The Efficacy of Doxazosin for Cocaine Users

Condition(s) targeted: Cocaine Dependence

Intervention: Doxazosin (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: National Institute on Drug Abuse (NIDA)

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

Overall contact:
Guiying G Wu, MD, Phone: 713-791-1414, Ext: 4522, Email: ggwu@bcm.edu

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

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

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

Primary outcome:

Self reports of cocaine and other drug use and cravings

The urine drug screen results

Secondary outcome: Doxazosin will be well tolerated without significant side effects as we increased to our target dose of 8 mg Doxazosin daily

Detailed description: The NE system, especially the alpha 1-adrenergic receptor may play an important role in cocaine addiction in human. 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 16 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 1mg/week induction rate for 8 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).

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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 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

- 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

Guiying G Wu, MD, Phone: 713-791-1414, Ext: 4522, Email: ggwu@bcm.edu

Baylor College of Medicine - Michael E. DeBakey VA Medical Center, Houston, Texas 77030, United States; Recruiting
Thomas Kosten, MD, Phone: 713-794-7032, Email: kosten@bcm.edu
guiying wu, MD, Phone: 713-791-1414, Ext: 5824, Email: ggwu@bcm.edu
Thomas Kosten, MD, Principal Investigator
Xiang Zhang, MD, Sub-Investigator

Starting date: September 2009
Last updated: August 27, 2010