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Prazosin for ETOH or Cocaine Craving

Primary Purpose

Alcoholism, Cocaine Dependence

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prazosin
placebo
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism focused on measuring Alcoholism, Cocaine Dependence, Prazosin, Substance use disorders

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Puget Sound Health Care System

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Placebo

prazosin

Arm Description

Placebo no active medication

Prazosin flexible dose titration up to 12 mg per day.

Outcomes

Primary Outcome Measures

Change in Skin Conductance Response in Response to Provocative Visual Cues Designed to Elicit Craving, Compared to Placebo Group

Secondary Outcome Measures

Change in Heart Rate Response in Response to Provocative Visual Cues Designed to Elicit Craving, Compared to Placebo Group
Change in Blood Pressure Response in Response to Provocative Visual Cues Designed to Elicit Craving, Compared to Placebo Group
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
Change in Self-reports of Substance Use Between Study Medication and Placebo Periods
Change in Urine Drug Analysis Results Between Study Medication and Placebo Periods

Full Information

First Posted
October 13, 2005
Last Updated
August 1, 2018
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00240227
Brief Title
Prazosin for ETOH or Cocaine Craving
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
Experimental procedure did not induce sufficient craving to determine any possible effect of medication.
Study Start Date
April 2004 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Objective of the project: To evaluate the efficacy of prazosin on the reduction of craving in alcohol and cocaine dependent individuals. The investigators hypothesize that prazosin will be more effective than placebo in the reduction of craving that is stimulated by exposure to visual cues or to intolerance to stress in individuals dependent on cocaine and in individuals dependent on alcohol. Specifically, the investigators hypothesize that in this laboratory study: Subjects in the prazosin condition will report a reduction in craving induced in the laboratory by exposure to visual cues compared to subjects in the placebo condition. Subjects in the prazosin condition will show less reaction of the noradrenergic system when craving is induced in the laboratory by exposure to visual cues compared to subjects in the placebo condition. Subjects will be less likely to relapse to their drug of choice while they are in the prazosin condition compared to when they are in the placebo condition. Most individuals who are able to achieve sobriety in chemical dependency treatment eventually relapse. Until the investigators can prevent the cravings for drugs, which usually precedes relapse, it is unlikely that the investigators will have more effective treatment for drug addiction. Our final hypothesis is that the alpha-1, adrenergic antagonist, prazosin, will prove to be an effective pharmacological agent for treatment of drug dependency. Research plan study design: The proposed study will be a double-blind, placebo-controlled, crossover study of prazosin in subjects who are either dependent on alcohol or on cocaine, and who have been able to achieve one month of sobriety while in intensive outpatient treatment. The double-blind, crossover protocol will last 8 weeks and will include 32 subjects; 16 of whom are alcohol-dependent, and 16 of whom are cocaine-dependent. The focus of this first study will be on subjective and physiological measures of craving that will be induced in a controlled setting by exposure to visual cues. Methodology Setting: This study will occur in room 6A-107 in Building 1 at the Veterans Administration Puget Sound Health Care System in Seattle. This is a soundproof room specifically designed and constructed for studies of this type. Participants: 16 alcohol-dependent adults and 16 cocaine-dependent adults presenting for chemical dependency treatment at the VA Puget Sound Health Care System (VAPSHCS) Addiction Treatment Center. Study Procedures: Once potential subjects have provided their consent to participate in the study, they will undergo a 2 hour baseline assessment that consists of some pencil and paper questionnaires, providing a medical and psychiatric history, and a physical exam. They will provide blood for some basic screening labs to insure they are healthy enough to proceed with the study, and have their baseline vital signs measured. Veterans who are screened for the study will then be enrolled once their lab results and the screening process have determined that they do not meet any medical exclusion criteria. At that point, participants will be randomized to either the study medication or placebo. During the course of the study, participants continue with their outpatient chemical dependency treatment through the Addiction Treatment Center at the VA Puget Sound. During the eight weeks of the study, participants will have weekly orthostatic vital sign and adverse events monitoring by the study nurse or physician. All serious or unexpected adverse events will be reported to the FDA and UW Human Subjects Committee in accordance with requirements. Participants will also provide self-reports of drug or alcohol use and urine drug analysis specimens at these weekly visits. At the end of week 4, each participant will be tested in a 1 hour craving session in room 6A-107 at VA Puget Sound. Subjects will have their heart rate and skin conductance response continuously measured, and have their blood pressure measured every 5 minutes. They will be shown 5 1-minute films, 3 of which are designed to be neutral and 2 of which are designed to provoke craving for their drug of choice. They will be asked to complete a subjective scale of craving prior to each video and after the last video. Participants will not be permitted to leave the craving lab after the last film, until they feel that they have subjectively returned to a level of normal physiological arousal and are no longer experiencing any craving. Findings: No findings to date.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism, Cocaine Dependence
Keywords
Alcoholism, Cocaine Dependence, Prazosin, Substance use disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Other
Arm Description
Placebo no active medication
Arm Title
prazosin
Arm Type
Active Comparator
Arm Description
Prazosin flexible dose titration up to 12 mg per day.
Intervention Type
Drug
Intervention Name(s)
Prazosin
Other Intervention Name(s)
Mini Press
Intervention Description
FDA approved medication for hypertension
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Change in Skin Conductance Response in Response to Provocative Visual Cues Designed to Elicit Craving, Compared to Placebo Group
Time Frame
During lab session
Secondary Outcome Measure Information:
Title
Change in Heart Rate Response in Response to Provocative Visual Cues Designed to Elicit Craving, Compared to Placebo Group
Time Frame
During lab session
Title
Change in Blood Pressure Response in Response to Provocative Visual Cues Designed to Elicit Craving, Compared to Placebo Group
Time Frame
During lab session
Title
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
Title
Change in Self-reports of Substance Use Between Study Medication and Placebo Periods
Time Frame
4 weeks
Title
Change in Urine Drug Analysis Results Between Study Medication and Placebo Periods
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew J. Saxon, MD
Organizational Affiliation
VA Puget Sound Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Puget Sound Health Care System
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.drugs.com/pdr/minipress.html
Description
drugs.com PDR information on the study drug

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Prazosin for ETOH or Cocaine Craving

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