The Efficacy of Doxazosin for Cocaine Users

Cocaine Dependence Clinical Trial

Official title:

Doxazosin, An Alpha-1 Adrenergic Antagonist, for Cocaine Dependence: Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00880997
• Other study ID #: NIDA-18197-4
• Secondary ID: P50DA018197-04DP
• Status: Completed
• Phase: Phase 1
• Start date: September 2009
• Est. completion date: December 2011

Study information

• Verified date: August 2019
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Cocaine Dependence
• Cocaine-Related Disorders

Intervention

Drug:
• Doxazosin
Medication induction occurred at a rate of 2mg/week until 8mg/day target dose was achieved as follows: 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) 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.

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

Locations

Country	Name	City	State
United States	Baylor College of Medicine - Michael E. DeBakey VA Medical Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cocaine Negative Urines	cocaine urine toxicology samples were obtained thrice weekly and tested for the presence of the cocaine metabolite, benzoylecgonine	throughout the study - up to 17 weeks
Secondary	Weeks of Abstinence	Percentage of participants achieving 2 or more consecutive weeks of abstinence	throughout the study - up to 17 weeks
Secondary	# of Participants That Completed the Study	Retention	throughout the study - up to 17 weeks
Secondary	Adverse Events		throughout study - upto 17 weeks