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Pharmacogenetics of Doxazosin for Cocaine Dependence

Information source: Baylor College of Medicine
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cocaine Dependence

Intervention: Doxazosin (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Baylor College of Medicine

Official(s) and/or principal investigator(s):
Thomas R. Kosten, MD, Principal Investigator, Affiliation: Baylor College of Medicine

Overall contact:
Coreen Domingo, DrPH, Phone: 713-791-1414, Ext: 5054, Email: Coreen.Domingo@va.gov

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.

Clinical Details

Official title: H-26605: Pharmacogenetics of Doxazosin for Cocaine Dependence

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Primary outcome: The urine drug screen results and self reports of cocaine and other drug use and cravings

Secondary outcome: Adverse events reports

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 will provide treatment for 100 cocaine-dependent patients and 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.

Subjects will be receiving 1 mg study medication/placebo capsules at week 1, with 2mg/week induction rate for 3 weeks, according to their randomized assignments, and are maintained on these agents through week 13. At the end of the study (weeks 14-17), participants will undergo discontinuation from active/placebo medication over a 4-week period. Subjects who wish to be transferred to an appropriate treatment program or treatment-research program will be helped with referral during the 4 week period (weeks 14-17).

Eligibility

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: (1) Signed informed consent form (2) Subject understands the risk and benefits and agrees to visit frequency and procedures (3) Male or female (4) Any race or ethnic origin (5)Diagnosis of cocaine-dependence according to DSM-IV criteria (6) between the ages of 18 and 64 (7)Must be current users of cocaine with self-reported use of cocaine at least once weekly for at least one month preceding study entry, cocaine-positive urine screen and score over 3 which is the cut-off for diagnosis of cocaine dependence as assessed with the Severity of Dependence Scale (Kaye & Darke 2002; Gossop, et al 1995; Gossop, et al. 1997) (8)Women of childbearing age are eligible to be included in the study if they have a negative pregnancy test at screening, agree to adequate contraception to prevent pregnancy, to have monthly pregnancy tests, and they understand the risk of fetal toxicity due to medication.

Exclusion Criteria: (1)Current diagnosis of other drug , especially alcohol or benzodiazepine dependence or abuse (other than cocaine or tobacco) (2) Significant medical conditions (e. g., major cardiovascular, renal, endocrine, hepatic disorders) such as abnormal liver function (with laboratory findings of SGOT or SGPT greater than three times normal), hypotension or hypertension, a current cardiac condition, and those having a high risk of cardiovascular disease, seizure disorders, or another significant underlying medical condition which would contraindicate Doxazosin treatment (3)Lifetime schizophrenia, bipolar disorder, or other psychotic disorders (4) Actively considering plans of suicidality or homicidality (5) Current use of a prescribed psychotropic medication that cannot be discontinued (6) Women planning to become pregnant or breastfeed during the study, or refuse to use a reliable form of birth control or refuse monthly pregnancy testing (7) Subjects who are prescribed any anti-hypertension drugs including Viagra, except thiazides, will be excluded because these medications may interact with Doxazosin's brain effects in reducing cocaine abuse.

Locations and Contacts

Coreen Domingo, DrPH, Phone: 713-791-1414, Ext: 5054, Email: Coreen.Domingo@va.gov

Baylor College of Medicine, Houston, Texas 77030, United States; Recruiting
Coreen B Domingo, DPH, Phone: 713-791-1414, Ext: 5054, Email: cdomingo@bcm.edu
Katrina E. Campodonico, M.Ed, Phone: 713-791-1414, Ext: 6381, Email: katrina.campodonico@va.gov
Coreen B Domingo, DPH, Sub-Investigator
Thomas R Kosten, MD, Principal Investigator
Daryl Shorter, MD, Sub-Investigator
Additional Information

Starting date: March 2010
Last updated: February 4, 2013

Page last updated: February 07, 2013

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