date:||January 2010|
|Study Completion Date:||January 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
|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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01062945
|United States, Texas|
|Michael Debakey VA Medical Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Thomas Newton, MD||Baylor College of Medicine|