The Efficacy of Doxazosin for Cocaine Users

NCT00880997 | Completed Phase 1 Results DMC

• 3 other identifiers: NIDA-18197-4P50DA018197-04DPMC
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Cocaine Dependence

Keywords

Cocaine Dependence; Substance Related Disorders

Outcome Measures

Primary Outcomes (1)

• Cocaine Negative Urines

  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 Outcomes (3)

• Weeks of Abstinence

  throughout the study - up to 17 weeks

• # of Participants That Completed the Study

  throughout the study - up to 17 weeks

• Adverse Events

  throughout study - upto 17 weeks

Study Arms (2)

Doxazosin

EXPERIMENTAL

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

placebo

PLACEBO COMPARATOR

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

Interventions

Doxazosin 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.

Also known as: Cardura (Doxazosin Mesylate)

Doxazosin

Placebo OTHER

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

Also known as: sugarpills ( Capsules)

placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

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

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders; Substance-Related Disorders

Interventions

Doxazosin

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Prazosin; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Initially the study randomized subjects into 2 conditions (placebo/DOX). After the observation that rapid titration was safe, a DOX-fast group was created. This did not allow for early participants to be randomized to the rapid titration condition.

Results Point of Contact

• Title: Thomas Kosten, MD
• Organization: Baylor College of Medicine

kosten@bcm.edu

713-794-7032

Study Officials

• Thomas R Kosten, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 13, 2009
• First Posted: April 14, 2009
• Study Start: September 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 22, 2019
• Results First Posted: August 22, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)