Prazosin for ETOH or Cocaine Craving

This study has been terminated.
(Experimental procedure did not induce sufficient craving to determine any possible effect of medication.)
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00240227
First received: October 13, 2005
Last updated: March 11, 2016
Last verified: March 2016
  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
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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 VA Office of Research and Development:

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 to 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: 8
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
Placebo
Placebo no active medication
Drug: placebo
Active Comparator: prazosin
Prazosin flexible dose titration up to 12 mg per day.
Drug: Prazosin
FDA approved medication for hypertension
Other Name: Mini Press

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
VA Office of Research and Development
Investigators
Principal Investigator: Andrew J. Saxon, MD VA Puget Sound Health Care System
  More Information

Additional Information:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00240227     History of Changes
Other Study ID Numbers: REAP 05-0020 
Study First Received: October 13, 2005
Results First Received: November 25, 2013
Last Updated: March 11, 2016
Health Authority: United States: Federal Government

Keywords provided by VA Office of Research and Development:
Alcoholism
Cocaine Dependence
Prazosin
Substance use disorders

Additional relevant MeSH terms:
Alcoholism
Cocaine-Related Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Cocaine
Prazosin
Adrenergic Antagonists
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Antihypertensive Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Agents

ClinicalTrials.gov processed this record on July 26, 2016