The Efficacy of Doxazosin for Cocaine Users

August 8, 2019 updated by: Thomas R. Kosten, MD, Baylor College of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Medication induction will occur at a rate of 2mg/week until 8mg/day target dose is achieved as follows:

  1. Dox-Fast Group: Defined as participants reaching the target dose after a 4-week titration period. Participants will be stabilized on doxazosin or placebo over weeks 4-13 (for Dox-Fast group)
  2. Dox-Slow Group: Defined as participants reaching the target dose after an 8-week titration period. Participants will be stabilized on doxazosin or placebo over weeks 8-13 (for Dox-Slow group)

Both groups will be tapered off doxazosin or placebo over study weeks 14-17.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine - Michael E. DeBakey VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Doxazosin

Medication induction occurred at a rate of 2mg/week until 8mg/day target dose was achieved as follows:

  1. Dox-Fast Group: Defined as participants reaching the target dose after a 4-week titration period. Participants were stabilized on doxazosin or placebo over weeks 4-13 (for Dox-Fast group)
  2. Dox-Slow Group: Defined as participants reaching the target dose after an 8-week titration period. Participants were stabilized on doxazosin or placebo over weeks 8-13 (for Dox-Slow group)

Both groups were tapered off doxazosin or placebo over study weeks 14-17.
Drug: Doxazosin

Medication induction occurred at a rate of 2mg/week until 8mg/day target dose was achieved as follows:

  1. Dox-Fast Group: Defined as participants reaching the target dose after a 4-week titration period. Participants were stabilized on doxazosin or placebo over weeks 4-13 (for Dox-Fast group)
  2. Dox-Slow Group: Defined as participants reaching the target dose after an 8-week titration period. Participants were stabilized on doxazosin or placebo over weeks 8-13 (for Dox-Slow group)

Both doxazosin groups will be tapered off doxazosin or placebo over study weeks 14-17.

Other Names:
  • Cardura (Doxazosin Mesylate)
PLACEBO_COMPARATOR: placebo
A sugar pill to mimic the experiment drug, doxazosin, will be administered in the same manner as the experimental drug through the study duration.
Other: Placebo
Participants will be administered a sugar pill to mimic the doxazosin active medication with administration being the same as the active medication.
Other Names:
  • sugarpills ( Capsules)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cocaine Negative Urines
Time Frame: throughout the study - up to 17 weeks
cocaine urine toxicology samples were obtained thrice weekly and tested for the presence of the cocaine metabolite, benzoylecgonine
throughout the study - up to 17 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weeks of Abstinence
Time Frame: throughout the study - up to 17 weeks
Percentage of participants achieving 2 or more consecutive weeks of abstinence
throughout the study - up to 17 weeks
# of Participants That Completed the Study
Time Frame: throughout the study - up to 17 weeks
Retention
throughout the study - up to 17 weeks
Adverse Events
Time Frame: throughout study - upto 17 weeks
throughout study - upto 17 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Collaborators

National Institute on Drug Abuse (NIDA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

April 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

April 13, 2009

First Submitted That Met QC Criteria

April 13, 2009

First Posted (ESTIMATE)

April 14, 2009

Study Record Updates

Last Update Posted (ACTUAL)

August 22, 2019

Last Update Submitted That Met QC Criteria

August 8, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-18197-4
  • DPMC (Other Identifier: NIDA)
  • P50DA018197-04 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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