Trial Outcomes & Findings for Impact of Buspirone Maintenance on the Reinforcing Effects of Cocaine (NCT NCT01639157)
NCT ID: NCT01639157
Last Updated: 2016-02-19
Results Overview
The reinforcing effects of cocaine were determined using a modified progressive ratio procedure (Stoops et al., 2010) in which subjects made 6 choices between available each available cocaine dose and money (US$0.25). Reinforcing effects are measured for each cocaine dose during both buspirone and placebo maintenance.
COMPLETED
NA
9 participants
One test per cocaine dose level per intervention for each participant over his/her 2 week inpatient admission
2016-02-19
Participant Flow
Participant milestones
| Measure |
Buspirone Then Placebo
Subjects were maintained on 30 mg buspirone daily for 6 days, then they were crossed over to placebo daily for 6 days.
|
Placebo Then Buspirone
Subjects were maintained on placebo daily for 6 days, then they were crossed over to 30 mg buspirone daily for 6 days.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
5
|
|
Overall Study
COMPLETED
|
4
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Buspirone Maintenance on the Reinforcing Effects of Cocaine
Baseline characteristics by cohort
| Measure |
All Study Participants
n=9 Participants
Subjects were maintained on oral buspirone (10 mg administered 3 times daily) or placebo for 6 days each during the study in random order.
|
|---|---|
|
Age, Continuous
|
39.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One test per cocaine dose level per intervention for each participant over his/her 2 week inpatient admissionThe reinforcing effects of cocaine were determined using a modified progressive ratio procedure (Stoops et al., 2010) in which subjects made 6 choices between available each available cocaine dose and money (US$0.25). Reinforcing effects are measured for each cocaine dose during both buspirone and placebo maintenance.
Outcome measures
| Measure |
Buspirone
n=9 Participants
Subjects were maintained on 30 mg buspirone daily for 6 days.
|
Placebo
n=9 Participants
Subjects were maintained on placebo daily for 6 days.
|
|---|---|---|
|
Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative
0 mg Cocaine
|
1.00 Number of Cocaine Choices
Standard Error 0.707
|
1.22 Number of Cocaine Choices
Standard Error 0.813
|
|
Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative
15 mg Cocaine
|
5.56 Number of Cocaine Choices
Standard Error 0.338
|
5.33 Number of Cocaine Choices
Standard Error 0.441
|
|
Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative
45 mg Cocaine
|
5 Number of Cocaine Choices
Standard Error .289
|
4.89 Number of Cocaine Choices
Standard Error .455
|
SECONDARY outcome
Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine 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 cocaine dose under both buspirone and placebo conditions.
Outcome measures
| Measure |
Buspirone
n=9 Participants
Subjects were maintained on 30 mg buspirone daily for 6 days.
|
Placebo
n=9 Participants
Subjects were maintained on placebo daily for 6 days.
|
|---|---|---|
|
Peak Score on Sedative Subscale of the Adjective Rating Scale
0 mg Cocaine
|
2.9 arbitrary units on a Likert-type scale
Standard Error 1.3
|
3.6 arbitrary units on a Likert-type scale
Standard Error 1.6
|
|
Peak Score on Sedative Subscale of the Adjective Rating Scale
15 mg Cocaine
|
4.4 arbitrary units on a Likert-type scale
Standard Error 1.7
|
4.8 arbitrary units on a Likert-type scale
Standard Error 1.8
|
|
Peak Score on Sedative Subscale of the Adjective Rating Scale
45 mg Cocaine
|
5.6 arbitrary units on a Likert-type scale
Standard Error 1.8
|
3.1 arbitrary units on a Likert-type scale
Standard Error 1.1
|
SECONDARY outcome
Timeframe: This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine 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 cocaine dose under both buspirone and placebo conditions.
Outcome measures
| Measure |
Buspirone
n=9 Participants
Subjects were maintained on 30 mg buspirone daily for 6 days.
|
Placebo
n=9 Participants
Subjects were maintained on placebo daily for 6 days.
|
|---|---|---|
|
Peak Systolic Blood Pressure
0 mg Cocaine
|
120.8 mmHg
Standard Error 3.3
|
120.6 mmHg
Standard Error 3.2
|
|
Peak Systolic Blood Pressure
15 mg Cocaine
|
128.7 mmHg
Standard Error 1.3
|
127.0 mmHg
Standard Error 3.4
|
|
Peak Systolic Blood Pressure
45 mg Cocaine
|
127.1 mmHg
Standard Error 2.9
|
131.8 mmHg
Standard Error 3.0
|
SECONDARY outcome
Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine 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 "sedative" 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 cocaine dose under both buspirone and placebo conditions.
Outcome measures
| Measure |
Buspirone
n=9 Participants
Subjects were maintained on 30 mg buspirone daily for 6 days.
|
Placebo
n=9 Participants
Subjects were maintained on placebo daily for 6 days.
|
|---|---|---|
|
Peak Score on Stimulant Subscale of the Adjective Rating Scale
0 mg Cocaine
|
5 arbitrary units on a Likert-type scale
Standard Error 1.7
|
4.4 arbitrary units on a Likert-type scale
Standard Error 1.1
|
|
Peak Score on Stimulant Subscale of the Adjective Rating Scale
15 mg Cocaine
|
9.8 arbitrary units on a Likert-type scale
Standard Error 1.7
|
9 arbitrary units on a Likert-type scale
Standard Error 1.5
|
|
Peak Score on Stimulant Subscale of the Adjective Rating Scale
45 mg Cocaine
|
11.4 arbitrary units on a Likert-type scale
Standard Error 2.1
|
11.3 arbitrary units on a Likert-type scale
Standard Error 2.0
|
SECONDARY outcome
Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine 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 cocaine dose under both buspirone and placebo conditions.
Outcome measures
| Measure |
Buspirone
n=9 Participants
Subjects were maintained on 30 mg buspirone daily for 6 days.
|
Placebo
n=9 Participants
Subjects were maintained on placebo daily for 6 days.
|
|---|---|---|
|
Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale
0 mg Cocaine
|
3.8 arbitary units on a Visual Analog Scale
Standard Error 3.0
|
3.7 arbitary units on a Visual Analog Scale
Standard Error 2.9
|
|
Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale
15 mg Cocaine
|
20.1 arbitary units on a Visual Analog Scale
Standard Error 6.0
|
17.4 arbitary units on a Visual Analog Scale
Standard Error 5.4
|
|
Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale
45 mg Cocaine
|
24.7 arbitary units on a Visual Analog Scale
Standard Error 7.7
|
33.3 arbitary units on a Visual Analog Scale
Standard Error 8.3
|
SECONDARY outcome
Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine 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 cocaine dose under both buspirone and placebo conditions.
Outcome measures
| Measure |
Buspirone
n=9 Participants
Subjects were maintained on 30 mg buspirone daily for 6 days.
|
Placebo
n=9 Participants
Subjects were maintained on placebo daily for 6 days.
|
|---|---|---|
|
Peak Ratings of "Any Effect" on the Visual Analog Scale
0 mg Cocaine
|
6.2 arbitary units on a Visual Analog Scale
Standard Error 4.8
|
6.1 arbitary units on a Visual Analog Scale
Standard Error 3.7
|
|
Peak Ratings of "Any Effect" on the Visual Analog Scale
15 mg Cocaine
|
23.0 arbitary units on a Visual Analog Scale
Standard Error 4.7
|
17.3 arbitary units on a Visual Analog Scale
Standard Error 5.2
|
|
Peak Ratings of "Any Effect" on the Visual Analog Scale
45 mg Cocaine
|
26 arbitary units on a Visual Analog Scale
Standard Error 6.5
|
33.4 arbitary units on a Visual Analog Scale
Standard Error 8.0
|
SECONDARY outcome
Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine 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 cocaine dose under both buspirone and placebo conditions.
Outcome measures
| Measure |
Buspirone
n=9 Participants
Subjects were maintained on 30 mg buspirone daily for 6 days.
|
Placebo
n=9 Participants
Subjects were maintained on placebo daily for 6 days.
|
|---|---|---|
|
Peak Ratings of "Bad Effects" on the Visual Analog Scale
0 mg Cocaine
|
4.3 arbitary units on a Visual Analog Scale
Standard Error 3.5
|
5.9 arbitary units on a Visual Analog Scale
Standard Error 3.8
|
|
Peak Ratings of "Bad Effects" on the Visual Analog Scale
15 mg Cocaine
|
6.7 arbitary units on a Visual Analog Scale
Standard Error 3.0
|
7.7 arbitary units on a Visual Analog Scale
Standard Error 2.9
|
|
Peak Ratings of "Bad Effects" on the Visual Analog Scale
45 mg Cocaine
|
12.2 arbitary units on a Visual Analog Scale
Standard Error 4.8
|
9.1 arbitary units on a Visual Analog Scale
Standard Error 4.4
|
SECONDARY outcome
Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine 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 cocaine dose under both buspirone and placebo conditions.
Outcome measures
| Measure |
Buspirone
n=9 Participants
Subjects were maintained on 30 mg buspirone daily for 6 days.
|
Placebo
n=9 Participants
Subjects were maintained on placebo daily for 6 days.
|
|---|---|---|
|
Peak Ratings of "Euphoric" on the Visual Analog Scale
0 mg Cocaine
|
5.6 arbitary units on a Visual Analog Scale
Standard Error 4.7
|
5.9 arbitary units on a Visual Analog Scale
Standard Error 4.9
|
|
Peak Ratings of "Euphoric" on the Visual Analog Scale
15 mg Cocaine
|
15.8 arbitary units on a Visual Analog Scale
Standard Error 8.2
|
13.1 arbitary units on a Visual Analog Scale
Standard Error 7.4
|
|
Peak Ratings of "Euphoric" on the Visual Analog Scale
45 mg Cocaine
|
16.4 arbitary units on a Visual Analog Scale
Standard Error 9.3
|
14.1 arbitary units on a Visual Analog Scale
Standard Error 6.9
|
SECONDARY outcome
Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine 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 cocaine dose under both buspirone and placebo conditions.
Outcome measures
| Measure |
Buspirone
n=9 Participants
Subjects were maintained on 30 mg buspirone daily for 6 days.
|
Placebo
n=9 Participants
Subjects were maintained on placebo daily for 6 days.
|
|---|---|---|
|
Peak Ratings of "Good Effects" on the Visual Analog Scale
0 mg Cocaine
|
4.8 arbitary units on a Visual Analog Scale
Standard Error 3.9
|
3.3 arbitary units on a Visual Analog Scale
Standard Error 2.6
|
|
Peak Ratings of "Good Effects" on the Visual Analog Scale
15 mg Cocaine
|
21.3 arbitary units on a Visual Analog Scale
Standard Error 4.9
|
15.7 arbitary units on a Visual Analog Scale
Standard Error 5.0
|
|
Peak Ratings of "Good Effects" on the Visual Analog Scale
45 mg Cocaine
|
21.2 arbitary units on a Visual Analog Scale
Standard Error 6.1
|
32.3 arbitary units on a Visual Analog Scale
Standard Error 6.8
|
SECONDARY outcome
Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine 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 cocaine dose under both buspirone and placebo conditions.
Outcome measures
| Measure |
Buspirone
n=9 Participants
Subjects were maintained on 30 mg buspirone daily for 6 days.
|
Placebo
n=9 Participants
Subjects were maintained on placebo daily for 6 days.
|
|---|---|---|
|
Peak Ratings of "High" on the Visual Analog Scale
0 mg Cocaine
|
5.1 arbitary units on a Visual Analog Scale
Standard Error 4.4
|
3.9 arbitary units on a Visual Analog Scale
Standard Error 3.4
|
|
Peak Ratings of "High" on the Visual Analog Scale
15 mg Cocaine
|
17.9 arbitary units on a Visual Analog Scale
Standard Error 5.2
|
12.7 arbitary units on a Visual Analog Scale
Standard Error 5.0
|
|
Peak Ratings of "High" on the Visual Analog Scale
45 mg Cocaine
|
21.4 arbitary units on a Visual Analog Scale
Standard Error 7.0
|
27.2 arbitary units on a Visual Analog Scale
Standard Error 6.0
|
SECONDARY outcome
Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine 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 cocaine dose under both buspirone and placebo conditions.
Outcome measures
| Measure |
Buspirone
n=9 Participants
Subjects were maintained on 30 mg buspirone daily for 6 days.
|
Placebo
n=9 Participants
Subjects were maintained on placebo daily for 6 days.
|
|---|---|---|
|
Peak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog Scale
0 mg Cocaine
|
3.9 arbitary units on a Visual Analog Scale
Standard Error 3.3
|
2.3 arbitary units on a Visual Analog Scale
Standard Error 1.3
|
|
Peak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog Scale
15 mg Cocaine
|
11.1 arbitary units on a Visual Analog Scale
Standard Error 6.3
|
9.1 arbitary units on a Visual Analog Scale
Standard Error 6.0
|
|
Peak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog Scale
45 mg Cocaine
|
20.1 arbitary units on a Visual Analog Scale
Standard Error 8.4
|
14.3 arbitary units on a Visual Analog Scale
Standard Error 4.8
|
SECONDARY outcome
Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine 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 cocaine dose under both buspirone and placebo conditions.
Outcome measures
| Measure |
Buspirone
n=9 Participants
Subjects were maintained on 30 mg buspirone daily for 6 days.
|
Placebo
n=9 Participants
Subjects were maintained on placebo daily for 6 days.
|
|---|---|---|
|
Peak Ratings of "Like Drug" on the Visual Analog Scale
0 mg Cocaine
|
3.6 arbitary units on a Visual Analog Scale
Standard Error 2.5
|
2.1 arbitary units on a Visual Analog Scale
Standard Error 1.5
|
|
Peak Ratings of "Like Drug" on the Visual Analog Scale
15 mg Cocaine
|
23.9 arbitary units on a Visual Analog Scale
Standard Error 6.0
|
18.3 arbitary units on a Visual Analog Scale
Standard Error 6.4
|
|
Peak Ratings of "Like Drug" on the Visual Analog Scale
45 mg Cocaine
|
30.3 arbitary units on a Visual Analog Scale
Standard Error 8.4
|
36.1 arbitary units on a Visual Analog Scale
Standard Error 7.8
|
SECONDARY outcome
Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.Subjects rated their feelings of "Nauseated, Queasy, Sick to Stomach" 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 cocaine dose under both buspirone and placebo conditions.
Outcome measures
| Measure |
Buspirone
n=9 Participants
Subjects were maintained on 30 mg buspirone daily for 6 days.
|
Placebo
n=9 Participants
Subjects were maintained on placebo daily for 6 days.
|
|---|---|---|
|
Peak Ratings of "Nauseated, Queasy, Sick to Stomach" on the Visual Analog Scale
0 mg Cocaine
|
3.8 arbitary units on a Visual Analog Scale
Standard Error 3.1
|
1.6 arbitary units on a Visual Analog Scale
Standard Error 1.1
|
|
Peak Ratings of "Nauseated, Queasy, Sick to Stomach" on the Visual Analog Scale
15 mg Cocaine
|
8.8 arbitary units on a Visual Analog Scale
Standard Error 5.7
|
10.6 arbitary units on a Visual Analog Scale
Standard Error 5.7
|
|
Peak Ratings of "Nauseated, Queasy, Sick to Stomach" on the Visual Analog Scale
45 mg Cocaine
|
13.4 arbitary units on a Visual Analog Scale
Standard Error 6.3
|
11.1 arbitary units on a Visual Analog Scale
Standard Error 5.4
|
SECONDARY outcome
Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine 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 cocaine dose under both buspirone and placebo conditions.
Outcome measures
| Measure |
Buspirone
n=9 Participants
Subjects were maintained on 30 mg buspirone daily for 6 days.
|
Placebo
n=9 Participants
Subjects were maintained on placebo daily for 6 days.
|
|---|---|---|
|
Peak Ratings of "Nervous, Anxious" on the Visual Analog Scale
0 mg Cocaine
|
3.6 arbitary units on a Visual Analog Scale
Standard Error 3.0
|
2 arbitary units on a Visual Analog Scale
Standard Error 1.4
|
|
Peak Ratings of "Nervous, Anxious" on the Visual Analog Scale
15 mg Cocaine
|
13.1 arbitary units on a Visual Analog Scale
Standard Error 5.8
|
10.2 arbitary units on a Visual Analog Scale
Standard Error 4.6
|
|
Peak Ratings of "Nervous, Anxious" on the Visual Analog Scale
45 mg Cocaine
|
17.2 arbitary units on a Visual Analog Scale
Standard Error 7.4
|
12.6 arbitary units on a Visual Analog Scale
Standard Error 5.2
|
SECONDARY outcome
Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine 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 cocaine dose under both buspirone and placebo conditions.
Outcome measures
| Measure |
Buspirone
n=9 Participants
Subjects were maintained on 30 mg buspirone daily for 6 days.
|
Placebo
n=9 Participants
Subjects were maintained on placebo daily for 6 days.
|
|---|---|---|
|
Peak Ratings of "Willing to Pay For" on the Visual Analog Scale
0 mg Cocaine
|
3.6 arbitary units on a Visual Analog Scale
Standard Error 2.7
|
3.1 arbitary units on a Visual Analog Scale
Standard Error 2.4
|
|
Peak Ratings of "Willing to Pay For" on the Visual Analog Scale
15 mg Cocaine
|
18.6 arbitary units on a Visual Analog Scale
Standard Error 5.4
|
13.9 arbitary units on a Visual Analog Scale
Standard Error 4.5
|
|
Peak Ratings of "Willing to Pay For" on the Visual Analog Scale
45 mg Cocaine
|
31.9 arbitary units on a Visual Analog Scale
Standard Error 10.9
|
31.3 arbitary units on a Visual Analog Scale
Standard Error 8.8
|
SECONDARY outcome
Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine 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 cocaine dose under both buspirone and placebo conditions.
Outcome measures
| Measure |
Buspirone
n=9 Participants
Subjects were maintained on 30 mg buspirone daily for 6 days.
|
Placebo
n=9 Participants
Subjects were maintained on placebo daily for 6 days.
|
|---|---|---|
|
Peak Ratings of "Performance Impaired" on the Visual Analog Scale
0 mg Cocaine
|
2.6 arbitary units on a Visual Analog Scale
Standard Error 2.1
|
4.3 arbitary units on a Visual Analog Scale
Standard Error 2.5
|
|
Peak Ratings of "Performance Impaired" on the Visual Analog Scale
15 mg Cocaine
|
8.8 arbitary units on a Visual Analog Scale
Standard Error 5.2
|
6.3 arbitary units on a Visual Analog Scale
Standard Error 3.3
|
|
Peak Ratings of "Performance Impaired" on the Visual Analog Scale
45 mg Cocaine
|
12.6 arbitary units on a Visual Analog Scale
Standard Error 6.8
|
18.2 arbitary units on a Visual Analog Scale
Standard Error 8.4
|
SECONDARY outcome
Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine 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 cocaine dose under both buspirone and placebo conditions.
Outcome measures
| Measure |
Buspirone
n=9 Participants
Subjects were maintained on 30 mg buspirone daily for 6 days.
|
Placebo
n=9 Participants
Subjects were maintained on placebo daily for 6 days.
|
|---|---|---|
|
Peak Ratings of "Performance Improved" on the Visual Analog Scale
0 mg Cocaine
|
2.7 arbitary units on a Visual Analog Scale
Standard Error 1.9
|
1.9 arbitary units on a Visual Analog Scale
Standard Error 1.3
|
|
Peak Ratings of "Performance Improved" on the Visual Analog Scale
15 mg Cocaine
|
8.9 arbitary units on a Visual Analog Scale
Standard Error 5.6
|
5.2 arbitary units on a Visual Analog Scale
Standard Error 2.8
|
|
Peak Ratings of "Performance Improved" on the Visual Analog Scale
45 mg Cocaine
|
4.7 arbitary units on a Visual Analog Scale
Standard Error 3.1
|
4.8 arbitary units on a Visual Analog Scale
Standard Error 2.7
|
SECONDARY outcome
Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine 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 cocaine dose under both buspirone and placebo conditions.
Outcome measures
| Measure |
Buspirone
n=9 Participants
Subjects were maintained on 30 mg buspirone daily for 6 days.
|
Placebo
n=9 Participants
Subjects were maintained on placebo daily for 6 days.
|
|---|---|---|
|
Peak Ratings of "Restless" on the Visual Analog Scale
0 mg Cocaine
|
4.1 arbitary units on a Visual Analog Scale
Standard Error 3.6
|
1.9 arbitary units on a Visual Analog Scale
Standard Error 1.2
|
|
Peak Ratings of "Restless" on the Visual Analog Scale
15 mg Cocaine
|
10.0 arbitary units on a Visual Analog Scale
Standard Error 6.3
|
10.2 arbitary units on a Visual Analog Scale
Standard Error 5.0
|
|
Peak Ratings of "Restless" on the Visual Analog Scale
45 mg Cocaine
|
13.0 arbitary units on a Visual Analog Scale
Standard Error 6.4
|
9.4 arbitary units on a Visual Analog Scale
Standard Error 4.4
|
SECONDARY outcome
Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine 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 cocaine dose under both buspirone and placebo conditions.
Outcome measures
| Measure |
Buspirone
n=9 Participants
Subjects were maintained on 30 mg buspirone daily for 6 days.
|
Placebo
n=9 Participants
Subjects were maintained on placebo daily for 6 days.
|
|---|---|---|
|
Peak Ratings of "Rush" on the Visual Analog Scale
0 mg Cocaine
|
3.6 arbitary units on a Visual Analog Scale
Standard Error 2.8
|
1.9 arbitary units on a Visual Analog Scale
Standard Error 1.3
|
|
Peak Ratings of "Rush" on the Visual Analog Scale
15 mg Cocaine
|
18.4 arbitary units on a Visual Analog Scale
Standard Error 5.1
|
12.4 arbitary units on a Visual Analog Scale
Standard Error 4.1
|
|
Peak Ratings of "Rush" on the Visual Analog Scale
45 mg Cocaine
|
20.1 arbitary units on a Visual Analog Scale
Standard Error 5.8
|
23.3 arbitary units on a Visual Analog Scale
Standard Error 6.2
|
SECONDARY outcome
Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine 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 cocaine dose under both buspirone and placebo conditions.
Outcome measures
| Measure |
Buspirone
n=9 Participants
Subjects were maintained on 30 mg buspirone daily for 6 days.
|
Placebo
n=9 Participants
Subjects were maintained on placebo daily for 6 days.
|
|---|---|---|
|
Peak Ratings of "Shaky, Jittery" on the Visual Analog Scale
0 mg Cocaine
|
4.8 arbitary units on a Visual Analog Scale
Standard Error 4.1
|
2.1 arbitary units on a Visual Analog Scale
Standard Error 1.5
|
|
Peak Ratings of "Shaky, Jittery" on the Visual Analog Scale
15 mg Cocaine
|
15.1 arbitary units on a Visual Analog Scale
Standard Error 6.0
|
11.4 arbitary units on a Visual Analog Scale
Standard Error 5.2
|
|
Peak Ratings of "Shaky, Jittery" on the Visual Analog Scale
45 mg Cocaine
|
18.9 arbitary units on a Visual Analog Scale
Standard Error 8.2
|
17.7 arbitary units on a Visual Analog Scale
Standard Error 5.3
|
SECONDARY outcome
Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine 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 cocaine dose under both buspirone and placebo conditions.
Outcome measures
| Measure |
Buspirone
n=9 Participants
Subjects were maintained on 30 mg buspirone daily for 6 days.
|
Placebo
n=9 Participants
Subjects were maintained on placebo daily for 6 days.
|
|---|---|---|
|
Peak Ratings of "Sluggish, Fatigued, Lazy" on the Visual Analog Scale
0 mg Cocaine
|
5.3 arbitary units on a Visual Analog Scale
Standard Error 4.2
|
12.9 arbitary units on a Visual Analog Scale
Standard Error 8.3
|
|
Peak Ratings of "Sluggish, Fatigued, Lazy" on the Visual Analog Scale
15 mg Cocaine
|
13.4 arbitary units on a Visual Analog Scale
Standard Error 8.0
|
12.7 arbitary units on a Visual Analog Scale
Standard Error 6.7
|
|
Peak Ratings of "Sluggish, Fatigued, Lazy" on the Visual Analog Scale
45 mg Cocaine
|
12.9 arbitary units on a Visual Analog Scale
Standard Error 6.8
|
7.7 arbitary units on a Visual Analog Scale
Standard Error 5.1
|
SECONDARY outcome
Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine 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 cocaine dose under both buspirone and placebo conditions.
Outcome measures
| Measure |
Buspirone
n=9 Participants
Subjects were maintained on 30 mg buspirone daily for 6 days.
|
Placebo
n=9 Participants
Subjects were maintained on placebo daily for 6 days.
|
|---|---|---|
|
Peak Ratings of "Stimulated" on the Visual Analog Scale
0 mg Cocaine
|
4.0 arbitary units on a Visual Analog Scale
Standard Error 3.1
|
4.2 arbitary units on a Visual Analog Scale
Standard Error 3.3
|
|
Peak Ratings of "Stimulated" on the Visual Analog Scale
15 mg Cocaine
|
18.7 arbitary units on a Visual Analog Scale
Standard Error 5.6
|
17.9 arbitary units on a Visual Analog Scale
Standard Error 5.7
|
|
Peak Ratings of "Stimulated" on the Visual Analog Scale
45 mg Cocaine
|
25.3 arbitary units on a Visual Analog Scale
Standard Error 7.6
|
32.3 arbitary units on a Visual Analog Scale
Standard Error 8.5
|
SECONDARY outcome
Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine 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 cocaine dose under both buspirone and placebo conditions.
Outcome measures
| Measure |
Buspirone
n=9 Participants
Subjects were maintained on 30 mg buspirone daily for 6 days.
|
Placebo
n=9 Participants
Subjects were maintained on placebo daily for 6 days.
|
|---|---|---|
|
Peak Ratings of "Willing to Take Again" on the Visual Analog Scale
0 mg Cocaine
|
3.3 arbitary units on a Visual Analog Scale
Standard Error 2.4
|
3.2 arbitary units on a Visual Analog Scale
Standard Error 2.5
|
|
Peak Ratings of "Willing to Take Again" on the Visual Analog Scale
15 mg Cocaine
|
27.7 arbitary units on a Visual Analog Scale
Standard Error 8.4
|
22.1 arbitary units on a Visual Analog Scale
Standard Error 8.3
|
|
Peak Ratings of "Willing to Take Again" on the Visual Analog Scale
45 mg Cocaine
|
34.6 arbitary units on a Visual Analog Scale
Standard Error 11.0
|
43.4 arbitary units on a Visual Analog Scale
Standard Error 10.5
|
SECONDARY outcome
Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine 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 cocaine dose under both buspirone and placebo conditions.
Outcome measures
| Measure |
Buspirone
n=9 Participants
Subjects were maintained on 30 mg buspirone daily for 6 days.
|
Placebo
n=9 Participants
Subjects were maintained on placebo daily for 6 days.
|
|---|---|---|
|
Peak Ratings of "Talkative, Friendly" on the Visual Analog Scale
0 mg Cocaine
|
3.2 arbitary units on a Visual Analog Scale
Standard Error 2.6
|
2.0 arbitary units on a Visual Analog Scale
Standard Error 1.3
|
|
Peak Ratings of "Talkative, Friendly" on the Visual Analog Scale
15 mg Cocaine
|
11.7 arbitary units on a Visual Analog Scale
Standard Error 5.3
|
11.2 arbitary units on a Visual Analog Scale
Standard Error 4.8
|
|
Peak Ratings of "Talkative, Friendly" on the Visual Analog Scale
45 mg Cocaine
|
12.1 arbitary units on a Visual Analog Scale
Standard Error 4.6
|
21.8 arbitary units on a Visual Analog Scale
Standard Error 8.0
|
SECONDARY outcome
Timeframe: This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine 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 cocaine dose under both buspirone and placebo conditions.
Outcome measures
| Measure |
Buspirone
n=9 Participants
Subjects were maintained on 30 mg buspirone daily for 6 days.
|
Placebo
n=9 Participants
Subjects were maintained on placebo daily for 6 days.
|
|---|---|---|
|
Peak Oral Temperature
0 mg Cocaine
|
98.2 Degrees Fahrenheit
Standard Error 0.1
|
98.3 Degrees Fahrenheit
Standard Error 0.2
|
|
Peak Oral Temperature
15 mg Cocaine
|
98.3 Degrees Fahrenheit
Standard Error 0.1
|
98.4 Degrees Fahrenheit
Standard Error 0.2
|
|
Peak Oral Temperature
45 mg Cocaine
|
98.1 Degrees Fahrenheit
Standard Error 0.1
|
98.4 Degrees Fahrenheit
Standard Error 0.1
|
SECONDARY outcome
Timeframe: This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine 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 cocaine dose under both buspirone and placebo conditions.
Outcome measures
| Measure |
Buspirone
n=9 Participants
Subjects were maintained on 30 mg buspirone daily for 6 days.
|
Placebo
n=9 Participants
Subjects were maintained on placebo daily for 6 days.
|
|---|---|---|
|
Peak Diastolic Blood Pressure
45 mg Cocaine
|
77.6 mmHg
Standard Error 2.7
|
77.6 mmHg
Standard Error 2.4
|
|
Peak Diastolic Blood Pressure
0 mg Cocaine
|
74.3 mmHg
Standard Error 2.1
|
73.3 mmHg
Standard Error 3.1
|
|
Peak Diastolic Blood Pressure
15 mg Cocaine
|
75.1 mmHg
Standard Error 2.5
|
74.6 mmHg
Standard Error 2.8
|
SECONDARY outcome
Timeframe: This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine 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 cocaine dose under both buspirone and placebo conditions.
Outcome measures
| Measure |
Buspirone
n=9 Participants
Subjects were maintained on 30 mg buspirone daily for 6 days.
|
Placebo
n=9 Participants
Subjects were maintained on placebo daily for 6 days.
|
|---|---|---|
|
Peak Heart Rate
0 mg Cocaine
|
75.9 beats per minute
Standard Error 3.6
|
79.7 beats per minute
Standard Error 3.6
|
|
Peak Heart Rate
15 mg Cocaine
|
79.9 beats per minute
Standard Error 3.8
|
79.6 beats per minute
Standard Error 4.6
|
|
Peak Heart Rate
45 mg Cocaine
|
82.8 beats per minute
Standard Error 2.7
|
89.3 beats per minute
Standard Error 5.4
|
Adverse Events
Buspirone
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place