Clinical trial NCT00880997: The Efficacy of Doxazosin for Cocaine Users
Official title: Doxazosin, An Alpha-1 Adrenergic Antagonist, for Cocaine Dependence: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cocaine Dependence
Keywords: Cocaine Dependence
Substance Related Disorders
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2009-04-14
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cocaine Negative Urines
timeFrame: throughout the study - up to 17 weeks
Secondary outcomes:
measure: Weeks of Abstinence
timeFrame: throughout the study - up to 17 weeks
measure: # of Participants That Completed the Study
timeFrame: throughout the study - up to 17 weeks
measure: Adverse Events
timeFrame: throughout study - upto 17 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine - Michael E. DeBakey VA Medical Center
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Thomas R Kosten, MD
role: PRINCIPAL_INVESTIGATOR
References: