N/A
N=9
Impact of Buspirone Maintenance on the Reinforcing Effects of Cocaine
Cocaine Use Disorders
Bottom Line
View on ClinicalTrials.gov: NCT01639157 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative — 1.00; 1.22; 5.56; 5.33 Number of Cocaine Choices
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Buspirone (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- William Stoops
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative |
1.00; 1.22; 5.56; 5.33; 5; 4.89 | — |
| SECONDARY Peak Score on Sedative Subscale of the Adjective Rating Scale |
2.9; 3.6; 4.4; 4.8; 5.6; 3.1 | — |
| SECONDARY Peak Systolic Blood Pressure |
120.8; 120.6; 128.7; 127.0; 127.1; 131.8 | — |
| SECONDARY Peak Score on Stimulant Subscale of the Adjective Rating Scale |
5; 4.4; 9.8; 9; 11.4; 11.3 | — |
| SECONDARY Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale |
3.8; 3.7; 20.1; 17.4; 24.7; 33.3 | — |
| SECONDARY Peak Ratings of "Any Effect" on the Visual Analog Scale |
6.2; 6.1; 23.0; 17.3; 26; 33.4 | — |
| SECONDARY Peak Ratings of "Bad Effects" on the Visual Analog Scale |
4.3; 5.9; 6.7; 7.7; 12.2; 9.1 | — |
| SECONDARY Peak Ratings of "Euphoric" on the Visual Analog Scale |
5.6; 5.9; 15.8; 13.1; 16.4; 14.1 | — |
| SECONDARY Peak Ratings of "Good Effects" on the Visual Analog Scale |
4.8; 3.3; 21.3; 15.7; 21.2; 32.3 | — |
| SECONDARY Peak Ratings of "High" on the Visual Analog Scale |
5.1; 3.9; 17.9; 12.7; 21.4; 27.2 | — |
| SECONDARY Peak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog Scale |
3.9; 2.3; 11.1; 9.1; 20.1; 14.3 | — |
| SECONDARY Peak Ratings of "Like Drug" on the Visual Analog Scale |
3.6; 2.1; 23.9; 18.3; 30.3; 36.1 | — |
| SECONDARY Peak Ratings of "Nauseated, Queasy, Sick to Stomach" on the Visual Analog Scale |
3.8; 1.6; 8.8; 10.6; 13.4; 11.1 | — |
| SECONDARY Peak Ratings of "Nervous, Anxious" on the Visual Analog Scale |
3.6; 2; 13.1; 10.2; 17.2; 12.6 | — |
| SECONDARY Peak Ratings of "Willing to Pay For" on the Visual Analog Scale |
3.6; 3.1; 18.6; 13.9; 31.9; 31.3 | — |
| SECONDARY Peak Ratings of "Performance Impaired" on the Visual Analog Scale |
2.6; 4.3; 8.8; 6.3; 12.6; 18.2 | — |
| SECONDARY Peak Ratings of "Performance Improved" on the Visual Analog Scale |
2.7; 1.9; 8.9; 5.2; 4.7; 4.8 | — |
| SECONDARY Peak Ratings of "Restless" on the Visual Analog Scale |
4.1; 1.9; 10.0; 10.2; 13.0; 9.4 | — |
| SECONDARY Peak Ratings of "Rush" on the Visual Analog Scale |
3.6; 1.9; 18.4; 12.4; 20.1; 23.3 | — |
| SECONDARY Peak Ratings of "Shaky, Jittery" on the Visual Analog Scale |
4.8; 2.1; 15.1; 11.4; 18.9; 17.7 | — |
| SECONDARY Peak Ratings of "Sluggish, Fatigued, Lazy" on the Visual Analog Scale |
5.3; 12.9; 13.4; 12.7; 12.9; 7.7 | — |
| SECONDARY Peak Ratings of "Stimulated" on the Visual Analog Scale |
4.0; 4.2; 18.7; 17.9; 25.3; 32.3 | — |
| SECONDARY Peak Ratings of "Willing to Take Again" on the Visual Analog Scale |
3.3; 3.2; 27.7; 22.1; 34.6; 43.4 | — |
| SECONDARY Peak Ratings of "Talkative, Friendly" on the Visual Analog Scale |
3.2; 2.0; 11.7; 11.2; 12.1; 21.8 | — |
| SECONDARY Peak Oral Temperature |
98.2; 98.3; 98.3; 98.4; 98.1; 98.4 | — |
| SECONDARY Peak Diastolic Blood Pressure |
74.3; 73.3; 75.1; 74.6; 77.6; 77.6 | — |
| SECONDARY Peak Heart Rate |
75.9; 79.7; 79.9; 79.6; 82.8; 89.3 | — |
Summary
Cocaine use disorders are an unrelenting public health concern. Intensive research efforts have yielded behavioral interventions that reduce cocaine 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 cocaine and alternative reinforcers. These preliminary data will be used to support further research developing buspirone as a pharmacotherapy for cocaine use disorders. We hypothesize that buspirone will attenuate the reinforcing effects of cocaine and increase the reinforcing effects of alternative reinforcers.
Eligibility Criteria
Inclusion Criteria
- Recent cocaine 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 cocaine or buspirone
Data sourced from ClinicalTrials.gov (NCT01639157). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.