The Efficacy of Doxazosin for Cocaine Users

NCT ID: NCT00880997

Last Updated: 2019-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2011-12-31

Brief Summary

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.

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.

Conditions

Cocaine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Doxazosin

Intervention Type: DRUG

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.

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Participants will be administered a sugar pill to mimic the doxazosin active medication with administration being the same as the active medication.

Interventions

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.

Intervention Type: DRUG

Placebo

Participants will be administered a sugar pill to mimic the doxazosin active medication with administration being the same as the active medication.

Intervention Type: OTHER

Other Intervention Names

Cardura (Doxazosin Mesylate); sugarpills ( Capsules)

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Thomas R. Kosten, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas R Kosten, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Baylor College of Medicine - Michael E. DeBakey VA Medical Center

Houston, Texas, United States

Countries

United States

Other Identifiers

P50DA018197-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DPMC

Identifier Type: OTHER

Identifier Source: secondary_id

NIDA-18197-4

Identifier Type: -

Identifier Source: org_study_id