The Efficacy of Doxazosin for Cocaine Users

Baylor College of Medicine35 enrolled

Overview

Doxazosin, an alpha 1-adrenergic receptor, may play an important role in cocaine addiction in humans. This study will evaluate the effectiveness of doxazosin in preventing drug relapse among cocaine dependent participants.

The NE system, especially the alpha 1-adrenergic receptor, may play an important role in cocaine addiction in humans. The results of this study will provide medical safety data on the duration of the induction schedule that will be optimal for attaining our target dose of 8 mg doxazosin daily and will guide future pharmacotherapy trials using Doxazosin or related alpha 1 receptor antagonists for cocaine addiction. This 17-week double-blind, placebo controlled clinical trial includes a 13 week medication trial (weeks 1-13) and up to 4 week washout period(weeks 14-17). Qualifying subjects will be randomized to receive Doxazosin 8 mg/day, or placebo during the study participation. Medication induction will occur at a rate of 2mg/week until 8mg/day target dose is achieved as follows: 1. Dox-Fast Group: Defined as participants reaching the target dose after a 4-week titration period. Participants will be stabilized on doxazosin or placebo over weeks 4-13 (for Dox-Fast group) 2. Dox-Slow Group: Defined as participants reaching the target dose after an 8-week titration period. Participants will be stabilized on doxazosin or placebo over weeks 8-13 (for Dox-Slow group) Both groups will be tapered off doxazosin or placebo over study weeks 14-17.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Cocaine Dependence

Interventions

DoxazosinDRUG

Medication induction occurred at a rate of 2mg/week until 8mg/day target dose was achieved as follows: 1. Dox-Fast Group: Defined as participants reaching the target dose after a 4-week titration period. Participants were stabilized on doxazosin or placebo over weeks 4-13 (for Dox-Fast group) 2. Dox-Slow Group: Defined as participants reaching the target dose after an 8-week titration period. Participants were stabilized on doxazosin or placebo over weeks 8-13 (for Dox-Slow group) Both doxazosin groups will be tapered off doxazosin or placebo over study weeks 14-17.

PlaceboOTHER

Participants will be administered a sugar pill to mimic the doxazosin active medication with administration being the same as the active medication.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Meets DSM-IV diagnosis criteria for cocaine dependence, as determined by self-reported use of cocaine at least once weekly for at least 1 month prior to study entry; a positive urine test for cocaine; and a score greater than 3 on the Severity of Dependence Scale * If female, willing to use contraception throughout the study Exclusion Criteria: * Meets DSM-IV diagnosis criteria for dependence on any drugs other than cocaine, or tobacco * Current major psychiatric illness, including schizophrenia, bipolar disorder, or other psychotic disorder * Current suicidal or homicidal ideation * Current use of a prescribed psychotropic medication that cannot be discontinued * History of or current major medical illness, including major heart, kidney, endocrine, or liver disorder; abnormal liver function (SGOT or SGPT levels three times greater than normal); or high blood pressure or low blood pressure * High risk factor for heart disease, seizure disorders, or any illness for which disulfiram or methadone treatment would be inadvisable * Currently taking metronidazole or clotrimazole * Pregnant or breastfeeding

Locations (1)

Baylor College of Medicine - Michael E. DeBakey VA Medical Center

Houston, Texas, United States

Outcomes

Primary Outcomes

Cocaine Negative Urines

cocaine urine toxicology samples were obtained thrice weekly and tested for the presence of the cocaine metabolite, benzoylecgonine

Time frame: throughout the study - up to 17 weeks

Secondary Outcomes

Weeks of Abstinence

Percentage of participants achieving 2 or more consecutive weeks of abstinence

Time frame: throughout the study - up to 17 weeks

# of Participants That Completed the Study

Retention

Time frame: throughout the study - up to 17 weeks

Adverse Events

Time frame: throughout study - upto 17 weeks

Data from ClinicalTrials.gov

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