N/A
N=127
Cocaine Use Reduction and Health
Cocaine Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03224546 ↗Enrolled (actual)
127
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Endothelin-1 Levels — 2.15; 2.063; 1.956 pg/ml
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Contingency Management (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- William Stoops
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Endothelin-1 Levels |
2.093; 2.083; 2.086 | — |
| PRIMARY Endothelin-1 Levels |
2.093; 2.083; 2.086 | — |
| PRIMARY Endothelin-1 Levels |
2.093; 2.083; 2.086 | — |
| PRIMARY Mean Arterial Pressure |
97.98; 102.10; 93.05 | — |
| PRIMARY Mean Arterial Pressure |
97.98; 102.10; 93.05 | — |
| PRIMARY Mean Arterial Pressure |
97.98; 102.10; 93.05 | — |
| PRIMARY Mean Arterial Pressure |
97.98; 102.10; 93.05 | — |
| PRIMARY Mean Arterial Pressure |
97.98; 102.10; 93.05 | — |
| PRIMARY Mean Arterial Pressure |
97.98; 102.10; 93.05 | — |
| PRIMARY Mean Arterial Pressure |
97.98; 102.10; 93.05 | — |
| PRIMARY Mean Arterial Pressure |
97.98; 102.10; 93.05 | — |
| PRIMARY Mean Arterial Pressure |
97.98; 102.10; 93.05 | — |
| PRIMARY Mean Arterial Pressure |
97.98; 102.10; 93.05 | — |
| PRIMARY Mean Arterial Pressure |
97.98; 102.10; 93.05 | — |
| PRIMARY Mean Arterial Pressure |
97.98; 102.10; 93.05 | — |
| PRIMARY Mean Arterial Pressure |
97.98; 102.10; 93.05 | — |
| SECONDARY Interleukin-10 |
.384; .481; .230 | — |
| SECONDARY Interleukin-10 |
.384; .481; .230 | — |
| SECONDARY Interleukin-10 |
.384; .481; .230 | — |
| SECONDARY Total Sleep Time |
435; 378.23; 387.05 | — |
| SECONDARY Total Sleep Time |
435; 378.23; 387.05 | — |
| SECONDARY Total Sleep Time |
435; 378.23; 387.05 | — |
| SECONDARY Total Sleep Time |
435; 378.23; 387.05 | — |
| SECONDARY Total Sleep Time |
435; 378.23; 387.05 | — |
| SECONDARY Total Sleep Time |
435; 378.23; 387.05 | — |
| SECONDARY Total Sleep Time |
435; 378.23; 387.05 | — |
| SECONDARY Total Sleep Time |
435; 378.23; 387.05 | — |
| SECONDARY Total Sleep Time |
435; 378.23; 387.05 | — |
| SECONDARY Total Sleep Time |
435; 378.23; 387.05 | — |
| SECONDARY Total Sleep Time |
435; 378.23; 387.05 | — |
| SECONDARY Total Sleep Time |
435; 378.23; 387.05 | — |
| SECONDARY Total Sleep Time |
435; 378.23; 387.05 | — |
| SECONDARY Hamilton Depression Scale Score |
1; 0; 0 | — |
| SECONDARY Hamilton Depression Scale Score |
1; 0; 0 | — |
| SECONDARY Hamilton Depression Scale Score |
1; 0; 0 | — |
| SECONDARY Hamilton Depression Scale Score |
1; 0; 0 | — |
| SECONDARY Hamilton Depression Scale Score |
1; 0; 0 | — |
| SECONDARY Hamilton Depression Scale Score |
1; 0; 0 | — |
| SECONDARY Hamilton Depression Scale Score |
1; 0; 0 | — |
| SECONDARY Hamilton Depression Scale Score |
1; 0; 0 | — |
| SECONDARY Hamilton Depression Scale Score |
1; 0; 0 | — |
| SECONDARY Hamilton Depression Scale Score |
1; 0; 0 | — |
| SECONDARY Hamilton Depression Scale Score |
1; 0; 0 | — |
| SECONDARY Hamilton Depression Scale Score |
1; 0; 0 | — |
| SECONDARY Hamilton Depression Scale Score |
1; 0; 0 | — |
| SECONDARY Criteria for Cocaine Use Disorder Diagnosis |
6.2; 4.8; 6.5 | — |
| SECONDARY Criteria for Cocaine Use Disorder Diagnosis |
6.2; 4.8; 6.5 | — |
| SECONDARY Reactive Hyperemia Index |
.53; .81; .42 | — |
| SECONDARY Reactive Hyperemia Index |
.53; .81; .42 | — |
Summary
Reduced drug use is a clinically meaningful target for treatment development, but few studies have evaluated the positive impacts produced by this behavioral change, preventing adoption of this endpoint in clinical trials. The proposed research will fill that critical knowledge gap by demonstrating the biopsychosocial benefits of reduced cocaine use. These data will be used to change current accepted cocaine treatment endpoints and accelerate identification of therapies for cocaine use disorder.
Eligibility Criteria
Inclusion Criteria
- Age 18 or older
- Self-report of recent cocaine use verified by a cocaine-positive urine sample
- Meet moderate-severe Cocaine Use Disorder Criteria
- Seeking treatment for their cocaine use
- Able to commit to 12-week intervention, plus 24-week follow up
Exclusion Criteria
- History of serious physical or psychiatric disease (e.g., physical dependence on any drug requiring medically managed detoxification, unstable angina, uncontrolled cardiac arrhythmia, aortic stenosis, self-reported compromised immune function, extreme hypersensitivity/allergy to candida yeast or similar products, severe diagnosis for other substance use disorder) that would interfere with study participation
- Current physical or psychiatric disease that would interfere with study participation
- Poor veinous access, precluding blood draws
Data sourced from ClinicalTrials.gov (NCT03224546). 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.