Pharmacogenetics of Doxazosin for Cocaine Dependence
H-26605: Pharmacogenetics of Doxazosin for Cocaine Dependence
3 other identifiers
interventional
96
1 country
1
Brief Summary
Doxazosin, an alpha 1-adrenergic receptor antagonist, may play an important role in cocaine addiction in humans. This study will evaluate to what extent the prospective screening for catecholamine related polymorphisms for alpha 1 NE receptor/transporter, COMT and DBH as main targets predict the treatment efficacy of doxazosin for cocaine-using behavior.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2010
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 15, 2010
CompletedFirst Posted
Study publicly available on registry
June 16, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedResults Posted
Study results publicly available
July 22, 2019
CompletedJuly 22, 2019
July 1, 2019
5.5 years
June 15, 2010
September 20, 2018
July 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Cocaine Positive Urine Toxicology
Cocaine positive urines
2 weeks blocks throughout study
Secondary Outcomes (1)
Adverse Events
Pre- and post study medication
Study Arms (2)
Doxazosin
EXPERIMENTALDoxazosin is a long-acting and selective alpha 1-NE blocker, which inhibits the binding of norepinephrine to alpha receptors in the autonomic nervous system.
Placebo
PLACEBO COMPARATORMatched placebo daily dosing.
Interventions
Doxazosin is initiated at 4 mg/wk, and titrated up to a maximum of 8 mg/day over approximately 2 weeks. Participants will be maintained on 6mg-8mg daily dosing until week 13. The subjects will undergo the discontinuation from the study medication during weeks 14 -15.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Baylor College of Medicine
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Thomas Kosten, MD
- Organization
- Baylor College of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas R. Kosten, MD
Baylor College of Medicine
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Waggoner Chair and Professor of Psychiatry, Neuroscience, Pharmacology, Immunology and Pathology
Study Record Dates
First Submitted
June 15, 2010
First Posted
June 16, 2010
Study Start
March 1, 2010
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
July 22, 2019
Results First Posted
July 22, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share