The Efficacy of Doxazosin for Cocaine Users

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Thomas R. Kosten, MD, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00880997
First received: April 13, 2009
Last updated: October 22, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Cocaine Dependence
Drug: Doxazosin
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Doxazosin, An Alpha-1 Adrenergic Antagonist, for Cocaine Dependence: Pilot Study

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Self reports of cocaine and other drug use and cravings [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • The urine drug screen results [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Doxazosin will be well tolerated without significant side effects as we increased to our target dose of 8 mg Doxazosin daily [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]

Enrollment: 35
Study Start Date: September 2009
Study Completion Date: December 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Doxazosin
The starting dose will be 1 mg once daily at week 1 of the overall 17 week study, then 2 mg at week 2, with 1mg/week induction rate for 8 weeks. The target dose of 8 mg daily will probably not be attained by some patients over a 8 week induction period. We will try to increase their dose up to a minimum of 4 mg and optimum of 8 mg daily as daily dosing.
Drug: Doxazosin
The target dose of 8 mg will probably not be attained by some patients over a 8 week induction period (starting at week 1 of the overall 17 week study). We will try to increase the subjects' dose up to a minimum of 4 mg and optimum of 8 mg daily as once daily dosing. The starting dose will be 1 mg once daily at week 1, then 2 mg once daily at week 2, with 1mg/week induction rate for 8 weeks. They will be maintained on 4mg-8mg daily dosing until week 13. The subjects will be undergo the discontinuation from the study medication during weeks 14 -17.
Other Name: Cardura (Doxazosin Mesylate)
Placebo Comparator: placebo Drug: Placebo
Placebo daily dosing
Other Name: sugarpills ( Capsules)

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 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).

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00880997

Locations
United States, Texas
Baylor College of Medicine - Michael E. DeBakey VA Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Thomas R Kosten, MD Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Thomas R. Kosten, MD, Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00880997     History of Changes
Other Study ID Numbers: NIDA-18197-4, P50DA018197-04, DPMC
Study First Received: April 13, 2009
Last Updated: October 22, 2012
Health Authority: United States: Federal Government

Keywords provided by Baylor College of Medicine:
Cocaine Dependence
Substance Related Disorders

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Mental Disorders
Cocaine
Doxazosin
Adrenergic Antagonists
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Antihypertensive Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Agents

ClinicalTrials.gov processed this record on July 24, 2014