Trial Outcomes & Findings for Psychopharmacology for Cocaine Dependence - Buspirone (NCT NCT01267292)

NCT ID: NCT01267292

Last Updated: 2017-05-04

Results Overview

The mean score over all 4 time points is reported in this outcome measure (i.e., a summary score is reported). Each subject contributed 1 data point for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 20 data points per dose level per arm. The Stroop task assesses attentional biases to cocaine-related (drug-related) and rewarding (non-drug related) stimuli vs. neutral stimuli. Participants are instructed to respond to words shown in different colors on the screen, by pressing as quickly and accurately as possible on one of three colored buttons. Attentional bias is measured as the difference in reaction times on cocaine vs. neutral words. The reported score is a difference score in milliseconds (cocaine minus neutral), in which positive means slower to respond to cocaine and thus greater attentional bias, and negative means no attentional bias to cocaine words.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 50 participants
• Primary outcome timeframe: 1 time a day on Wednesday and Friday of week 2; 1 time a day on Monday and Wednesday of week 3
• Results posted on: 2017-05-04

Participant Flow

Participant milestones

Measure	Buspirone Plus Methylphenidate \[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo\] \[week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\] \[week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\]	Placebo for Buspirone Plus Methylphenidate \[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo\] \[week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\] \[week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\]
Overall Study STARTED	24	26
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	4	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Psychopharmacology for Cocaine Dependence - Buspirone

Baseline characteristics by cohort

Measure	Buspirone Plus Methylphenidate n=20 Participants \[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo\] \[week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\] \[week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\]	Placebo for Buspirone Plus Methylphenidate n=20 Participants \[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo\] \[week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\] \[week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\]	Total n=40 Participants Total of all reporting groups
Age, Continuous	41.7 years STANDARD_DEVIATION 7.82 • n=5 Participants	44.15 years STANDARD_DEVIATION 7.23 • n=7 Participants	42.925 years STANDARD_DEVIATION 7.525 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	16 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants
Attentional Bias as assessed by score on the Stroop task	12.39759 milliseconds STANDARD_DEVIATION 70.25051 • n=5 Participants	28.67933 milliseconds STANDARD_DEVIATION 69.99501 • n=7 Participants	20.53846 milliseconds STANDARD_DEVIATION 70.12276 • n=5 Participants
Risky decision making as assessed by score on the risky decision making task	9.778235 units on a scale STANDARD_DEVIATION 7.368139 • n=5 Participants	8.945935 units on a scale STANDARD_DEVIATION 5.512101 • n=7 Participants	9.362085 units on a scale STANDARD_DEVIATION 6.44012 • n=5 Participants
Subjective Effects as assessed by score on the Vigor Subscale of the Profile of Mood States (POMS)	5.989247 units on a scale STANDARD_DEVIATION 6.306573 • n=5 Participants	5.080925 units on a scale STANDARD_DEVIATION 5.594259 • n=7 Participants	5.535086 units on a scale STANDARD_DEVIATION 5.950416 • n=5 Participants
Subjective Effects as assessed by Score on "Feel High" Subscale of the Drug Effects Questionnaire	15.32065 units on a scale STANDARD_DEVIATION 25.31205 • n=5 Participants	8.128655 units on a scale STANDARD_DEVIATION 17.20622 • n=7 Participants	11.7246525 units on a scale STANDARD_DEVIATION 21.259135 • n=5 Participants
Subjective Effects as assessed by the "elated" subscale of the visual analogue scale (VAS)	22.00538 units on a scale STANDARD_DEVIATION 26.22491 • n=5 Participants	20.4593 units on a scale STANDARD_DEVIATION 26.25991 • n=7 Participants	21.23234 units on a scale STANDARD_DEVIATION 26.24241 • n=5 Participants
Heart rate	65.42781 beats per minute STANDARD_DEVIATION 11.223 • n=5 Participants	64.44886 beats per minute STANDARD_DEVIATION 11.28527 • n=7 Participants	64.938335 beats per minute STANDARD_DEVIATION 11.254135 • n=5 Participants
Systolic blood pressure	117.4813 mmHg STANDARD_DEVIATION 14.13086 • n=5 Participants	113.2727 mmHg STANDARD_DEVIATION 11.94963 • n=7 Participants	115.377 mmHg STANDARD_DEVIATION 13.040245 • n=5 Participants
Diastolic blood pressure	74.52406 mmHg STANDARD_DEVIATION 8.30489 • n=5 Participants	75.34091 mmHg STANDARD_DEVIATION 8.234265 • n=7 Participants	74.932485 mmHg STANDARD_DEVIATION 8.2695775 • n=5 Participants

PRIMARY outcome

Timeframe: 1 time a day on Wednesday and Friday of week 2; 1 time a day on Monday and Wednesday of week 3

The mean score over all 4 time points is reported in this outcome measure (i.e., a summary score is reported). Each subject contributed 1 data point for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 20 data points per dose level per arm.

The Stroop task assesses attentional biases to cocaine-related (drug-related) and rewarding (non-drug related) stimuli vs. neutral stimuli. Participants are instructed to respond to words shown in different colors on the screen, by pressing as quickly and accurately as possible on one of three colored buttons. Attentional bias is measured as the difference in reaction times on cocaine vs. neutral words. The reported score is a difference score in milliseconds (cocaine minus neutral), in which positive means slower to respond to cocaine and thus greater attentional bias, and negative means no attentional bias to cocaine words.

Outcome measures

Measure	Buspirone Plus Methylphenidate n=20 Participants \[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo\] \[week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\] \[week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\]	Placebo for Buspirone Plus Methylphenidate n=20 Participants \[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo\] \[week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\] \[week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\]
Attentional Bias as Assessed by Score on the Stroop Task 60 mg methylphenidate	15.59167 milliseconds Standard Deviation 142.0095	23.28063 milliseconds Standard Deviation 42.25839
Attentional Bias as Assessed by Score on the Stroop Task 15 mg methylphenidate	-13.90333 milliseconds Standard Deviation 62.76434	27.118 milliseconds Standard Deviation 58.84988
Attentional Bias as Assessed by Score on the Stroop Task 30 mg methylphenidate	-9.361269 milliseconds Standard Deviation 30.66139	15.35407 milliseconds Standard Deviation 66.51272
Attentional Bias as Assessed by Score on the Stroop Task 0 mg methylphenidate	4.688844 milliseconds Standard Deviation 30.59728	41.22625 milliseconds Standard Deviation 74.82985

PRIMARY outcome

Timeframe: 1 time a day on Wednesday and Friday of week 2; 1 time a day on Monday and Wednesday of week 3

The mean score over all 4 time points is reported in this outcome measure (i.e., a summary score is reported). Each subject contributed 1 data point for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 20 data points per dose level per arm.

The risky decision making task provides subjects with three choice options on each of 100 repeated trials. Options are low, moderate, and high risk, based on variance and probability in gain/loss amounts. The low risk option is more adaptive over many trials. The outcome measure is a risk index (ranging from 0.33 to 100) that factors in tolerance for variability and amount of gains and losses across the three options. 100 is highest risk. 0.33 is lowest risk.

Outcome measures

Measure	Buspirone Plus Methylphenidate n=20 Participants \[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo\] \[week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\] \[week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\]	Placebo for Buspirone Plus Methylphenidate n=20 Participants \[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo\] \[week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\] \[week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\]
Risky Decision Making as Assessed by Score on the Risky Decision Making Task 15mg Methylphenidate	9.126667 units on a scale Standard Deviation 5.094545	10.07396 units on a scale Standard Deviation 5.44448
Risky Decision Making as Assessed by Score on the Risky Decision Making Task 30mg Methylphenidate	10.77167 units on a scale Standard Deviation 6.58645	9.699333 units on a scale Standard Deviation 6.334753
Risky Decision Making as Assessed by Score on the Risky Decision Making Task 60mg Methylphenidate	8.946263 units on a scale Standard Deviation 6.947867	7.889825 units on a scale Standard Deviation 5.277534
Risky Decision Making as Assessed by Score on the Risky Decision Making Task 0mg Methylphenidate	11.415 units on a scale Standard Deviation 6.147164	8.715333 units on a scale Standard Deviation 6.34345

SECONDARY outcome

Timeframe: 11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3

Population: ARCI data were not collected.

The ARCI short form will be used. It is a 49-item true / false questionnaire that has been empirically-derived to assess five different factors, including euphoria, sedation, and dysphoria. The PCAG scale has proven to be a sensitive measure of subjective effects in many studies administering stimulant drugs.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3

The mean score over all 44 time points is reported in this outcome measure (i.e., the summary score is reported). Each subject contributed 11 data points for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 220 data points per dose level per arm.

The POMS is a self-rating measure of current mood, consisting of six subscales demonstrated to be sensitive to a range of acute drug effects, including amphetamine, cocaine, and caffeine. The six subscales are: depression, vigor, confusion, tension, anxiety, and fatigue. A 37-item short form of the POMS was used, which correlates highly with the full scale. The vigor subscale is reported, and the vigor subscale score ranges from 0 to 28, with 28 representing the highest score for that mood state. The higher the value, the worse the outcome.

Outcome measures

Measure	Buspirone Plus Methylphenidate n=20 Participants \[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo\] \[week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\] \[week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\]	Placebo for Buspirone Plus Methylphenidate n=20 Participants \[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo\] \[week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\] \[week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\]
Subjective Effects as Assessed by Score on the Vigor Subscale of the Profile of Mood States (POMS) 15mg Methylphenidate	4.609626 units on a scale Standard Deviation 5.775599	3.770115 units on a scale Standard Deviation 4.558423
Subjective Effects as Assessed by Score on the Vigor Subscale of the Profile of Mood States (POMS) 0mg Methylphenidate	6.16129 units on a scale Standard Deviation 6.520306	5.735632 units on a scale Standard Deviation 5.360873
Subjective Effects as Assessed by Score on the Vigor Subscale of the Profile of Mood States (POMS) 30mg Methylphenidate	9.924324 units on a scale Standard Deviation 6.630357	6.268571 units on a scale Standard Deviation 5.721696
Subjective Effects as Assessed by Score on the Vigor Subscale of the Profile of Mood States (POMS) 60mg Methylphenidate	4.745946 units on a scale Standard Deviation 5.702335	5.874286 units on a scale Standard Deviation 5.866932

SECONDARY outcome

Timeframe: 11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3

The mean score over all 44 time points is reported in this outcome measure (i.e., the summary score is reported). Each subject contributed 11 data points for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 220 data points per dose level per arm.

The DEQ is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: "Feel Drug," "Feel High," "Like Drug," and "Want More." The "Feel High" subscale is reported, and this subscale is scored on a visual analogue scale (scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome.

Outcome measures

Measure	Buspirone Plus Methylphenidate n=20 Participants \[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo\] \[week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\] \[week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\]	Placebo for Buspirone Plus Methylphenidate n=20 Participants \[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo\] \[week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\] \[week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\]
Subjective Effects as Assessed by Score on the "Feel High" Subscale of the Drug Effects Questionnaire (DEQ) 15mg Methylphenidate	9.322581 units on a scale Standard Deviation 17.49543	9.178161 units on a scale Standard Deviation 17.58439
Subjective Effects as Assessed by Score on the "Feel High" Subscale of the Drug Effects Questionnaire (DEQ) 30mg Methylphenidate	12.71351 units on a scale Standard Deviation 22.32222	10.78857 units on a scale Standard Deviation 17.63701
Subjective Effects as Assessed by Score on the "Feel High" Subscale of the Drug Effects Questionnaire (DEQ) 60mg Methylphenidate	5.886486 units on a scale Standard Deviation 15.6564	9.846591 units on a scale Standard Deviation 20.80863
Subjective Effects as Assessed by Score on the "Feel High" Subscale of the Drug Effects Questionnaire (DEQ) 0mg Methylphenidate	10.39785 units on a scale Standard Deviation 17.27747	4.508671 units on a scale Standard Deviation 13.15631

SECONDARY outcome

Timeframe: 11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3

The mean score over all 44 time points is reported in this outcome measure (i.e., the summary score is reported). Each subject contributed 11 data points for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 220 data points per dose level per arm.

The VAS presents 100-mm horizontal lines labeled with an adjective: "stimulated," "high," "anxious," "elated," "hungry," and "nauseated." The "elated" subscale is reported, and this sub scale is anchored by "not at all" (0) on the left and "extremely" (100) on the right, with a score range of 0-100. The higher the score, the worse the outcome.

Outcome measures

Measure	Buspirone Plus Methylphenidate n=20 Participants \[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo\] \[week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\] \[week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\]	Placebo for Buspirone Plus Methylphenidate n=20 Participants \[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo\] \[week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\] \[week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\]
Subjective Effects as Assessed by the "Elated" Subscale of the Visual Analogue Scale (VAS) 15mg Methylphenidate	11.48128 units on a scale Standard Deviation 21.53051	19.53448 units on a scale Standard Deviation 23.74495
Subjective Effects as Assessed by the "Elated" Subscale of the Visual Analogue Scale (VAS) 30mg Methylphenidate	28.72973 units on a scale Standard Deviation 29.45967	21.42045 units on a scale Standard Deviation 25.17651
Subjective Effects as Assessed by the "Elated" Subscale of the Visual Analogue Scale (VAS) 0mg Methylphenidate	21.95676 units on a scale Standard Deviation 25.58082	14.89017 units on a scale Standard Deviation 25.46919
Subjective Effects as Assessed by the "Elated" Subscale of the Visual Analogue Scale (VAS) 60mg Methylphenidate	14.54595 units on a scale Standard Deviation 24.1708	21.81143 units on a scale Standard Deviation 27.00221

SECONDARY outcome

Timeframe: 11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3

The mean score over all 44 time points is reported in this outcome measure (i.e., the summary score is reported). Each subject contributed 11 data points for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 220 data points per dose level per arm.

Heart rate is the measure of heart beats per minute.

Outcome measures

Measure	Buspirone Plus Methylphenidate n=20 Participants \[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo\] \[week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\] \[week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\]	Placebo for Buspirone Plus Methylphenidate n=20 Participants \[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo\] \[week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\] \[week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\]
Heart Rate 15mg Methylphenidate	66.84492 beats per minute Standard Deviation 13.48406	67.75568 beats per minute Standard Deviation 14.40208
Heart Rate 30mg Methylphenidate	66.43316 beats per minute Standard Deviation 13.03261	68.26136 beats per minute Standard Deviation 12.89296
Heart Rate 60mg Methylphenidate	66.36364 beats per minute Standard Deviation 10.55586	69.13068 beats per minute Standard Deviation 13.71256
Heart Rate 0mg Methylphenidate	63.21925 beats per minute Standard Deviation 9.372807	69.60795 beats per minute Standard Deviation 12.09863

SECONDARY outcome

Timeframe: 11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3

The mean score over all 44 time points is reported in this outcome measure (i.e., the summary score is reported). Each subject contributed 11 data points for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 220 data points per dose level per arm.

Systolic blood pressure is the amount of pressure in the arteries during contraction of the heart muscle.

Outcome measures

Measure	Buspirone Plus Methylphenidate n=20 Participants \[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo\] \[week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\] \[week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\]	Placebo for Buspirone Plus Methylphenidate n=20 Participants \[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo\] \[week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\] \[week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\]
Systolic Blood Pressure 0mg Methylphenidate	114.7914 mmHg Standard Deviation 12.56828	115.6932 mmHg Standard Deviation 10.68976
Systolic Blood Pressure 15mg Methylphenidate	118.0856 mmHg Standard Deviation 11.56065	115.9205 mmHg Standard Deviation 9.891666
Systolic Blood Pressure 30mg Methylphenidate	114.8396 mmHg Standard Deviation 10.86901	120.4545 mmHg Standard Deviation 12.3153
Systolic Blood Pressure 60mg Methylphenidate	114.3904 mmHg Standard Deviation 12.69334	113.6932 mmHg Standard Deviation 10.50046

SECONDARY outcome

Timeframe: 11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3

The mean score over all 44 time points is reported in this outcome measure (i.e., the summary score is reported). Each subject contributed 11 data points for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 220 data points per dose level per arm.

Diastolic blood pressure is the blood pressure when the heart muscle is between beats.

Outcome measures

Measure	Buspirone Plus Methylphenidate n=20 Participants \[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo\] \[week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\] \[week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\]	Placebo for Buspirone Plus Methylphenidate n=20 Participants \[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo\] \[week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\] \[week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\]
Diastolic Blood Pressure 15mg Methylphenidate	74.72727 mmHg Standard Deviation 8.177168	76.71591 mmHg Standard Deviation 6.985616
Diastolic Blood Pressure 60mg Methylphenidate	73 mmHg Standard Deviation 9.153999	75.5625 mmHg Standard Deviation 7.56583
Diastolic Blood Pressure 0mg Methylphenidate	72.92513 mmHg Standard Deviation 9.052699	76.88636 mmHg Standard Deviation 7.938955
Diastolic Blood Pressure 30mg Methylphenidate	74.56684 mmHg Standard Deviation 8.160986	78.53409 mmHg Standard Deviation 8.962077

SECONDARY outcome

Timeframe: baseline

Subjects are required to respond selectively to a series of stimuli (e.g., numbers) presented briefly for 500 ms with a 500 ms intertrial interval (ITI). Increases in false alarm rates are interpreted as failures in response inhibition. Five digit numbers are presented on a computer screen every 500 ms sec. Subjects are instructed to respond when the first number of a set was repeated. A "hit" response is scored when a subject correctly responds. Distracters consist of five-digit numbers that are completely different from the first, and numbers in which four of the five digits match the original, with the non-matching number occurring randomly across the five digit places. A response to the number with 4 of 5 digits correct is scored as a "false alarm." The a-prime value reflects the ability of the participant to discriminate between signal (Go stimulus) and noise (No-Go stimulus) and ranges from 0.5 (chance level) to 1 (perfect discrimination).

Outcome measures

Measure	Buspirone Plus Methylphenidate n=20 Participants \[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo\] \[week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\] \[week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\]	Placebo for Buspirone Plus Methylphenidate n=20 Participants \[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo\] \[week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\] \[week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\]
Rapid Response Inhibition as Assessed by the Immediate Memory Task (IMT)	0.8327941 a-prime Standard Deviation 0.1418202	0.8498438 a-prime Standard Deviation 0.0854399

SECONDARY outcome

Timeframe: Thursday of week 1

Subjects are required to respond selectively to a series of stimuli (e.g., numbers) presented briefly for 500 ms with a 500 ms intertrial interval (ITI). Increases in false alarm rates are interpreted as failures in response inhibition. Five digit numbers are presented on a computer screen every 500 ms sec. Subjects are instructed to respond when the first number of a set was repeated. A "hit" response is scored when a subject correctly responds. Distracters consist of five-digit numbers that are completely different from the first, and numbers in which four of the five digits match the original, with the non-matching number occurring randomly across the five digit places. A response to the number with 4 of 5 digits correct is scored as a "false alarm." The a-prime value reflects the ability of the participant to discriminate between signal (Go stimulus) and noise (No-Go stimulus) and ranges from 0.5 (chance level) to 1 (perfect discrimination).

Outcome measures

Measure	Buspirone Plus Methylphenidate n=20 Participants \[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo\] \[week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\] \[week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\]	Placebo for Buspirone Plus Methylphenidate n=20 Participants \[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo\] \[week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\] \[week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\]
Rapid Response Inhibition as Assessed by the Immediate Memory Task (IMT)	0.8673529 a-prime Standard Deviation 0.0764632	0.8551562 a-prime Standard Deviation 0.0849648

SECONDARY outcome

Timeframe: Monday of week 4

Subjects are required to respond selectively to a series of stimuli (e.g., numbers) presented briefly for 500 ms with a 500 ms intertrial interval (ITI). Increases in false alarm rates are interpreted as failures in response inhibition. Five digit numbers are presented on a computer screen every 500 ms sec. Subjects are instructed to respond when the first number of a set was repeated. A "hit" response is scored when a subject correctly responds. Distracters consist of five-digit numbers that are completely different from the first, and numbers in which four of the five digits match the original, with the non-matching number occurring randomly across the five digit places. A response to the number with 4 of 5 digits correct is scored as a "false alarm." The a-prime value reflects the ability of the participant to discriminate between signal (Go stimulus) and noise (No-Go stimulus) and ranges from 0.5 (chance level) to 1 (perfect discrimination).

Outcome measures

Measure	Buspirone Plus Methylphenidate n=20 Participants \[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo\] \[week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\] \[week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\]	Placebo for Buspirone Plus Methylphenidate n=20 Participants \[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo\] \[week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\] \[week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\]
Rapid Response Inhibition as Assessed by the Immediate Memory Task (IMT)	0.8569118 a-prime Standard Deviation 0.0773489	0.8695347 a-prime Standard Deviation 0.0723827

SECONDARY outcome

Timeframe: baseline

The task is a rapid-presentation, probablistic gain/loss design. Reversal learning is assessed by means of a simple computerized card game. The paradigm utilizes a visual discrimination task where subjects have to learn to respond to outcome contingencies between two stimuli (high probability gain/low probability loss vs. low probability gain/high probability loss). At an unsignaled time point halfway into testing, the contingencies are reversed; the losing card becomes the winning card and the winning card becomes the losing one. Visual feedback regarding win or loss ($0.20) is provided after each trial and the cumulative total gained/lost is also shown. Using trial-and-error feedback, subjects have to discover which of the two patterns is correct and are instructed to win as much money as possible. The duration of the task is approximately 10 minutes, consisting of 80 trials.

Outcome measures

Measure	Buspirone Plus Methylphenidate n=20 Participants \[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo\] \[week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\] \[week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\]	Placebo for Buspirone Plus Methylphenidate n=20 Participants \[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo\] \[week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\] \[week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\]
Reversal Learning as Assessed by Number of Perseverative Errors on the Reversal Learning Task	14.41176 number of perseverative errors Standard Deviation 8.155204	10.625 number of perseverative errors Standard Deviation 8.023923

SECONDARY outcome

Timeframe: Thursday of week 1

The task is a rapid-presentation, probablistic gain/loss design. Reversal learning is assessed by means of a simple computerized card game. The paradigm utilizes a visual discrimination task where subjects have to learn to respond to outcome contingencies between two stimuli (high probability gain/low probability loss vs. low probability gain/high probability loss). At an unsignaled time point halfway into testing, the contingencies are reversed; the losing card becomes the winning card and the winning card becomes the losing one. Visual feedback regarding win or loss ($0.20) is provided after each trial and the cumulative total gained/lost is also shown. Using trial-and-error feedback, subjects have to discover which of the two patterns is correct and are instructed to win as much money as possible. The duration of the task is approximately 10 minutes, consisting of 80 trials.

Outcome measures

Measure	Buspirone Plus Methylphenidate n=20 Participants \[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo\] \[week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\] \[week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\]	Placebo for Buspirone Plus Methylphenidate n=20 Participants \[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo\] \[week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\] \[week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\]
Reversal Learning as Assessed by Number of Perseverative Errors on the Reversal Learning Task	11.78154 number of perseverative errors Standard Deviation 12.04489	14.13049 number of perseverative errors Standard Deviation 15.27429

SECONDARY outcome

Timeframe: Monday of week 4

The task is a rapid-presentation, probablistic gain/loss design. Reversal learning is assessed by means of a simple computerized card game. The paradigm utilizes a visual discrimination task where subjects have to learn to respond to outcome contingencies between two stimuli (high probability gain/low probability loss vs. low probability gain/high probability loss). At an unsignaled time point halfway into testing, the contingencies are reversed; the losing card becomes the winning card and the winning card becomes the losing one. Visual feedback regarding win or loss ($0.20) is provided after each trial and the cumulative total gained/lost is also shown. Using trial-and-error feedback, subjects have to discover which of the two patterns is correct and are instructed to win as much money as possible. The duration of the task is approximately 10 minutes, consisting of 80 trials.

Outcome measures

Measure	Buspirone Plus Methylphenidate n=20 Participants \[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo\] \[week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\] \[week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\]	Placebo for Buspirone Plus Methylphenidate n=20 Participants \[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo\] \[week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\] \[week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\]
Reversal Learning as Assessed by Number of Perseverative Errors on the Reversal Learning Task	10.88235 number of perseverative errors Standard Deviation 8.305739	14.69598 number of perseverative errors Standard Deviation 16.61123

Adverse Events

Buspirone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Buspirone n=20 participants at risk week 1: Buspirone 30 mg BID weeks 2-3: Buspirone 45 mg BID Buspirone: week 1 = 30 mg BID weeks 2-3 = 45 mg BID	Placebo n=20 participants at risk week 1: Placebo BID weeks 2-3: Placebo BID Placebo: week 1 = placebo BID weeks 2-3 = placebo BID
Cardiac disorders Elevated Blood pressure (transient)	0.00% 0/20 • 3 weeks	5.0% 1/20 • Number of events 1 • 3 weeks
Gastrointestinal disorders Upset stomach/nausea	0.00% 0/20 • 3 weeks	5.0% 1/20 • Number of events 1 • 3 weeks

Additional Information

Scott Lane, PhD

The University of Texas Health Science Center at Houston

Phone: 713-486-2535

Email: Scott.D.Lane@uth.tmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place