The Efficacy of Prazosin for Cocaine Users - Full Text View

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00880997

Purpose

Prazosin, an alpha 1-adrenergic receptor may play an important role in cocaine addiction in human. This study will evaluate the effectiveness of prazosin in preventing drug relapse among cocaine and opiate addicts.

Condition	Intervention	Phase
Cocaine Dependence Opioid Dependency	Drug: prazosin Drug: Placebo	Phase IV

Drug Information available for: Cocaine hydrochloride Prazosin Prazosin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Prazosin, An Alpha-1 Adrenergic Antagonist, for Cocaine Dependence in Methadone-Maintained Subjects: Pilot Study

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Self reports of cocaine and other drug use and cravings [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Prazosin will be well tolerated without significant side effects as we increased to our target dose of 10 mg prazosin daily [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	16
Study Start Date:	May 2009
Estimated Study Completion Date:	January 2012
Estimated Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
prazosin: Experimental The starting dose will be 2 mg once daily at clinic on day 1 and 2 at week 2 of the overall 17 week study, then 2 mg at clinic and 2 mg at home on day 3 to 6, then 4 mg at clinic and 2 mg at home on day 7-9, then 5 mg at clinic and 3 mg at home day 10-13, then 5 mg at clinic and 5 mg at home on day 14 to end of study.The target dose of 10 mg will probably not be attained by some patients over a 2 week induction period. We will try to increase their dose up to a minimum of 5 mg and optimum of 10 mg daily as twice daily dosing - one 5 mg dose in clinic with methadone and one 5 mg dose at home before sleeping.	Drug: prazosin The target dose of 10 mg will probably not be attained by some patients over a 2 week induction period (starting at week 2 of the overall 17 week study). We will try to increase their dose up to a minimum of 5 mg and optimum of 10 mg daily as twice daily dosing - one 5 mg dose in clinic with methadone and one 5 mg dose at home before sleeping.The starting dose will be 2 mg once daily at clinic on day 1 and 2, then 2 mg at clinic and 2 mg at home on day 3 to 6, then 4 mg at clinic and 2 mg at home on day 7-9, then 5 mg at clinic and 3 mg at home day 10-13, then 5 mg at clinic and 5 mg at home on day 14 to end of study.
placebo: Placebo Comparator	Drug: Placebo Placebo daily dosing

Arms

Assigned Interventions

prazosin: Experimental

The starting dose will be 2 mg once daily at clinic on day 1 and 2 at week 2 of the overall 17 week study, then 2 mg at clinic and 2 mg at home on day 3 to 6, then 4 mg at clinic and 2 mg at home on day 7-9, then 5 mg at clinic and 3 mg at home day 10-13, then 5 mg at clinic and 5 mg at home on day 14 to end of study.The target dose of 10 mg will probably not be attained by some patients over a 2 week induction period. We will try to increase their dose up to a minimum of 5 mg and optimum of 10 mg daily as twice daily dosing - one 5 mg dose in clinic with methadone and one 5 mg dose at home before sleeping.

Drug: prazosin

The target dose of 10 mg will probably not be attained by some patients over a 2 week induction period (starting at week 2 of the overall 17 week study). We will try to increase their dose up to a minimum of 5 mg and optimum of 10 mg daily as twice daily dosing - one 5 mg dose in clinic with methadone and one 5 mg dose at home before sleeping.The starting dose will be 2 mg once daily at clinic on day 1 and 2, then 2 mg at clinic and 2 mg at home on day 3 to 6, then 4 mg at clinic and 2 mg at home on day 7-9, then 5 mg at clinic and 3 mg at home day 10-13, then 5 mg at clinic and 5 mg at home on day 14 to end of study.

placebo: Placebo Comparator

Drug: Placebo

Placebo daily dosing

Detailed Description:

The NE system, especially the alpha 1-adrenergic receptor may play an important role in cocaine addiction in human. 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 10 mg Prazosin daily and will guide future pharmacotherapy trials using prazosin or related alpha 1 receptor antagonists for cocaine addiction.

This 17-week double-blind, placebo controlled clinical trial will provide treatment for 16 cocaine-dependent opioid dependent patients and includes a 2-week methadone stabilization and an 12-week medication trial (weeks 2-13). At the end of this period subjects will have a 4-week methadone detoxification (weeks 14-17) and a concurrent 2-week study medication taper (weeks 14-15). Qualifying subjects will be randomized to receive prazosin 10 mg/day, or placebo while concurrently receiving treatment with methadone.

During the first two weeks of the study, subjects will be inducted onto methadone and they will receive placebo study medication capsules for week 1. At the beginning of week 2, participants receive methadone plus prazosin, or placebo 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 detoxification from methadone and discontinuation from active/placebo medication over a 4-week and 2-week period respectively. Subjects who wish to be transferred to an appropriate opioid treatment program or treatment-research program will be held up to 4 weeks (i.e., weeks 14-17).

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Meets DSM-IV diagnosis criteria for opioid dependence, as determined by documentation of prior treatment for addiction; signs of withdrawal; self-reported history of dependence for at least 1 year; and a positive urine test for opioids
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 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 opiates, 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
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

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

Contacts

Contact: Guiying G Wu, MD	713-791-1414 ext 6384	ggwu@bcm.edu
Contact: Xiang Y Zhang, MD,PhD	713-791-1414 ext 5824	xyzhang@bcm.edu

Locations

United States, Texas
Michael E. DeBakey VA Medical Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Thomas R Kosten, MD

Baylor College of Medicine

More Information

No publications provided

Responsible Party:	Baylor College of Medicine ( Thomas Kosten, MD )
Study ID Numbers:	NIDA-18197-4, P50-DA18197-04
Study First Received:	April 13, 2009
Last Updated:	April 13, 2009
ClinicalTrials.gov Identifier:	NCT00880997 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):

Cocaine Dependence
Opioid Dependency
Substance Related Disorders

Study placed in the following topic categories:

Dopamine Uptake Inhibitors
Cocaine-Related Disorders
Neurotransmitter Agents
Adrenergic Agents
Central Nervous System Depressants
Anesthetics
Disorders of Environmental Origin
Adrenergic alpha-Antagonists
Cardiovascular Agents
Antihypertensive Agents
Anesthetics, Local

Methadone
Dopamine
Mental Disorders
Prazosin
Substance-Related Disorders
Vasoconstrictor Agents
Adrenergic Antagonists
Dopamine Agents
Peripheral Nervous System Agents
Cocaine

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Physiological Effects of Drugs
Disorders of Environmental Origin
Anesthetics
Prazosin
Mental Disorders
Sensory System Agents
Therapeutic Uses
Vasoconstrictor Agents

Substance-Related Disorders
Cocaine
Cocaine-Related Disorders
Central Nervous System Depressants
Cardiovascular Agents
Adrenergic alpha-Antagonists
Antihypertensive Agents
Pharmacologic Actions
Anesthetics, Local
Dopamine Agents
Adrenergic Antagonists
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009