Early Phase 1
N=15
n-Acetylcysteine and Cocaine
Cocaine Abuse · Cocaine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT02141620 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcome: Primary: Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative — 1.0; 0.1; 3.4; 3.9 Number of Cocaine Choices
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Cocaine (Drug); n-Acetylcysteine (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Kentucky
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative |
1.0; 0.1; 3.4; 3.9; 3.5; 3.9 | — |
| SECONDARY Peak Score on Sedative Subscale of the Adjective Rating Scale |
3.8; 3.9; 2.5; 2.4; 2.6; 2.6 | — |
| SECONDARY Peak Score on Stimulant Subscale of the Adjective Rating Scale |
6.1; 5.7; 9.8; 9.1; 12.2; 11.6 | — |
| SECONDARY Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale |
2.4; .9; 14.7; 13.9; 27.1; 20.5 | — |
| SECONDARY Peak Ratings of "Any Effect" on the Visual Analog Scale |
1.1; 1.4; 19.6; 16.7; 25.7; 28.2 | — |
| SECONDARY Peak Ratings of "Bad Effects" on the Visual Analog Scale |
1.2; 1.1; 4.2; 3.9; 10.1; 7.2 | — |
| SECONDARY Peak Ratings of "Euphoric" on the Visual Analog Scale |
2.6; 1.1; 9.4; 3.1; 15.1; 7.9 | — |
| SECONDARY Peak Ratings of "Good Effects" on the Visual Analog Scale |
1.1; 1.3; 14.8; 16.7; 25.3; 22.1 | — |
| SECONDARY Peak Ratings of "High" on the Visual Analog Scale |
.9; 1.4; 18.2; 16.9; 29.3; 27.1 | — |
| SECONDARY Peak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog Scale |
1.9; 1.1; 8.4; 5; 13.6; 15.6 | — |
| SECONDARY Peak Ratings of "Like Drug" on the Visual Analog Scale |
2.4; 2.3; 20.8; 19.7; 31.7; 26.9 | — |
| SECONDARY Peak Ratings of "Nauseous" on the Visual Analog Scale |
.9; 3.9; 2.5; 1.3; 8.1; 7.4 | — |
| SECONDARY Peak Ratings of "Nervous/Anxious" on the Visual Analog Scale |
2.4; .9; 2.3; .9; 7.5; 9.1 | — |
| SECONDARY Peak Ratings of "Willing to Pay For" on the Visual Analog Scale |
2.4; 3.6; 21; 19.2; 33.9; 31.3 | — |
| SECONDARY Peak Ratings of "Performance Impaired" on the Visual Analog Scale |
1.3; 1.4; 3.1; 2.9; 3.8; 7 | — |
| SECONDARY Peak Ratings of "Performance Improved" on the Visual Analog Scale |
1.5; .9; 7.3; 6.1; 10.1; 3.5 | — |
| SECONDARY Peak Ratings of "Restless" on the Visual Analog Scale |
1.0; 1.0; 3; 1.1; 3.4; 3.2 | — |
| SECONDARY Peak Ratings of "Rush" on the Visual Analog Scale |
1.2; .9; 12.1; 10.8; 24.6; 24.8 | — |
| SECONDARY Peak Ratings of "Shaky/Jittery" on the Visual Analog Scale |
2.3; 1.3; 6.1; 8.1; 14.6; 14.7 | — |
| SECONDARY Peak Ratings of "Sluggish/Fatigued/Lazy" on the Visual Analog Scale |
1.1; 1; 1.3; 1.6; 4.9; 2.1 | — |
| SECONDARY Peak Ratings of "Stimulated" on the Visual Analog Scale |
1.1; 1.2; 13.7; 7.5; 22.1; 18.3 | — |
| SECONDARY Peak Ratings of "Willing to Take Again" on the Visual Analog Scale |
4.2; 4.1; 27.6; 24.9; 35.4; 32.2 | — |
| SECONDARY Peak Ratings of "Talkative/Friendly" on the Visual Analog Scale |
2.2; .9; 9.5; 11.4; 22.3; 14.5 | — |
| SECONDARY Peak Diastolic Blood Pressure |
75.9; 74.9; 81.1; 82.3; 82.4; 79.9 | — |
| SECONDARY Peak Systolic Blood Pressure |
117.9; 117.2; 128.5; 128.6; 131.1; 127.3 | — |
| SECONDARY Peak Heart Rate |
72.4; 73.6; 82.2; 74.9; 84.3; 85.4 | — |
| SECONDARY Peak Temperature |
98.3; 98.3; 98.4; 98.3; 98.3; 98.3 | — |
Summary
This study will determine the initial efficacy, safety and tolerability of n-acetylcysteine as a pharmacotherapy for cocaine dependence. A rigorous, inpatient human laboratory study will be conducted in which the subjective, physiological and reinforcing effects of cocaine are evaluated during maintenance on placebo and n-acetylcysteine.
Eligibility Criteria
Inclusion Criteria
- Current cocaine use
- Current cigarette smoker
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 n-acetylcysteine
- History of schizophrenia in first degree relative
Data sourced from ClinicalTrials.gov (NCT02141620). 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.