Trial Outcomes & Findings for Effects of Sulfasalazine on BOLD Response to Alcohol Cues (NCT NCT01312129)

Last Updated: 2014-09-22

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

23 participants

Primary outcome timeframe

Over two weeks

Results posted on

2014-09-22

Participant Flow

Participants recruited in Albuquerque, NM between March 2011 and August 2011.

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.

Participant milestones

Participant milestones
Measure	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.
First Intervention (24 Hours) STARTED	6	7
First Intervention (24 Hours) Control Cue	6	7
First Intervention (24 Hours) Alcohol Cue	6	7
First Intervention (24 Hours) COMPLETED	6	7
First Intervention (24 Hours) NOT COMPLETED	0	0
Washout (1 Week) STARTED	6	7
Washout (1 Week) COMPLETED	6	7
Washout (1 Week) NOT COMPLETED	0	0
Second Intervention (24 Hours) STARTED	6	7
Second Intervention (24 Hours) Control Cue	6	6
Second Intervention (24 Hours) Alcohol Cue	6	6
Second Intervention (24 Hours) COMPLETED	6	6
Second Intervention (24 Hours) NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Second Intervention (24 Hours) Lost to Follow-up	0	1

Baseline Characteristics

Effects of Sulfasalazine on BOLD Response to Alcohol Cues

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo First, Then Sulfasalazine n=6 Participants 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 n=7 Participants 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 n=13 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	7 participants n=7 Participants	13 participants n=5 Participants

PRIMARY outcome

Timeframe: Over two weeks

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Placebo x 3 doses 12 hours apart	Sulfasalazine n=12 Participants Sulfasalazine capsule, 500mg, x 3 doses 12 hours.
% BOLD Response Increase Above Baseline Control Cue	.106 % BOLD Response increase above baseline Standard Deviation .140	.082 % BOLD Response increase above baseline Standard Deviation .156
% BOLD Response Increase Above Baseline Alcohol Cue	.074 % BOLD Response increase above baseline Standard Deviation .167	.097 % BOLD Response increase above baseline Standard Deviation .125

Adverse Events

Placebo First, Then Sulfasalazine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sulfasalazine First, Then Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kent Hutchison, Ph.D.

The Mind Research Network

Phone: 720-663-0745

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place