Buspirone as a Candidate Medication for Methamphetamine Abuse

• Sponsor: University of Kentucky (Other)
• Overall Status: Completed
• CT.gov ID: NCT01843205
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 9
• Location: 1
• Arms: 2
• Duration (Months): 47
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

Methamphetamine use disorders are an unrelenting public health concern. Intensive research efforts have yielded behavioral interventions that reduce methamphetamine use, however, these interventions are not universally effective and treatment effects diminish over time. Development of a pharmacotherapy that enhances the efficacy of these interventions is a priority for the National Institute on Drug Abuse. This study proposes to determine the impact of buspirone maintenance on self-administration of methamphetamine. These preliminary data will be used to support further research developing buspirone as a pharmacotherapy for methamphetamine use disorders. The investigators hypothesize that buspirone will attenuate the reinforcing effects of methamphetamine.

Condition or Disease	Intervention/Treatment	Phase
Methamphetamine Dependence; Methamphetamine Abuse	Drug: Methamphetamine; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Buspirone as a Candidate Medication for Methamphetamine Abuse
• Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: Mar 1, 2017
• Actual Study Completion Date: Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Subjects will be maintained on placebo.	Drug: Methamphetamine; The pharmacodynamic effects of methamphetamine will be determined during placebo and buspirone maintenance.; Drug: Placebo; The pharmacodynamic effects of placebo methamphetamine will be determined during placebo and buspirone maintenance.
Experimental: Buspirone Subjects will be maintained on buspirone.	Drug: Methamphetamine; The pharmacodynamic effects of methamphetamine will be determined during placebo and buspirone maintenance.; Drug: Placebo; The pharmacodynamic effects of placebo methamphetamine will be determined during placebo and buspirone maintenance.

Outcome Measures

Primary Outcome Measures

1. Number of Methamphetamine Doses Self-Administered [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.

Secondary Outcome Measures

1. Peak Score on Sedative Subscale of the Adjective Rating Scale [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.

2. Peak Score on Stimulant Subscale of the Adjective Rating Scale [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.

3. Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale [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.

4. Peak Ratings of "Any Effect" on the Visual Analog Scale [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.

5. Peak Ratings of "Bad Effects" on the Visual Analog Scale [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.

6. Peak Ratings of "Euphoric" on the Visual Analog Scale [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.

7. Peak Ratings of "Good Effects" on the Visual Analog Scale [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.

8. Peak Ratings of "High" on the Visual Analog Scale [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.

9. Peak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog Scale [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.

10. Peak Ratings of "Like Drug" on the Visual Analog Scale [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.

11. Peak Ratings of "Nauseous" on the Visual Analog Scale [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.

12. Peak Ratings of "Nervous/Anxious" on the Visual Analog Scale [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.

13. Peak Ratings of "Willing to Pay For" on the Visual Analog Scale [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.

14. Peak Ratings of "Performance Impaired" on the Visual Analog Scale [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.

15. Peak Ratings of "Performance Improved" on the Visual Analog Scale [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.

16. Peak Ratings of "Restless" on the Visual Analog Scale [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.

17. Peak Ratings of "Rush" on the Visual Analog Scale [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.

18. Peak Ratings of "Shaky/Jittery" on the Visual Analog Scale [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.

19. Peak Ratings of "Sluggish/Fatigued/Lazy" on the Visual Analog Scale [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.

20. Peak Ratings of "Stimulated" on the Visual Analog Scale [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.

21. Peak Ratings of "Willing to Take Again" on the Visual Analog Scale [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.

22. Peak Ratings of "Talkative/Friendly" on the Visual Analog Scale [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.

23. Peak Diastolic Blood Pressure [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.

24. Peak Systolic Blood Pressure [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.

25. Peak Heart Rate [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.

26. Peak Temperature [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Lifetime methamphetamine use

Exclusion Criteria:

• Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant

• Current or past histories of substance abuse or dependence that are deemed by the study physicians to interfere with study completion

• History of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation

• Females not currently using effective birth control

• Contraindications to methamphetamine or buspirone

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kentucky Medical Center	Lexington	Kentucky	United States	40536

Sponsors and Collaborators

• University of Kentucky
• National Institute on Drug Abuse (NIDA)

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 23, 2017

More Information

Publications

None provided.

• Responsible Party: Craig Rush, Professor, University of Kentucky
• ClinicalTrials.gov Identifier: NCT01843205
• Other Study ID Numbers: R21DA035481; R21DA035481
• First Posted: Apr 30, 2013
• Last Update Posted: Feb 7, 2018
• Last Verified: Jan 1, 2018

• Additional relevant MeSH terms: Methamphetamine

Study Results

Participant Flow

Arm/Group Title	Placebo Then Buspirone	Buspirone Then Placebo
Arm/Group Description	Subjects were maintained on placebo for 7 days, then they were crossed over to 45 mg buspirone daily for 7 days.	Subjects were maintained on 45 mg buspirone daily for 7 days, then they were crossed over to placebo for 7 days.
Period Title: First Treatment (11 Days)
STARTED	5	4
COMPLETED	4	4
NOT COMPLETED	1	0
Period Title: First Treatment (11 Days)
STARTED	4	4
COMPLETED	4	4
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Completing Participants
Arm/Group Description	All subjects who completed the study.
Overall Participants	8
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40.5 (5.7)
Sex: Female, Male (Count of Participants)
Female	1 12.5%
Male	7 87.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 12.5%
Not Hispanic or Latino	7 87.5%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	3 37.5%
White	3 37.5%
More than one race	2 25%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	8 100%

Outcome Measures

1. Primary Outcome

Title	Number of Methamphetamine Doses Self-Administered
Description	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.
Time Frame	One test per methamphetamine dose level per intervention for each participant over his/her approximate 25 day inpatient admission

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Buspirone
Arm/Group Description	Subjects were maintained on placebo for 7 days.	Subjects were maintained on 45 mg buspirone daily for 7 days.
Measure Participants	8	8
Placebo Methamphetamine	1.25 (1.25)	0 (0)
10 mg Methamphetamine	6.13 (1.72)	4 (1.78)
30 mg Methamphetamine	7.88 (1.42)	7.5 (1.64)

2. Secondary Outcome

Title	Peak Score on Sedative Subscale of the Adjective Rating Scale
Description	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.
Time Frame	Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Buspirone
Arm/Group Description	Subjects were maintained on placebo for 7 days.	Subjects were maintained on 45 mg buspirone daily for 7 days.
Measure Participants	8	8
Placebo Methamphetamine	3.38 (1.66)	2.75 (1.42)
10 mg Methamphetamine	3.63 (1.08)	3.75 (1.33)
30 mg Methamphetamine	3 (0.96)	3.25 (1.10)

3. Secondary Outcome

Title	Peak Score on Stimulant Subscale of the Adjective Rating Scale
Description	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.
Time Frame	Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Buspirone
Arm/Group Description	Subjects were maintained on placebo for 7 days.	Subjects were maintained on 45 mg buspirone daily for 7 days.
Measure Participants	8	8
Placebo Methamphetamine	5.63 (1.18)	7.25 (2.14)
10 mg Methamphetamine	9.88 (1.59)	9.25 (1.78)
30 mg Methamphetamine	11.38 (1.59)	13 (2.14)

4. Secondary Outcome

Title	Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale
Description	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.
Time Frame	Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Buspirone
Arm/Group Description	Subjects were maintained on placebo for 7 days.	Subjects were maintained on 45 mg buspirone daily for 7 days.
Measure Participants	8	8
Placebo Methamphetamine	2.13 (1.54)	8.75 (8.75)
10 mg Methamphetamine	19 (9.51)	14.5 (10.36)
30 mg Methamphetamine	35 (11.25)	29.25 (10.30)

5. Secondary Outcome

Title	Peak Ratings of "Any Effect" on the Visual Analog Scale
Description	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.
Time Frame	Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Buspirone
Arm/Group Description	Subjects were maintained on placebo for 7 days.	Subjects were maintained on 45 mg buspirone daily for 7 days.
Measure Participants	8	8
Placebo Methamphetamine	0.75 (0.49)	10 (9.12)
10 mg Methamphetamine	25.75 (8.25)	21.5 (8.35)
30 mg Methamphetamine	34.38 (11.51)	33 (10.04)

6. Secondary Outcome

Title	Peak Ratings of "Bad Effects" on the Visual Analog Scale
Description	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.
Time Frame	Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Buspirone
Arm/Group Description	Subjects were maintained on placebo for 7 days.	Subjects were maintained on 45 mg buspirone daily for 7 days.
Measure Participants	8	8
Placebo Methamphetamine	0.13 (0.13)	1.5 (1.5)
10 mg Methamphetamine	7 (6.45)	7.63 (4.04)
30 mg Methamphetamine	3.13 (3.13)	8.38 (4.00)

7. Secondary Outcome

Title	Peak Ratings of "Euphoric" on the Visual Analog Scale
Description	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.
Time Frame	Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Buspirone
Arm/Group Description	Subjects were maintained on placebo for 7 days.	Subjects were maintained on 45 mg buspirone daily for 7 days.
Measure Participants	8	8
Placebo Methamphetamine	0.63 (0.63)	0 (0)
10 mg Methamphetamine	4.88 (2.41)	3.88 (2.81)
30 mg Methamphetamine	7.63 (4.31)	8.5 (4.78)

8. Secondary Outcome

Title	Peak Ratings of "Good Effects" on the Visual Analog Scale
Description	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.
Time Frame	Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Buspirone
Arm/Group Description	Subjects were maintained on placebo for 7 days.	Subjects were maintained on 45 mg buspirone daily for 7 days.
Measure Participants	8	8
Placebo Methamphetamine	0.88 (0.64)	9.63 (9.34)
10 mg Methamphetamine	21 (9.01)	17.38 (10.36)
30 mg Methamphetamine	30.63 (12.04)	31.5 (10.82)

9. Secondary Outcome

Title	Peak Ratings of "High" on the Visual Analog Scale
Description	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.
Time Frame	Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Buspirone
Arm/Group Description	Subjects were maintained on placebo for 7 days.	Subjects were maintained on 45 mg buspirone daily for 7 days.
Measure Participants	8	8
Placebo Methamphetamine	0.63 (0.63)	10.5 (9.66)
10 mg Methamphetamine	22.13 (8.71)	16.5 (10.51)
30 mg Methamphetamine	28.63 (10.80)	31 (11.28)

10. Secondary Outcome

Title	Peak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog Scale
Description	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.
Time Frame	Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Buspirone
Arm/Group Description	Subjects were maintained on placebo for 7 days.	Subjects were maintained on 45 mg buspirone daily for 7 days.
Measure Participants	8	8
Placebo Methamphetamine	0.75 (0.75)	8.5 (8.5)
10 mg Methamphetamine	10.63 (10.34)	10.75 (9.92)
30 mg Methamphetamine	14.38 (11.33)	16.13 (11.54)

11. Secondary Outcome

Title	Peak Ratings of "Like Drug" on the Visual Analog Scale
Description	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.
Time Frame	Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Buspirone
Arm/Group Description	Subjects were maintained on placebo for 7 days.	Subjects were maintained on 45 mg buspirone daily for 7 days.
Measure Participants	8	8
Placebo Methamphetamine	0.63 (0.63)	9.63 (9.48)
10 mg Methamphetamine	22.63 (8.87)	18.50 (10.77)
30 mg Methamphetamine	32.75 (11.82)	30.50 (11.16)

12. Secondary Outcome

Title	Peak Ratings of "Nauseous" on the Visual Analog Scale
Description	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.
Time Frame	Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Buspirone
Arm/Group Description	Subjects were maintained on placebo for 7 days.	Subjects were maintained on 45 mg buspirone daily for 7 days.
Measure Participants	8	8
Placebo Methamphetamine	0 (0)	0 (0)
10 mg Methamphetamine	6.38 (5.14)	2.38 (2.38)
30 mg Methamphetamine	3.50 (2.50)	5 (3.81)

13. Secondary Outcome

Title	Peak Ratings of "Nervous/Anxious" on the Visual Analog Scale
Description	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.
Time Frame	Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Buspirone
Arm/Group Description	Subjects were maintained on placebo for 7 days.	Subjects were maintained on 45 mg buspirone daily for 7 days.
Measure Participants	8	8
Placebo Methamphetamine	0.88 (0.88)	0 (0)
10 mg Methamphetamine	2.38 (1.69)	1 (0.63)
30 mg Methamphetamine	4 (1.84)	3.75 (2.66)

14. Secondary Outcome

Title	Peak Ratings of "Willing to Pay For" on the Visual Analog Scale
Description	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.
Time Frame	Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Buspirone
Arm/Group Description	Subjects were maintained on placebo for 7 days.	Subjects were maintained on 45 mg buspirone daily for 7 days.
Measure Participants	8	8
Placebo Methamphetamine	1.63 (1.49)	9.38 (8.82)
10 mg Methamphetamine	19.88 (9.65)	17.75 (10.18)
30 mg Methamphetamine	34.00 (11.78)	31.63 (10.99)

15. Secondary Outcome

Title	Peak Ratings of "Performance Impaired" on the Visual Analog Scale
Description	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.
Time Frame	Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Buspirone
Arm/Group Description	Subjects were maintained on placebo for 7 days.	Subjects were maintained on 45 mg buspirone daily for 7 days.
Measure Participants	8	8
Placebo Methamphetamine	0.25 (0.25)	0 (0)
10 mg Methamphetamine	2.13 (1.54)	0 (0)
30 mg Methamphetamine	0 (0)	1.38 (1.12)

16. Secondary Outcome

Title	Peak Ratings of "Performance Improved" on the Visual Analog Scale
Description	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.
Time Frame	Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Buspirone
Arm/Group Description	Subjects were maintained on placebo for 7 days.	Subjects were maintained on 45 mg buspirone daily for 7 days.
Measure Participants	8	8
Placebo Methamphetamine	0 (0)	9.25 (9.11)
10 mg Methamphetamine	15 (9.32)	13.38 (10.60)
30 mg Methamphetamine	19.13 (12.24)	22.75 (12.07)

17. Secondary Outcome

Title	Peak Ratings of "Restless" on the Visual Analog Scale
Description	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.
Time Frame	Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Buspirone
Arm/Group Description	Subjects were maintained on placebo for 7 days.	Subjects were maintained on 45 mg buspirone daily for 7 days.
Measure Participants	8	8
Placebo Methamphetamine	5 (5)	0 (0)
10 mg Methamphetamine	3.13 (1.67)	0.50 (0.50)
30 mg Methamphetamine	0.25 (0.25)	1.13 (0.58)

18. Secondary Outcome

Title	Peak Ratings of "Rush" on the Visual Analog Scale
Description	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.
Time Frame	Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Buspirone
Arm/Group Description	Subjects were maintained on placebo for 7 days.	Subjects were maintained on 45 mg buspirone daily for 7 days.
Measure Participants	8	8
Placebo Methamphetamine	0.13 (0.13)	10.25 (9.97)
10 mg Methamphetamine	21.63 (8.28)	16.50 (10.57)
30 mg Methamphetamine	21.75 (11.04)	26.13 (11.14)

19. Secondary Outcome

Title	Peak Ratings of "Shaky/Jittery" on the Visual Analog Scale
Description	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.
Time Frame	Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Buspirone
Arm/Group Description	Subjects were maintained on placebo for 7 days.	Subjects were maintained on 45 mg buspirone daily for 7 days.
Measure Participants	8	8
Placebo Methamphetamine	0.13 (0.13)	8.38 (7.69)
10 mg Methamphetamine	1.88 (1.32)	0.75 (0.53)
30 mg Methamphetamine	2.88 (1.90)	5.50 (2.33)

20. Secondary Outcome

Title	Peak Ratings of "Sluggish/Fatigued/Lazy" on the Visual Analog Scale
Description	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.
Time Frame	Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Buspirone
Arm/Group Description	Subjects were maintained on placebo for 7 days.	Subjects were maintained on 45 mg buspirone daily for 7 days.
Measure Participants	8	8
Placebo Methamphetamine	1.5 (1.5)	0 (0)
10 mg Methamphetamine	1.88 (1.49)	2.88 (1.99)
30 mg Methamphetamine	3.13 (2.60)	2.25 (2.25)

21. Secondary Outcome

Title	Peak Ratings of "Stimulated" on the Visual Analog Scale
Description	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.
Time Frame	Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Buspirone
Arm/Group Description	Subjects were maintained on placebo for 7 days.	Subjects were maintained on 45 mg buspirone daily for 7 days.
Measure Participants	8	8
Placebo Methamphetamine	1.25 (0.77)	9.88 (9.31)
10 mg Methamphetamine	21.88 (8.86)	17.88 (10.81)
30 mg Methamphetamine	21.50 (11.25)	24.25 (11.23)

22. Secondary Outcome

Title	Peak Ratings of "Willing to Take Again" on the Visual Analog Scale
Description	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.
Time Frame	Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Buspirone
Arm/Group Description	Subjects were maintained on placebo for 7 days.	Subjects were maintained on 45 mg buspirone daily for 7 days.
Measure Participants	8	8
Placebo Methamphetamine	1.25 (1.11)	9.62 (9.34)
10 mg Methamphetamine	22.00 (9.03)	20.63 (10.25)
30 mg Methamphetamine	35.00 (12.28)	33.00 (10.62)

23. Secondary Outcome

Title	Peak Ratings of "Talkative/Friendly" on the Visual Analog Scale
Description	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.
Time Frame	Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Buspirone
Arm/Group Description	Subjects were maintained on placebo for 7 days.	Subjects were maintained on 45 mg buspirone daily for 7 days.
Measure Participants	8	8
Placebo Methamphetamine	0 (0)	9.25 (8.69)
10 mg Methamphetamine	18.50 (10.10)	13.75 (9.76)
30 mg Methamphetamine	26.00 (10.48)	27.25 (10.24)

24. Secondary Outcome

Title	Peak Diastolic Blood Pressure
Description	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.
Time Frame	Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Buspirone
Arm/Group Description	Subjects were maintained on placebo for 7 days.	Subjects were maintained on 45 mg buspirone daily for 7 days.
Measure Participants	8	8
Placebo Methamphetamine	77.50 (2.27)	80.13 (3.93)
10 mg Methamphetamine	80.75 (2.52)	83.00 (3.94)
30 mg Methamphetamine	83.80 (2.25)	84.50 (2.95)

25. Secondary Outcome

Title	Peak Systolic Blood Pressure
Description	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.
Time Frame	Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Buspirone
Arm/Group Description	Subjects were maintained on placebo for 7 days.	Subjects were maintained on 45 mg buspirone daily for 7 days.
Measure Participants	8	8
Placebo Methamphetamine	125.38 (3.84)	125.00 (2.68)
10 mg Methamphetamine	131.25 (3.71)	131.63 (3.72)
30 mg Methamphetamine	139.63 (4.18)	137.13 (2.57)

26. Secondary Outcome

Title	Peak Heart Rate
Description	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.
Time Frame	Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Buspirone
Arm/Group Description	Subjects were maintained on placebo for 7 days.	Subjects were maintained on 45 mg buspirone daily for 7 days.
Measure Participants	8	8
Placebo Methamphetamine	82.75 (6.65)	81.25 (2.69)
10 mg Methamphetamine	86.13 (3.27)	85.13 (5.00)
30 mg Methamphetamine	85.38 (5.90)	90.63 (3.89)

27. Secondary Outcome

Title	Peak Temperature
Description	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.
Time Frame	Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Buspirone
Arm/Group Description	Subjects were maintained on placebo for 7 days.	Subjects were maintained on 45 mg buspirone daily for 7 days.
Measure Participants	8	8
Placebo Methamphetamine	98.48 (0.07)	98.41 (0.08)
10 mg Methamphetamine	98.44 (0.10)	98.46 (0.05)
30 mg Methamphetamine	98.33 (0.07)	98.43 (0.05)

Adverse Events

Time Frame	Approximately 25 days of inpatient admission
Arm/Group Title	Placebo		Buspirone
Arm/Group Description	All completing subjects who received placebo maintenance.		All completing subjects who received buspirone maintenance.
All Cause Mortality
	Placebo		Buspirone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/8 (0%)
Serious Adverse Events
	Placebo		Buspirone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/8 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Buspirone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/8 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.