Prazosin for ETOH or Cocaine Craving
This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00240227
First received: October 13, 2005
Last updated: June 22, 2011
Last verified: June 2011
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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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
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 ]
| Enrollment: | 32 |
| Study Start Date: | April 2004 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | January 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
Locations
| United States, Washington | |
| VA Puget Sound Health Care System | |
| Seattle, Washington, United States, 98109 | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Andrew J. Saxon, MD | VA Puget Sound Health Care System |
More Information
Additional Information:
No publications provided
| Responsible Party: | Saxon, Andrew - Principal Investigator, Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00240227 History of Changes |
| Other Study ID Numbers: | REAP 05-0020 |
| Study First Received: | October 13, 2005 |
| Last Updated: | June 22, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Alcoholism Cocaine Dependence Prazosin Substance use disorders |
Additional relevant MeSH terms:
|
Alcoholism Cocaine-Related Disorders Alcohol-Related Disorders Substance-Related Disorders Mental Disorders Cocaine Prazosin Adrenergic Antagonists Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Dopamine Uptake Inhibitors Dopamine Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Anesthetics, Local Anesthetics Central Nervous System Depressants Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Antihypertensive Agents Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists Adrenergic Agents |
ClinicalTrials.gov processed this record on May 23, 2013