Trial Outcomes & Findings for Buspirone, Stress, and Attentional Bias to Marijuana Cues (NCT NCT02132832)

Results Overview

Eye movements are analyzed using a MiraMetrix S2 Eyetracker. This outcome measure reports a ratio: \[(number of anti-saccade errors with marijuana-related images) divided by (total number of anti-saccade errors with marijuana-related images or neutral images)\]. Anti-saccade errors are when the subject fails to inhibit fixation onto the image.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

45 participants

Primary outcome timeframe

week 1

Results posted on

2017-06-02

Participant Flow

45 were enrolled (i.e., screened and consented), but 3 participants never returned to begin the study. Thus, only 42 participants began the study.

Participant milestones

Participant milestones
Measure	Buspirone Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.	Placebo Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
Overall Study STARTED	19	23
Overall Study COMPLETED	16	16
Overall Study NOT COMPLETED	3	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Buspirone, Stress, and Attentional Bias to Marijuana Cues

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Buspirone n=19 Participants Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.	Placebo n=23 Participants Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.	Total n=42 Participants Total of all reporting groups
Age, Continuous	29.16 years STANDARD_DEVIATION 7.15 • n=99 Participants	29.52 years STANDARD_DEVIATION 6.89 • n=107 Participants	29.34 years STANDARD_DEVIATION 7.02 • n=206 Participants
Sex: Female, Male Female	8 Participants n=99 Participants	10 Participants n=107 Participants	18 Participants n=206 Participants
Sex: Female, Male Male	11 Participants n=99 Participants	13 Participants n=107 Participants	24 Participants n=206 Participants
Region of Enrollment United States	19 participants n=99 Participants	23 participants n=107 Participants	42 participants n=206 Participants

PRIMARY outcome

Timeframe: week 1

Eye movements are analyzed using a MiraMetrix S2 Eyetracker. This outcome measure reports a ratio: \[(number of anti-saccade errors with marijuana-related images) divided by (total number of anti-saccade errors with marijuana-related images or neutral images)\]. Anti-saccade errors are when the subject fails to inhibit fixation onto the image.

Outcome measures

Outcome measures
Measure	Buspirone n=16 Participants Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.	Placebo n=16 Participants Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
Attentional Bias to Marijuana Specific Stimuli Measured Via Analysis of Eye Movements	0.5795019 ratio of errors (see OM description) Standard Deviation 0.1609511	0.5539831 ratio of errors (see OM description) Standard Deviation 0.1442601

PRIMARY outcome

Timeframe: week 2

Eye movements are analyzed using a MiraMetrix S2 Eyetracker. This outcome measure reports a ratio: \[(number of anti-saccade errors with marijuana-related images) divided by (total number of anti-saccade errors with marijuana-related images or neutral images)\]. Anti-saccade errors are when the subject fails to inhibit fixation onto the image.

Outcome measures

Outcome measures
Measure	Buspirone n=16 Participants Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.	Placebo n=16 Participants Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
Attentional Bias to Marijuana Specific Stimuli Measured Via Analysis of Eye Movements	0.5517691 ratio of errors (see OM description) Standard Deviation 0.1319968	0.4979594 ratio of errors (see OM description) Standard Deviation 0.1486691

PRIMARY outcome

Timeframe: week 3

Eye movements are analyzed using a MiraMetrix S2 Eyetracker. This outcome measure reports a ratio: \[(number of anti-saccade errors with marijuana-related images) divided by (total number of anti-saccade errors with marijuana-related images or neutral images)\]. Anti-saccade errors are when the subject fails to inhibit fixation onto the image.

Outcome measures

Outcome measures
Measure	Buspirone n=16 Participants Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.	Placebo n=16 Participants Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
Attentional Bias to Marijuana Specific Stimuli Measured Via Analysis of Eye Movements	0.5503957 ratio of errors (see OM description) Standard Deviation 0.1133407	0.531073 ratio of errors (see OM description) Standard Deviation 0.1991689

PRIMARY outcome

Timeframe: week 1

The Perceived Stress Scale is a 10 item scale that was developed to measure the degree to which individuals appraise their life as stressful and has been widely used in health studies. The scale has a 5-point Likert response format. The total score is calculated by summing responses. The questions are general in nature and relatively content free with regard to specific population groups. The range of scores is 0-40, with 40 indicating the most stress.

Outcome measures

Outcome measures
Measure	Buspirone n=16 Participants Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.	Placebo n=16 Participants Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
Stress as Assessed by the Perceived Stress Scale	15.05556 units on a scale Standard Deviation 5.885898	18.57895 units on a scale Standard Deviation 6.551639

PRIMARY outcome

Timeframe: week 2

The Perceived Stress Scale is a 10 item scale that was developed to measure the degree to which individuals appraise their life as stressful and has been widely used in health studies. The scale has a 5-point Likert response format. The total score is calculated by summing responses. The questions are general in nature and relatively content free with regard to specific population groups. The range of scores is 0-40, with 40 indicating the most stress.

Outcome measures

Outcome measures
Measure	Buspirone n=16 Participants Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.	Placebo n=16 Participants Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
Stress as Assessed by the Perceived Stress Scale	13.88889 units on a scale Standard Deviation 6.434182	16.42105 units on a scale Standard Deviation 5.708822

PRIMARY outcome

Timeframe: week 3

The Perceived Stress Scale is a 10 item scale that was developed to measure the degree to which individuals appraise their life as stressful and has been widely used in health studies. The scale has a 5-point Likert response format. The total score is calculated by summing responses. The questions are general in nature and relatively content free with regard to specific population groups. The range of scores is 0-40, with 40 indicating the most stress.

Outcome measures

Outcome measures
Measure	Buspirone n=16 Participants Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.	Placebo n=16 Participants Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
Stress as Assessed by the Perceived Stress Scale	10.38889 units on a scale Standard Deviation 6.436467	14.05263 units on a scale Standard Deviation 7.799385

PRIMARY outcome

Timeframe: week 1

The Zung Self-Rated Anxiety Scale is a widely-used 20 item scale that is scored on a Likert-type scale of 1-4, with 15 questions concerning increasing anxiety levels and five questions concerning decreasing anxiety levels. The scale focuses on the most common general anxiety symptoms and means of coping with stressors that produce anxiety. The range of scores is 20-80: * 20-44 Normal Range * 45-59 Mild to Moderate Anxiety Levels * 60-74 Marked to Severe Anxiety Levels * 75-80 Extreme Anxiety Levels

Outcome measures

Outcome measures
Measure	Buspirone n=16 Participants Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.	Placebo n=16 Participants Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
Anxiety as Assessed by the Zung Self-Rated Anxiety Scale	32.44444 units on a scale Standard Deviation 2.955	32.52632 units on a scale Standard Deviation 4.880442

PRIMARY outcome

Timeframe: week 2

The Zung Self-Rated Anxiety Scale is a widely-used 20 item scale that is scored on a Likert-type scale of 1-4, with 15 questions concerning increasing anxiety levels and five questions concerning decreasing anxiety levels. The scale focuses on the most common general anxiety symptoms and means of coping with stressors that produce anxiety. The range of scores is 20-80: * 20-44 Normal Range * 45-59 Mild to Moderate Anxiety Levels * 60-74 Marked to Severe Anxiety Levels * 75-80 Extreme Anxiety Levels

Outcome measures

Outcome measures
Measure	Buspirone n=16 Participants Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.	Placebo n=16 Participants Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
Anxiety as Assessed by the Zung Self-Rated Anxiety Scale	31.5 units on a scale Standard Deviation 3.714043	31.57895 units on a scale Standard Deviation 3.79057

PRIMARY outcome

Timeframe: week 3

The Zung Self-Rated Anxiety Scale is a widely-used 20 item scale that is scored on a Likert-type scale of 1-4, with 15 questions concerning increasing anxiety levels and five questions concerning decreasing anxiety levels. The scale focuses on the most common general anxiety symptoms and means of coping with stressors that produce anxiety. The range of scores is 20-80: * 20-44 Normal Range * 45-59 Mild to Moderate Anxiety Levels * 60-74 Marked to Severe Anxiety Levels * 75-80 Extreme Anxiety Levels

Outcome measures

Outcome measures
Measure	Buspirone n=16 Participants Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.	Placebo n=16 Participants Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
Anxiety as Assessed by the Zung Self-Rated Anxiety Scale	33.27778 units on a scale Standard Deviation 4.884616	31.63158 units on a scale Standard Deviation 4.125941

PRIMARY outcome

Timeframe: week 1

With the Visual Analogue Stress Scale - Current (VASS-C), current stress level is ranked on a 0 - 10 visual analog scale, with 0 as no stress and 10 as extreme stress, cued by the question "Please rate your current stress level."

Outcome measures

Outcome measures
Measure	Buspirone n=16 Participants Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.	Placebo n=16 Participants Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
Stress as Assessed by the Visual Analogue Stress Scale-Current (VASS-C)	3.888889 units on a scale Standard Deviation 2.373602	3.631579 units on a scale Standard Deviation 3.515213

PRIMARY outcome

Timeframe: week 2

With the Visual Analogue Stress Scale - Current (VASS-C), current stress level is ranked on a 0 - 10 visual analog scale, with 0 as no stress and 10 as extreme stress, cued by the question "Please rate your current stress level."

Outcome measures

Outcome measures
Measure	Buspirone n=16 Participants Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.	Placebo n=16 Participants Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
Stress as Assessed by the Visual Analogue Stress Scale-Current (VASS-C)	3 units on a scale Standard Deviation 2.44949	2.789474 units on a scale Standard Deviation 2.636895

PRIMARY outcome

Timeframe: week 3

With the Visual Analogue Stress Scale - Current (VASS-C), current stress level is ranked on a 0 - 10 visual analog scale, with 0 as no stress and 10 as extreme stress, cued by the question "Please rate your current stress level."

Outcome measures

Outcome measures
Measure	Buspirone n=16 Participants Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.	Placebo n=16 Participants Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
Stress as Assessed by the Visual Analogue Stress Scale-Current (VASS-C)	1.944444 units on a scale Standard Deviation 1.862074	2.526316 units on a scale Standard Deviation 2.50263

Adverse Events

Buspirone

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

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

Other adverse events
Measure	Buspirone n=19 participants at risk Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.	Placebo n=23 participants at risk Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
Nervous system disorders light-headed, dizziness	5.3% 1/19 • Number of events 1 • 3 weeks National Institute on Drug Abuse (NIDA) Serious Adverse Event Tracking and Reporting System (SAETRS); side effects profile	0.00% 0/23 • 3 weeks National Institute on Drug Abuse (NIDA) Serious Adverse Event Tracking and Reporting System (SAETRS); side effects profile

Additional Information

Scott D. Lane, PhD

The University of Texas Health Science Center at Houston

Phone: (713) 486-2535

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place