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Effects of Sulfasalazine on BOLD Response to Alcohol Cues

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ClinicalTrials.gov Identifier: NCT01312129
Recruitment Status : Completed
First Posted : March 10, 2011
Results First Posted : September 22, 2014
Last Update Posted : September 22, 2014
Sponsor:
Information provided by (Responsible Party):
Kent Hutchison, Ph.D., The Mind Research Network

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Alcohol Dependence
Interventions Drug: Sulfasalazine
Drug: Placebo
Enrollment 23
Recruitment Details Participants recruited in Albuquerque, NM between March 2011 and August 2011.
Pre-assignment Details 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.
Arm/Group Title Placebo First, Then Sulfasalzine Sulfasalazine First, Then Placebo
Hide Arm/Group Description 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 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.
Period Title: First Intervention (24 Hours)
Started 6 7
Control Cue 6 7
Alcohol Cue 6 7
Completed 6 7
Not Completed 0 0
Period Title: Washout (1 Week)
Started 6 7
Completed 6 7
Not Completed 0 0
Period Title: Second Intervention (24 Hours)
Started 6 7
Control Cue 6 6
Alcohol Cue 6 6
Completed 6 6
Not Completed 0 1
Reason Not Completed
Lost to Follow-up             0             1
Arm/Group Title Placebo First, Then Sulfasalazine Sulfasalazine First, Then Placebo Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 6 7 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 7 participants 13 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
 100.0%
7
 100.0%
13
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 7 participants 13 participants
Female
3
  50.0%
1
  14.3%
4
  30.8%
Male
3
  50.0%
6
  85.7%
9
  69.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 7 participants 13 participants
6 7 13
1.Primary Outcome
Title % BOLD Response Increase Above Baseline
Hide Description Test whether Sulfasalazine, as compared to placebo, diminishes blood-oxygen-level dependent (BOLD) response to alcohol cues in the striatum and prefrontal cortex (PFC). BOLD response refers to brain activation in response to the presence of oxygen in a particular part of the brain. To test the hypothesis, we will compare Sulfasalazine treatment with placebo treatment. During the fMRI scan session, participants will be presented with the alcohol cue task. We will compare the difference in BOLD response during the presence of alcohol vs. a novel substance during the alcohol cue task. Outcome data collected during the alcohol cue task will provide us with BOLD response data for each intervention period. We will analyze the outcome data using FSL (Oxford Centre for Functional MRI of the Brain (FMRIB) Software - a collection of functional and structural brain image analysis tools).
Time Frame Over two weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Sulfasalazine
Hide Arm/Group Description:
Placebo x 3 doses 12 hours apart
Sulfasalazine capsule, 500mg, x 3 doses 12 hours.
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: % BOLD Response increase above baseline
Control Cue .106  (.140) .082  (.156)
Alcohol Cue .074  (.167) .097  (.125)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sulfasalazine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =.05
Comments =0.05 is the actual computed p-value via the ANOVA.
Method ANOVA
Comments The ANOVA is comparing the % increase in BOLD response above baseline during cue presentation (Alcohol vs. Control) b/w placebo & Sulfasalazine .
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo First, Then Sulfasalazine Sulfasalazine First, Then Placebo
Hide Arm/Group Description 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 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.
All-Cause Mortality
Placebo First, Then Sulfasalazine Sulfasalazine First, Then Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Placebo First, Then Sulfasalazine Sulfasalazine First, Then Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/7 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Placebo First, Then Sulfasalazine Sulfasalazine First, Then Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/7 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Kent Hutchison, Ph.D.
Organization: The Mind Research Network
Phone: 720-663-0745
EMail: khutchison@mrn.org
Layout table for additonal information
Responsible Party: Kent Hutchison, Ph.D., The Mind Research Network
ClinicalTrials.gov Identifier: NCT01312129    
Other Study ID Numbers: 20-381
First Submitted: March 9, 2011
First Posted: March 10, 2011
Results First Submitted: May 30, 2013
Results First Posted: September 22, 2014
Last Update Posted: September 22, 2014