Effects of Sulfasalazine on BOLD Response to Alcohol Cues

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kent Hutchison, Ph.D., The Mind Research Network
ClinicalTrials.gov Identifier:
NCT01312129
First received: March 9, 2011
Last updated: September 18, 2014
Last verified: September 2014
Results First Received: May 30, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Alcohol Dependence
Interventions: Drug: Sulfasalazine
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
Participants recruited in Albuquerque, NM between March 2011 and August 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
23 participants were recruited; 10 excluded; 13 approved; 1 participant lost to follow-up; 12 participants completed protocol. Of the 12 participants who completed the protocol, each received both interventions: Sulfasalazine first, then placebo, as well as, Placebo first, then Sulfasalazine. Subjects were randomized to intervention order.

Reporting Groups
  Description
Placebo First, Then Sulfasalzine Placebo x 3 doses 12 hours apart in the first session, followed by a washout period of 7 days, then Sulfasalazine capsule, 500mg, x 3 doses 12 hours apart in the second session (Sulfasalazine 1500mg total)
Sulfasalazine First, Then Placebo Sulfasalazine capsule, 500mg, x 3 doses 12 hours apart in the first session (Sulfasalazine 1500mg total) followed by a washout period of 7 days, then Placebo capsule x 3 doses 12 hours apart in the second session.

Participant Flow for 3 periods

Period 1:   First Intervention (24 Hours)
    Placebo First, Then Sulfasalzine     Sulfasalazine First, Then Placebo  
STARTED     6     7  
Control Cue     6     7  
Alcohol Cue     6     7  
COMPLETED     6     7  
NOT COMPLETED     0     0  

Period 2:   Washout (1 Week)
    Placebo First, Then Sulfasalzine     Sulfasalazine First, Then Placebo  
STARTED     6     7  
COMPLETED     6     7  
NOT COMPLETED     0     0  

Period 3:   Second Intervention (24 Hours)
    Placebo First, Then Sulfasalzine     Sulfasalazine First, Then Placebo  
STARTED     6     7  
Control Cue     6     6  
Alcohol Cue     6     6  
COMPLETED     6     6  
NOT COMPLETED     0     1  
Lost to Follow-up                 0                 1  



  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
Placebo First, Then Sulfasalazine Placebo x 3 doses 12 hours apart in the first session, followed by a washout period of 7 days, then Sulfasalazine capsule, 500mg, x 3 doses 12 hours apart in the second session (Sulfasalazine 1500mg total)
Sulfasalazine First, Then Placebo Sulfasalazine capsule, 500mg, x 3 doses 12 hours apart in the first session (Sulfasalazine 1500mg total) followed by a washout period of 7 days, then Placebo capsule x 3 doses 12 hours apart in the second session.
Total Total of all reporting groups

Baseline Measures
    Placebo First, Then Sulfasalazine     Sulfasalazine First, Then Placebo     Total  
Number of Participants  
[units: participants]
  6     7     13  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     6     7     13  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     3     1     4  
Male     3     6     9  
Region of Enrollment  
[units: participants]
     
United States     6     7     13  



  Outcome Measures

1.  Primary:   % BOLD Response Increase Above Baseline   [ Time Frame: Over two weeks ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Kent Hutchison, Ph.D.
Organization: The Mind Research Network
phone: 720-663-0745
e-mail: khutchison@mrn.org


No publications provided


Responsible Party: Kent Hutchison, Ph.D., The Mind Research Network
ClinicalTrials.gov Identifier: NCT01312129     History of Changes
Other Study ID Numbers: 20-381
Study First Received: March 9, 2011
Results First Received: May 30, 2013
Last Updated: September 18, 2014
Health Authority: United States: Food and Drug Administration