Trial Outcomes & Findings for Buspirone as a Candidate Medication for Methamphetamine Abuse (NCT NCT01843205)

NCT ID: NCT01843205

Last Updated: 2018-02-07

Results Overview

The reinforcing effects of methamphetamine will be determined during placebo and buspirone treatment using a modified progressive ratio procedure in which subjects are offered the opportunity to earn previously sampled doses of methamphetamine. Each ratio completed on the task will earn 1/10th of the sampled dose.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 9 participants
• Primary outcome timeframe: One test per methamphetamine dose level per intervention for each participant over his/her approximate 25 day inpatient admission
• Results posted on: 2018-02-07

Participant Flow

Participant milestones

Measure	Placebo Then Buspirone Subjects were maintained on placebo for 7 days, then they were crossed over to 45 mg buspirone daily for 7 days.	Buspirone Then Placebo Subjects were maintained on 45 mg buspirone daily for 7 days, then they were crossed over to placebo for 7 days.
First Treatment (11 Days) STARTED	5	4
First Treatment (11 Days) COMPLETED	4	4
First Treatment (11 Days) NOT COMPLETED	1	0
Second Treatment (11 Days) STARTED	4	4
Second Treatment (11 Days) COMPLETED	4	4
Second Treatment (11 Days) NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Placebo Then Buspirone Subjects were maintained on placebo for 7 days, then they were crossed over to 45 mg buspirone daily for 7 days.	Buspirone Then Placebo Subjects were maintained on 45 mg buspirone daily for 7 days, then they were crossed over to placebo for 7 days.
First Treatment (11 Days) Withdrawal by Subject	1	0

Baseline Characteristics

Buspirone as a Candidate Medication for Methamphetamine Abuse

Baseline characteristics by cohort

Measure	Completing Participants n=8 Participants All subjects who completed the study.
Age, Continuous	40.5 years STANDARD_DEVIATION 5.7 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: One test per methamphetamine dose level per intervention for each participant over his/her approximate 25 day inpatient admission

The reinforcing effects of methamphetamine will be determined during placebo and buspirone treatment using a modified progressive ratio procedure in which subjects are offered the opportunity to earn previously sampled doses of methamphetamine. Each ratio completed on the task will earn 1/10th of the sampled dose.

Outcome measures

Measure	Placebo n=8 Participants Subjects were maintained on placebo for 7 days.	Buspirone n=8 Participants Subjects were maintained on 45 mg buspirone daily for 7 days.
Number of Methamphetamine Doses Self-Administered Placebo Methamphetamine	1.25 Number of Methamphetamine Doses Standard Error 1.25	0 Number of Methamphetamine Doses Standard Error 0
Number of Methamphetamine Doses Self-Administered 10 mg Methamphetamine	6.13 Number of Methamphetamine Doses Standard Error 1.72	4 Number of Methamphetamine Doses Standard Error 1.78
Number of Methamphetamine Doses Self-Administered 30 mg Methamphetamine	7.88 Number of Methamphetamine Doses Standard Error 1.42	7.5 Number of Methamphetamine Doses Standard Error 1.64

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Subjects completed 16 items that loaded into the Sedative Subscale of the Adjective Rating Scale. The items were rated 0-4 on a Likert-type scale and the sum for the 16 "sedative" items was summed to yield the Sedative Subscale score. The maximum score for this scale was 64, the minimum was 0. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both bupsirone and placebo conditions.

Outcome measures

Measure	Placebo n=8 Participants Subjects were maintained on placebo for 7 days.	Buspirone n=8 Participants Subjects were maintained on 45 mg buspirone daily for 7 days.
Peak Score on Sedative Subscale of the Adjective Rating Scale Placebo Methamphetamine	3.38 units on a scale Standard Error 1.66	2.75 units on a scale Standard Error 1.42
Peak Score on Sedative Subscale of the Adjective Rating Scale 10 mg Methamphetamine	3.63 units on a scale Standard Error 1.08	3.75 units on a scale Standard Error 1.33
Peak Score on Sedative Subscale of the Adjective Rating Scale 30 mg Methamphetamine	3 units on a scale Standard Error 0.96	3.25 units on a scale Standard Error 1.10

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Subjects completed 16 items that loaded into the Stimulant Subscale of the Adjective Rating Scale. The items were rated 0-4 on a Likert-type scale and the sum for the 16 "stimulant" items was summed to yield the Stimulant Subscale score. The maximum score for this scale was 64, the minimum was 0. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both bupsirone and placebo conditions.

Outcome measures

Measure	Placebo n=8 Participants Subjects were maintained on placebo for 7 days.	Buspirone n=8 Participants Subjects were maintained on 45 mg buspirone daily for 7 days.
Peak Score on Stimulant Subscale of the Adjective Rating Scale Placebo Methamphetamine	5.63 units on a scale Standard Error 1.18	7.25 units on a scale Standard Error 2.14
Peak Score on Stimulant Subscale of the Adjective Rating Scale 10 mg Methamphetamine	9.88 units on a scale Standard Error 1.59	9.25 units on a scale Standard Error 1.78
Peak Score on Stimulant Subscale of the Adjective Rating Scale 30 mg Methamphetamine	11.38 units on a scale Standard Error 1.59	13 units on a scale Standard Error 2.14

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Subjects rated their feelings of "Active, Alert, Energetic" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions.

Outcome measures

Measure	Placebo n=8 Participants Subjects were maintained on placebo for 7 days.	Buspirone n=8 Participants Subjects were maintained on 45 mg buspirone daily for 7 days.
Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale Placebo Methamphetamine	2.13 units on a scale Standard Error 1.54	8.75 units on a scale Standard Error 8.75
Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale 10 mg Methamphetamine	19 units on a scale Standard Error 9.51	14.5 units on a scale Standard Error 10.36
Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale 30 mg Methamphetamine	35 units on a scale Standard Error 11.25	29.25 units on a scale Standard Error 10.30

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Subjects rated their feelings of "Any Effect" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions.

Outcome measures

Measure	Placebo n=8 Participants Subjects were maintained on placebo for 7 days.	Buspirone n=8 Participants Subjects were maintained on 45 mg buspirone daily for 7 days.
Peak Ratings of "Any Effect" on the Visual Analog Scale Placebo Methamphetamine	0.75 units on a scale Standard Error 0.49	10 units on a scale Standard Error 9.12
Peak Ratings of "Any Effect" on the Visual Analog Scale 10 mg Methamphetamine	25.75 units on a scale Standard Error 8.25	21.5 units on a scale Standard Error 8.35
Peak Ratings of "Any Effect" on the Visual Analog Scale 30 mg Methamphetamine	34.38 units on a scale Standard Error 11.51	33 units on a scale Standard Error 10.04

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Subjects rated their feelings of "Bad Effects" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions.

Outcome measures

Measure	Placebo n=8 Participants Subjects were maintained on placebo for 7 days.	Buspirone n=8 Participants Subjects were maintained on 45 mg buspirone daily for 7 days.
Peak Ratings of "Bad Effects" on the Visual Analog Scale Placebo Methamphetamine	0.13 units on a scale Standard Error 0.13	1.5 units on a scale Standard Error 1.5
Peak Ratings of "Bad Effects" on the Visual Analog Scale 10 mg Methamphetamine	7 units on a scale Standard Error 6.45	7.63 units on a scale Standard Error 4.04
Peak Ratings of "Bad Effects" on the Visual Analog Scale 30 mg Methamphetamine	3.13 units on a scale Standard Error 3.13	8.38 units on a scale Standard Error 4.00

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Subjects rated their feelings of "Euphoric" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions.

Outcome measures

Measure	Placebo n=8 Participants Subjects were maintained on placebo for 7 days.	Buspirone n=8 Participants Subjects were maintained on 45 mg buspirone daily for 7 days.
Peak Ratings of "Euphoric" on the Visual Analog Scale Placebo Methamphetamine	0.63 units on a scale Standard Error 0.63	0 units on a scale Standard Error 0
Peak Ratings of "Euphoric" on the Visual Analog Scale 10 mg Methamphetamine	4.88 units on a scale Standard Error 2.41	3.88 units on a scale Standard Error 2.81
Peak Ratings of "Euphoric" on the Visual Analog Scale 30 mg Methamphetamine	7.63 units on a scale Standard Error 4.31	8.5 units on a scale Standard Error 4.78

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Subjects rated their feelings of "Good Effects" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions.

Outcome measures

Measure	Placebo n=8 Participants Subjects were maintained on placebo for 7 days.	Buspirone n=8 Participants Subjects were maintained on 45 mg buspirone daily for 7 days.
Peak Ratings of "Good Effects" on the Visual Analog Scale 30 mg Methamphetamine	30.63 units on a scale Standard Error 12.04	31.5 units on a scale Standard Error 10.82
Peak Ratings of "Good Effects" on the Visual Analog Scale Placebo Methamphetamine	0.88 units on a scale Standard Error 0.64	9.63 units on a scale Standard Error 9.34
Peak Ratings of "Good Effects" on the Visual Analog Scale 10 mg Methamphetamine	21 units on a scale Standard Error 9.01	17.38 units on a scale Standard Error 10.36

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Subjects rated their feelings of "High" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions.

Outcome measures

Measure	Placebo n=8 Participants Subjects were maintained on placebo for 7 days.	Buspirone n=8 Participants Subjects were maintained on 45 mg buspirone daily for 7 days.
Peak Ratings of "High" on the Visual Analog Scale Placebo Methamphetamine	0.63 units on a scale Standard Error 0.63	10.5 units on a scale Standard Error 9.66
Peak Ratings of "High" on the Visual Analog Scale 10 mg Methamphetamine	22.13 units on a scale Standard Error 8.71	16.5 units on a scale Standard Error 10.51
Peak Ratings of "High" on the Visual Analog Scale 30 mg Methamphetamine	28.63 units on a scale Standard Error 10.80	31 units on a scale Standard Error 11.28

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Subjects rated their feelings of "Irregular/Racing Heartbeat" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions.

Outcome measures

Measure	Placebo n=8 Participants Subjects were maintained on placebo for 7 days.	Buspirone n=8 Participants Subjects were maintained on 45 mg buspirone daily for 7 days.
Peak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog Scale Placebo Methamphetamine	0.75 units on a scale Standard Error 0.75	8.5 units on a scale Standard Error 8.5
Peak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog Scale 10 mg Methamphetamine	10.63 units on a scale Standard Error 10.34	10.75 units on a scale Standard Error 9.92
Peak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog Scale 30 mg Methamphetamine	14.38 units on a scale Standard Error 11.33	16.13 units on a scale Standard Error 11.54

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Subjects rated their feelings of "Like Drug" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions.

Outcome measures

Measure	Placebo n=8 Participants Subjects were maintained on placebo for 7 days.	Buspirone n=8 Participants Subjects were maintained on 45 mg buspirone daily for 7 days.
Peak Ratings of "Like Drug" on the Visual Analog Scale Placebo Methamphetamine	0.63 units on a scale Standard Error 0.63	9.63 units on a scale Standard Error 9.48
Peak Ratings of "Like Drug" on the Visual Analog Scale 10 mg Methamphetamine	22.63 units on a scale Standard Error 8.87	18.50 units on a scale Standard Error 10.77
Peak Ratings of "Like Drug" on the Visual Analog Scale 30 mg Methamphetamine	32.75 units on a scale Standard Error 11.82	30.50 units on a scale Standard Error 11.16

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Subjects rated their feelings of "Nauseous" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions.

Outcome measures

Measure	Placebo n=8 Participants Subjects were maintained on placebo for 7 days.	Buspirone n=8 Participants Subjects were maintained on 45 mg buspirone daily for 7 days.
Peak Ratings of "Nauseous" on the Visual Analog Scale Placebo Methamphetamine	0 units on a scale Standard Error 0	0 units on a scale Standard Error 0
Peak Ratings of "Nauseous" on the Visual Analog Scale 10 mg Methamphetamine	6.38 units on a scale Standard Error 5.14	2.38 units on a scale Standard Error 2.38
Peak Ratings of "Nauseous" on the Visual Analog Scale 30 mg Methamphetamine	3.50 units on a scale Standard Error 2.50	5 units on a scale Standard Error 3.81

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Subjects rated their feelings of "Nervous/Anxious" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions.

Outcome measures

Measure	Placebo n=8 Participants Subjects were maintained on placebo for 7 days.	Buspirone n=8 Participants Subjects were maintained on 45 mg buspirone daily for 7 days.
Peak Ratings of "Nervous/Anxious" on the Visual Analog Scale Placebo Methamphetamine	0.88 units on a scale Standard Error 0.88	0 units on a scale Standard Error 0
Peak Ratings of "Nervous/Anxious" on the Visual Analog Scale 10 mg Methamphetamine	2.38 units on a scale Standard Error 1.69	1 units on a scale Standard Error 0.63
Peak Ratings of "Nervous/Anxious" on the Visual Analog Scale 30 mg Methamphetamine	4 units on a scale Standard Error 1.84	3.75 units on a scale Standard Error 2.66

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Subjects rated their feelings of "Willing to Pay For" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions.

Outcome measures

Measure	Placebo n=8 Participants Subjects were maintained on placebo for 7 days.	Buspirone n=8 Participants Subjects were maintained on 45 mg buspirone daily for 7 days.
Peak Ratings of "Willing to Pay For" on the Visual Analog Scale Placebo Methamphetamine	1.63 units on a scale Standard Error 1.49	9.38 units on a scale Standard Error 8.82
Peak Ratings of "Willing to Pay For" on the Visual Analog Scale 10 mg Methamphetamine	19.88 units on a scale Standard Error 9.65	17.75 units on a scale Standard Error 10.18
Peak Ratings of "Willing to Pay For" on the Visual Analog Scale 30 mg Methamphetamine	34.00 units on a scale Standard Error 11.78	31.63 units on a scale Standard Error 10.99

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Subjects rated their feelings of "Performance Impaired" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions.

Outcome measures

Measure	Placebo n=8 Participants Subjects were maintained on placebo for 7 days.	Buspirone n=8 Participants Subjects were maintained on 45 mg buspirone daily for 7 days.
Peak Ratings of "Performance Impaired" on the Visual Analog Scale Placebo Methamphetamine	0.25 units on a scale Standard Error 0.25	0 units on a scale Standard Error 0
Peak Ratings of "Performance Impaired" on the Visual Analog Scale 10 mg Methamphetamine	2.13 units on a scale Standard Error 1.54	0 units on a scale Standard Error 0
Peak Ratings of "Performance Impaired" on the Visual Analog Scale 30 mg Methamphetamine	0 units on a scale Standard Error 0	1.38 units on a scale Standard Error 1.12

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Subjects rated their feelings of "Performance Improved" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions.

Outcome measures

Measure	Placebo n=8 Participants Subjects were maintained on placebo for 7 days.	Buspirone n=8 Participants Subjects were maintained on 45 mg buspirone daily for 7 days.
Peak Ratings of "Performance Improved" on the Visual Analog Scale Placebo Methamphetamine	0 units on a scale Standard Error 0	9.25 units on a scale Standard Error 9.11
Peak Ratings of "Performance Improved" on the Visual Analog Scale 10 mg Methamphetamine	15 units on a scale Standard Error 9.32	13.38 units on a scale Standard Error 10.60
Peak Ratings of "Performance Improved" on the Visual Analog Scale 30 mg Methamphetamine	19.13 units on a scale Standard Error 12.24	22.75 units on a scale Standard Error 12.07

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Subjects rated their feelings of "Restless" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions.

Outcome measures

Measure	Placebo n=8 Participants Subjects were maintained on placebo for 7 days.	Buspirone n=8 Participants Subjects were maintained on 45 mg buspirone daily for 7 days.
Peak Ratings of "Restless" on the Visual Analog Scale Placebo Methamphetamine	5 units on a scale Standard Error 5	0 units on a scale Standard Error 0
Peak Ratings of "Restless" on the Visual Analog Scale 10 mg Methamphetamine	3.13 units on a scale Standard Error 1.67	0.50 units on a scale Standard Error 0.50
Peak Ratings of "Restless" on the Visual Analog Scale 30 mg Methamphetamine	0.25 units on a scale Standard Error 0.25	1.13 units on a scale Standard Error 0.58

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Subjects rated their feelings of "Rush" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions.

Outcome measures

Measure	Placebo n=8 Participants Subjects were maintained on placebo for 7 days.	Buspirone n=8 Participants Subjects were maintained on 45 mg buspirone daily for 7 days.
Peak Ratings of "Rush" on the Visual Analog Scale Placebo Methamphetamine	0.13 units on a scale Standard Error 0.13	10.25 units on a scale Standard Error 9.97
Peak Ratings of "Rush" on the Visual Analog Scale 10 mg Methamphetamine	21.63 units on a scale Standard Error 8.28	16.50 units on a scale Standard Error 10.57
Peak Ratings of "Rush" on the Visual Analog Scale 30 mg Methamphetamine	21.75 units on a scale Standard Error 11.04	26.13 units on a scale Standard Error 11.14

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Subjects rated their feelings of "Shaky/Jittery" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions.

Outcome measures

Measure	Placebo n=8 Participants Subjects were maintained on placebo for 7 days.	Buspirone n=8 Participants Subjects were maintained on 45 mg buspirone daily for 7 days.
Peak Ratings of "Shaky/Jittery" on the Visual Analog Scale Placebo Methamphetamine	0.13 units on a scale Standard Error 0.13	8.38 units on a scale Standard Error 7.69
Peak Ratings of "Shaky/Jittery" on the Visual Analog Scale 10 mg Methamphetamine	1.88 units on a scale Standard Error 1.32	0.75 units on a scale Standard Error 0.53
Peak Ratings of "Shaky/Jittery" on the Visual Analog Scale 30 mg Methamphetamine	2.88 units on a scale Standard Error 1.90	5.50 units on a scale Standard Error 2.33

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Subjects rated their feelings of "Sluggish/Fatigued/Lazy" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions.

Outcome measures

Measure	Placebo n=8 Participants Subjects were maintained on placebo for 7 days.	Buspirone n=8 Participants Subjects were maintained on 45 mg buspirone daily for 7 days.
Peak Ratings of "Sluggish/Fatigued/Lazy" on the Visual Analog Scale Placebo Methamphetamine	1.5 units on a scale Standard Error 1.5	0 units on a scale Standard Error 0
Peak Ratings of "Sluggish/Fatigued/Lazy" on the Visual Analog Scale 10 mg Methamphetamine	1.88 units on a scale Standard Error 1.49	2.88 units on a scale Standard Error 1.99
Peak Ratings of "Sluggish/Fatigued/Lazy" on the Visual Analog Scale 30 mg Methamphetamine	3.13 units on a scale Standard Error 2.60	2.25 units on a scale Standard Error 2.25

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Subjects rated their feelings of "Stimulated" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions.

Outcome measures

Measure	Placebo n=8 Participants Subjects were maintained on placebo for 7 days.	Buspirone n=8 Participants Subjects were maintained on 45 mg buspirone daily for 7 days.
Peak Ratings of "Stimulated" on the Visual Analog Scale Placebo Methamphetamine	1.25 units on a scale Standard Error 0.77	9.88 units on a scale Standard Error 9.31
Peak Ratings of "Stimulated" on the Visual Analog Scale 10 mg Methamphetamine	21.88 units on a scale Standard Error 8.86	17.88 units on a scale Standard Error 10.81
Peak Ratings of "Stimulated" on the Visual Analog Scale 30 mg Methamphetamine	21.50 units on a scale Standard Error 11.25	24.25 units on a scale Standard Error 11.23

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Subjects rated their feelings of "Willing to Take Again" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions.

Outcome measures

Measure	Placebo n=8 Participants Subjects were maintained on placebo for 7 days.	Buspirone n=8 Participants Subjects were maintained on 45 mg buspirone daily for 7 days.
Peak Ratings of "Willing to Take Again" on the Visual Analog Scale Placebo Methamphetamine	1.25 units on a scale Standard Error 1.11	9.62 units on a scale Standard Error 9.34
Peak Ratings of "Willing to Take Again" on the Visual Analog Scale 10 mg Methamphetamine	22.00 units on a scale Standard Error 9.03	20.63 units on a scale Standard Error 10.25
Peak Ratings of "Willing to Take Again" on the Visual Analog Scale 30 mg Methamphetamine	35.00 units on a scale Standard Error 12.28	33.00 units on a scale Standard Error 10.62

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Subjects rated their feelings of "Talkative/Friendly" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions.

Outcome measures

Measure	Placebo n=8 Participants Subjects were maintained on placebo for 7 days.	Buspirone n=8 Participants Subjects were maintained on 45 mg buspirone daily for 7 days.
Peak Ratings of "Talkative/Friendly" on the Visual Analog Scale Placebo Methamphetamine	0 units on a scale Standard Error 0	9.25 units on a scale Standard Error 8.69
Peak Ratings of "Talkative/Friendly" on the Visual Analog Scale 10 mg Methamphetamine	18.50 units on a scale Standard Error 10.10	13.75 units on a scale Standard Error 9.76
Peak Ratings of "Talkative/Friendly" on the Visual Analog Scale 30 mg Methamphetamine	26.00 units on a scale Standard Error 10.48	27.25 units on a scale Standard Error 10.24

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Diastolic blood pressure was measured with an automated monitor. Higher values represent greater diastolic pressure. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions.

Outcome measures

Measure	Placebo n=8 Participants Subjects were maintained on placebo for 7 days.	Buspirone n=8 Participants Subjects were maintained on 45 mg buspirone daily for 7 days.
Peak Diastolic Blood Pressure Placebo Methamphetamine	77.50 mm Hg Standard Error 2.27	80.13 mm Hg Standard Error 3.93
Peak Diastolic Blood Pressure 10 mg Methamphetamine	80.75 mm Hg Standard Error 2.52	83.00 mm Hg Standard Error 3.94
Peak Diastolic Blood Pressure 30 mg Methamphetamine	83.80 mm Hg Standard Error 2.25	84.50 mm Hg Standard Error 2.95

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Systolic blood pressure was measured with an automated monitor. Higher values represent greater systolic pressure. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions.

Outcome measures

Measure	Placebo n=8 Participants Subjects were maintained on placebo for 7 days.	Buspirone n=8 Participants Subjects were maintained on 45 mg buspirone daily for 7 days.
Peak Systolic Blood Pressure Placebo Methamphetamine	125.38 mm Hg Standard Error 3.84	125.00 mm Hg Standard Error 2.68
Peak Systolic Blood Pressure 10 mg Methamphetamine	131.25 mm Hg Standard Error 3.71	131.63 mm Hg Standard Error 3.72
Peak Systolic Blood Pressure 30 mg Methamphetamine	139.63 mm Hg Standard Error 4.18	137.13 mm Hg Standard Error 2.57

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Heart rate was measured with an automated monitor. Higher values represent greater heart rate. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions.

Outcome measures

Measure	Placebo n=8 Participants Subjects were maintained on placebo for 7 days.	Buspirone n=8 Participants Subjects were maintained on 45 mg buspirone daily for 7 days.
Peak Heart Rate Placebo Methamphetamine	82.75 beats per minute Standard Error 6.65	81.25 beats per minute Standard Error 2.69
Peak Heart Rate 10 mg Methamphetamine	86.13 beats per minute Standard Error 3.27	85.13 beats per minute Standard Error 5.00
Peak Heart Rate 30 mg Methamphetamine	85.38 beats per minute Standard Error 5.90	90.63 beats per minute Standard Error 3.89

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Oral temperature was measured with an automated monitor. Higher values represent greater temperature. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions.

Outcome measures

Measure	Placebo n=8 Participants Subjects were maintained on placebo for 7 days.	Buspirone n=8 Participants Subjects were maintained on 45 mg buspirone daily for 7 days.
Peak Temperature Placebo Methamphetamine	98.48 degrees Fahrenheit Standard Error 0.07	98.41 degrees Fahrenheit Standard Error 0.08
Peak Temperature 10 mg Methamphetamine	98.44 degrees Fahrenheit Standard Error 0.10	98.46 degrees Fahrenheit Standard Error 0.05
Peak Temperature 30 mg Methamphetamine	98.33 degrees Fahrenheit Standard Error 0.07	98.43 degrees Fahrenheit Standard Error 0.05

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Buspirone

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

Craig R. Rush, Ph.D.

University of Kentucky

Phone: (859) 257-5388

Email: crush2@email.uky.edu

Results disclosure agreements

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