Prazosin for ETOH or Cocaine Craving - Full Text View

Purpose

This double-blind placebo controlled crossover pilot trial will test the hypothesis that prazosin, an alpha-1 adrenergic receptor antagonist, reduces craving for their drug of choice in cocaine-dependent and alcohol-dependent veterans. Both the study medication period and the placebo period are each 4 weeks in duration.

Condition	Intervention
Alcoholism Cocaine Dependence	Drug: Prazosin

MedlinePlus related topics:

Alcoholism

ChemIDplus related topics:

8-Azabicyclo(3.2.1)octane-2-carboxylic acid, 3-(benzoyloxy)-8-methyl-, methyl ester, (1R-(exo,exo))- Cocaine hydrochloride Ethanol Prazosin Prazosin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study

Official Title:	The Role of the Alpha 1-Adrenergic Antagonist, Prazosin, in the Reduction of Craving and Relapse in Alcohol and Cocaine-Dependent Individuals: a Double-Blind, Randomized, Controlled Clinical Trial

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

Change in skin conductance response in response to provocative visual cues designed to elicit craving, compared to placebo group [ Time Frame: During lab session ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in heart rate response in response to provocative visual cues designed to elicit craving, compared to placebo group [ Time Frame: During lab session ] [ Designated as safety issue: No ]
Change in blood pressure response in response to provocative visual cues designed ot elicit craving, compared to placebo group [ Time Frame: During lab session ] [ Designated as safety issue: No ]
Change in subjective experience of craving in response to provocative visual cues designed to elicit craving, as measured by the Within Session Rating for Cocaine/Alcohol Craving [ Time Frame: During lab session ] [ Designated as safety issue: No ]
Change in self-reports of substance use between study medication and placebo periods [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Change in urine drug analysis results between study medication and placebo periods [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	32
Study Start Date:	April 2004
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Prazosin vs. placebo	Drug: Prazosin FDA approved medication for hypertension

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 18-70 years
Current DSM-IV diagnosis of alcohol dependence or cocaine dependence with no use in last 30 days
Capacity to provide informed consent
Actively enrolled in chemical dependency treatment at VA Puget Sound English fluency

Exclusion Criteria:

Evidence of significant abuse of opiates, PCP, sedatives or anxiolytics
Suicidal ideation
DSM IV diagnosis of bipolar mood disorder, schizophrenia or schizoaffective disorder
Significant acute or chronic medical illness, including unstable angina, recent myocardial infarction, history of congestive heart failure, preexisting hypotension (systolic < 110), or orthostatic hypotension (systolic drop > 20mmHg after two minutes standing or any drop with dizziness), insulin-dependent diabetes mellitus; chronic renal or hepatic failure, pancreatitis, gout, M ni re's disease, benign positional vertigo, narcolepsy
Concomitant use of alpha-1 antagonists History of prazosin-sensitivity Women who are pregnant, nursing infant(s), or of childbearing potential and not using a contraceptive method judged by the investigator to be effective
Non-compliance with outpatient chemical dependency treatment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00240227

Contacts


Contact: Charles W Meredith, MD		charles.meredith@med.va.gov

Locations


United States, Washington
	VA Puget Sound Health Care System	Recruiting
	Seattle, Washington, United States, 98109
	Contact: Charles W Meredith, MD charles.meredith@med.va.gov
	Principal Investigator: Andrew J. Saxon, MD

Sponsors and Collaborators

Department of Veterans Affairs

Investigators


Principal Investigator:	Andrew J. Saxon, MD	VA Puget Sound Health Care System

More Information

drugs.com PDR information on the study drug This link exits the ClinicalTrials.gov site

Publications of Results:

Ehrman RN, Robbins SJ, Childress AR, O'Brien CP. Conditioned responses to cocaine-related stimuli in cocaine abuse patients. Psychopharmacology (Berl). 1992;107(4):523-9.

O'Brien CP, Childress AR, McLellan AT. Conditioning factors may help to understand and prevent relapse in patients who are recovering from drug dependence. NIDA Res Monogr. 1991;106:293-312. Review. No abstract available.

Childress AR, McLellan AT, O'Brien CP. Behavioral therapies for substance abuse. Int J Addict. 1985 Jun-Jul;20(6-7):947-69. Review.

McLellan AT, Childress AR, Ehrman R, O'Brien CP, Pashko S. Extinguishing conditioned responses during opiate dependence treatment turning laboratory findings into clinical procedures. J Subst Abuse Treat. 1986;3(1):33-40.

Childress AR, Mozley PD, McElgin W, Fitzgerald J, Reivich M, O'Brien CP. Limbic activation during cue-induced cocaine craving. Am J Psychiatry. 1999 Jan;156(1):11-8.

Volkow ND, Wang GJ, Fowler JS, Hitzemann R, Angrist B, Gatley SJ, Logan J, Ding YS, Pappas N. Association of methylphenidate-induced craving with changes in right striato-orbitofrontal metabolism in cocaine abusers: implications in addiction. Am J Psychiatry. 1999 Jan;156(1):19-26.

Responsible Party:	Department of Veterans Affairs ( Saxon, Andrew - Principal Investigator )
Study ID Numbers:	REAP 05-0020
First Received:	October 13, 2005
Last Updated:	August 26, 2008
ClinicalTrials.gov Identifier:	NCT00240227
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

Alcoholism

Cocaine Dependence

Prazosin

Substance use disorders

Study placed in the following topic categories:

Cocaine-Related Disorders

Dopamine

Prazosin

Mental Disorders

Alcoholism

Substance-Related Disorders

Disorders of Environmental Origin

Alcohol-Related Disorders

Cocaine

Ethanol

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors

Neurotransmitter Agents

Neurotransmitter Uptake Inhibitors

Adrenergic Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Anesthetics

Central Nervous System Depressants

Adrenergic alpha-Antagonists

Cardiovascular Agents

Antihypertensive Agents

Pharmacologic Actions

Anesthetics, Local

Sensory System Agents

Therapeutic Uses

Vasoconstrictor Agents

Adrenergic Antagonists

Dopamine Agents

Peripheral Nervous System Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00240227