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Prazosin to Reduce Stress-Induced Cocaine/Alcohol Craving and Relapse
This study is currently recruiting participants.
Verified by Yale University, December 2007
First Received: December 25, 2007   Last Updated: January 2, 2008   History of Changes
Sponsors and Collaborators: Yale University
National Institutes of Health (NIH)
Information provided by: Yale University
ClinicalTrials.gov Identifier: NCT00585780
  Purpose

To test the preliminary efficacy of 16.0 mg of Prazosin daily versus placebo in treatment seeking cocaine and/or alcohol dependent individuals. This proposal is a laboratory and treatment outcome study to examine the effects of Prazosin on brief exposure to stress, drug cues and neutral situations on cocaine/alcohol craving, mood and neurobiological reactivity in a sample of cocaine and/or alcohol dependent individuals. Prazosin will be beneficial for reduction in stress and drug cue induced craving and related arousal. In a sample of 60 cocaine and/or alcohol dependent men and women, we propose to examine (a) differences in measures of cocaine craving, emotion state, hypothalamic-pituitary-adrenal (HPA) activation, physiological arousal and plasma catecholamine response to stress imagery and to drug cue imagery as compared to neutral imagery; (b) reduction in cocaine/alcohol abstinence symptoms; and (c) improvement in cocaine and alcohol treatment outcomes as measured by increasing abstinence, reduction in cocaine/alcohol use and increased treatment attendance.


Condition Intervention Phase
Cocaine Dependence
Alcohol Dependence
Drug: Prazosin
Drug: placebo
Phase I

MedlinePlus related topics: Alcoholism
Drug Information available for: Prazosin Prazosin hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Prazosin to Reduce Stress-Induced Cocaine/Alcohol Craving and Relapse

Further study details as provided by Yale University:

Primary Outcome Measures:
  • cocaine/alcohol use as measured by weekly urine drug screens/breathalyzer reports and self report of drug use and treatment adherence as measured by frequency of attendance [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2007
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
PZ: Active Comparator
Prazosin
Drug: Prazosin
4.0mg in the morning, 4.0mg at 3pm, and 8.0mg at bedtime for 8 weeks
PLA: Placebo Comparator
placebo
Drug: placebo
placebo

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female individuals, ages 18-50, meeting current DSM-IV criteria for cocaine and/or alcohol dependence.
  • COCAINE SAMPLE: meet current DSM-IV criteria for cocaine dependence; documented positive urine toxicology screen for cocaine at intake
  • ALCOHOLIC SAMPLE: meet current DSM-IV criteria for alcohol dependence
  • Subject has voluntarily given informed consent and signed the informed consent document.
  • Able to read English and complete study evaluations.

Exclusion Criteria:

  • Meet current criteria for dependence on another psychoactive substance, excluding nicotine and caffeine;
  • Any current use of opiates or past history of opiate abuse/dependence;
  • Current use of any psychoactive drugs, including anxiolytics, antidepressants, naltrexone or antabuse;
  • Any psychotic disorder or current Axis I psychiatric symptoms requiring specific attention, including need for psychiatric medications for current major depression and anxiety disorders
  • Significant underlying medical conditions such as cerebral, renal, thyroid or cardiac pathology which in the opinion of study physician would preclude patient from fully cooperating or be of potential harm during the course of the study;
  • Abstinent from cocaine for more than two weeks prior to admission.
  • Hypotensive individuals with sitting blood pressure below 90/50 mmHG.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00585780

Contacts
Contact: Keri L Bergquist, Psy.D. 203-974-7360 keri.bergquist@yale.edu

Locations
United States, Connecticut
Yale University School of Medicine: Research Program on Stress, Addiction, and Psychopathology Recruiting
New Haven, Connecticut, United States, 06519
Contact: Keri L Bergquist, Psy.D.     203-974-7360     keri.bergquist@yale.edu    
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Rajita Sinha, PhD Yale University
  More Information

No publications provided

Responsible Party: Yale University School of Medicine ( Rajita Sinha, PhD: Professor )
Study ID Numbers: 0705002691, P50-DA016556
Study First Received: December 25, 2007
Last Updated: January 2, 2008
ClinicalTrials.gov Identifier: NCT00585780     History of Changes
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Cocaine-Related Disorders
Neurotransmitter Agents
Adrenergic Agents
Stress
Disorders of Environmental Origin
Cardiovascular Agents
Adrenergic alpha-Antagonists
Antihypertensive Agents
Mental Disorders
Prazosin
Alcoholism
Substance-Related Disorders
Alcohol-Related Disorders
Adrenergic Antagonists
Cocaine
Ethanol

Additional relevant MeSH terms:
Cocaine-Related Disorders
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Disorders of Environmental Origin
Cardiovascular Agents
Adrenergic alpha-Antagonists
Antihypertensive Agents
Pharmacologic Actions
Mental Disorders
Prazosin
Therapeutic Uses
Alcoholism
Substance-Related Disorders
Alcohol-Related Disorders
Adrenergic Antagonists

ClinicalTrials.gov processed this record on May 07, 2009