The Efficacy of Doxazosin for Cocaine Users
Information source: Baylor College of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cocaine Dependence
Intervention: Doxazosin (Drug); Placebo (Drug)
Phase: Phase 1
Sponsored by: Baylor College of Medicine
Official(s) and/or principal investigator(s):
Thomas R Kosten, MD, Principal Investigator, Affiliation: Baylor College of Medicine
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.
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
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
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.
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: 64 Years.
- 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
- Meets DSM-IV diagnosis criteria for dependence on any drugs other than cocaine, or
- 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
Locations and Contacts
Baylor College of Medicine - Michael E. DeBakey VA Medical Center, Houston, Texas 77030, United States
Starting date: September 2009
Last updated: October 22, 2012