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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
Results First Received: November 25, 2013  
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
Conditions: Alcoholism
Cocaine Dependence
Interventions: Drug: Prazosin
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were randomized to one of two sequences, either placebo first or prazosin first. However, the precise numbers of which sequence participants were randomized to are no longer available considering the time (7 years) since the study was completed.

Reporting Groups
  Description
All Study Participants

Placebo no active medication

placebo

Prazosin flexible dose titration up to 12 mg per day.

Prazosin: FDA approved medication for hypertension


Participant Flow:   Overall Study
    All Study Participants  
STARTED     8  
COMPLETED     8  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All Study Paricipants

Placebo no active medication

placebo

Prazosin

FDA approved medication for hypertension


Baseline Measures
    All Study Paricipants  
Number of Participants  
[units: participants]
  8  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     8  
>=65 years     0  
Age  
[units: years]
Mean (Standard Deviation)
  42  (8)  
Gender  
[units: participants]
 
Female     0  
Male     8  
Region of Enrollment  
[units: participants]
 
United States     8  



  Outcome Measures

1.  Primary:   Change in Skin Conductance Response in Response to Provocative Visual Cues Designed to Elicit Craving, Compared to Placebo Group   [ Time Frame: During lab session ]

2.  Secondary:   Change in Heart Rate Response in Response to Provocative Visual Cues Designed to Elicit Craving, Compared to Placebo Group   [ Time Frame: During lab session ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Change in Blood Pressure Response in Response to Provocative Visual Cues Designed to Elicit Craving, Compared to Placebo Group   [ Time Frame: During lab session ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Change in Self-reports of Substance Use Between Study Medication and Placebo Periods   [ Time Frame: 4 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Change in Urine Drug Analysis Results Between Study Medication and Placebo Periods   [ Time Frame: 4 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study procedure intended to induce substance craving failed to induce craving. Thus, any difference between placebo and active medication conditions could not be measured and so the study was terminated.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Andrew J. Saxon, M.D.
Organization: VA Puget Sound Health Care System
phone: 206-764-2782
e-mail: andrew.saxon@va.gov



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