Cocaine Use Reduction and Health

Cocaine Use Disorder Clinical Trial

— RCT (04)  

Official title:

Cardiovascular, Immune and Psychosocial Benefits of Reduced Cocaine Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03224546
• Other study ID #: Randomized Clinical Trial (04)
• Secondary ID: R01DA043938
• Status: Completed
• Phase: N/A
• Start date: September 15, 2017
• Est. completion date: January 15, 2024

Study information

• Verified date: January 2024
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: January 15, 2024
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cocaine Use Disorder

Intervention

Behavioral:
• Contingency Management
Subjects will receive payments for providing cocaine negative urine samples.

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
William Stoops	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelin-1 levels	Endothelin-1 levels will be measured throughout subject participation. They will be recorded in pg/ml.	At baseline
Primary	Systolic blood pressure	Systolic blood pressure will be recorded during subject visits. Systolic blood pressure will be recorded in mmHg	At baseline
Primary	Diastolic blood pressure	Diastolic blood pressure will be recorded during subject visits. Systolic blood pressure will be recorded in mmHg	At baseline
Primary	Heart rate	Heart rate will be recorded during subject visits. Systolic blood pressure will be recorded in beats per minute	At baseline
Primary	Cocaine use	Cocaine use will be assessed with qualitative urine screens during subject visits. Results will be coded as positive or negative.	At baseline
Primary	Peripheral arterial tonometry (PAT)	PAT will be asssessed using the Endo-PAT2000 system. The outcome will be recorded as the reactive hyperemia index.	At baseline
Primary	Electrocardiogram	Electrocardiograms will be completed throughout study participation.	At baseline, 12 weeks after study entry, 4, 12 and 24 weeks after study completion.
Primary	Endothelin-1 levels	Endothelin-1 levels will be measured. They will be recorded in pg/ml.	6 weeks after study entry.
Primary	Endothelin-1 levels	Endothelin-1 levels will be measured. They will be recorded in pg/ml.	12 weeks after study entry.
Primary	Endothelin-1 levels	Endothelin-1 levels will be measured. They will be recorded in pg/ml.	4 weeks after study completion
Primary	Endothelin-1 levels	Endothelin-1 levels will be measured. They will be recorded in pg/ml.	12 weeks after study completion
Primary	Endothelin-1 levels	Endothelin-1 levels will be measured. They will be recorded in pg/ml.	24 weeks after study completion
Primary	Systolic blood pressure	Systolic blood pressure will be recorded during subject visits. Systolic blood pressure will be recorded in mmHg	Change from baseline across the 12 week intervention
Primary	Systolic blood pressure	Systolic blood pressure will be recorded during subject visits. Systolic blood pressure will be recorded in mmHg	4 weeks after study completion
Primary	Systolic blood pressure	Systolic blood pressure will be recorded during subject visits. Systolic blood pressure will be recorded in mmHg	8 weeks after study completion
Primary	Systolic blood pressure	Systolic blood pressure will be recorded during subject visits. Systolic blood pressure will be recorded in mmHg	12 weeks after study completion
Primary	Systolic blood pressure	Systolic blood pressure will be recorded during subject visits. Systolic blood pressure will be recorded in mmHg	24 weeks after study completion
Primary	Diastolic blood pressure	Diastolic blood pressure will be recorded during subject visits. Diastolic blood pressure will be recorded in mmHg	Change from baseline across the 12 week intervention
Primary	Diastolic blood pressure	Diastolic blood pressure will be recorded during subject visits. Diastolic blood pressure will be recorded in mmHg	4 weeks after study completion
Primary	Diastolic blood pressure	Diastolic blood pressure will be recorded during subject visits. Diastolic blood pressure will be recorded in mmHg	8 weeks after study completion
Primary	Diastolic blood pressure	Diastolic blood pressure will be recorded during subject visits. Diastolic blood pressure will be recorded in mmHg	12 weeks after study completion
Primary	Diastolic blood pressure	Diastolic blood pressure will be recorded during subject visits. Diastolic blood pressure will be recorded in mmHg	24 weeks after study completion
Primary	Heart rate	Heart rate will be recorded during subject visits. Heart rate will be recorded in beats per minute	Change from baseline across the 12 week intervention
Primary	Heart rate	Heart rate will be recorded during subject visits. Heart rate will be recorded in beats per minute	4 weeks after study completion
Primary	Heart rate	Heart rate will be recorded during subject visits. Heart rate will be recorded in beats per minute	8 weeks after study completion
Primary	Heart rate	Heart rate will be recorded during subject visits. Heart rate will be recorded in beats per minute	12 weeks after study completion
Primary	Heart rate	Heart rate will be recorded during subject visits. Heart rate will be recorded in beats per minute	24 weeks after study completion
Primary	Cocaine use	Cocaine use will be assessed with qualitative urine screens during subject visits. Results will be coded as positive or negative.	Change from baseline across the 12 week intervention
Primary	Cocaine use	Cocaine use will be assessed with qualitative urine screens during subject visits. Results will be coded as positive or negative.	4 weeks after study completion
Primary	Cocaine use	Cocaine use will be assessed with qualitative urine screens during subject visits. Results will be coded as positive or negative.	8 weeks after study completion
Primary	Cocaine use	Cocaine use will be assessed with qualitative urine screens during subject visits. Results will be coded as positive or negative.	12 weeks after study completion
Primary	Cocaine use	Cocaine use will be assessed with qualitative urine screens during subject visits. Results will be coded as positive or negative.	24 weeks after study completion
Primary	Peripheral arterial tonometry (PAT)	PAT will be asssessed using the Endo-PAT2000 system. The outcome will be recorded as the reactive hyperemia index.	12 weeks after study entry
Primary	Peripheral arterial tonometry (PAT)	PAT will be asssessed using the Endo-PAT2000 system. The outcome will be recorded as the reactive hyperemia index.	4 weeks after study completion
Primary	Peripheral arterial tonometry (PAT)	PAT will be asssessed using the Endo-PAT2000 system. The outcome will be recorded as the reactive hyperemia index.	8 weeks after study completion
Primary	Peripheral arterial tonometry (PAT)	PAT will be asssessed using the Endo-PAT2000 system. The outcome will be recorded as the reactive hyperemia index.	12 weeks after study completion
Primary	Peripheral arterial tonometry (PAT)	PAT will be asssessed using the Endo-PAT2000 system. The outcome will be recorded as the reactive hyperemia index.	24 weeks after study completion
Primary	Electrocardiogram	Electrocardiograms will be completed.	12 weeks after study entry
Primary	Electrocardiogram	Electrocardiograms will be completed.	4 weeks after study completion
Primary	Electrocardiogram	Electrocardiograms will be completed.	12 weeks after study completion
Primary	Electrocardiogram	Electrocardiograms will be completed.	24 weeks after study completion
Secondary	Delayed type hypersensitivity to candida yeast	Delayed type hypersensitivity to candida yeast will be determined throughout the trial. The outcome will be measured as the mean of the longest and orthogonal diameters of each induration using the ballpoint pen method, in which a line is drawn with a ballpoint pen toward the margin of the reaction. When resistance due to induration is encountered, the pen is lifted. This method defines the margins of the induration	At baseline, 6 and 12 weeks after study entry, 4, 12 and 24 weeks after study completion.
Secondary	Interleukin-10	Interleukin-10 levels will be measured throughout subject participation. They will be recorded in pg/ml.	At baseline, 6 and 12 weeks after study entry, 4, 12 and 24 weeks after study completion.
Secondary	Weight	Weight will be recorded in kilograms throughout subject participation.	At baseline, 3 days/week during the 12 week intervention, 4, 8, 12 and 24 weeks after study completion
Secondary	Sleep	Sleep will be assessed with the Saint Mary's Hospital Sleep questionnaire throughout subject participation.	At baseline, 1 time weekly during the 12 week intervention, 4, 8, 12 and 24 weeks after study completion
Secondary	Depression	Depressive symptoms will be assessed with the Hamilton Depression Scale throughout subject participation.	At baseline, 1 time weekly during the 12 week intervention, 4, 8, 12 and 24 weeks after study completion
Secondary	HIV Risk Behavior	HIV Risk Behavior will be assessed with the HIV Risk Behavior Scale throughout subject participation.	At baseline, 1 time weekly during the 12 week intervention, 4, 8, 12 and 24 weeks after study completion
Secondary	Addiction Severity	Addiction severity will be assessed with the Addiction Severity Index-lite throughout subject participation.	At baseline, weeks 4, 8 and 12 during the 12 week intervention, 4, 8, 12 and 24 weeks after study completion
Secondary	Drug use	Drug use will be assessed with the Timeline Followback Scale throughout subject participation.	At baseline, weeks 4, 8 and 12 during the 12 week intervention, 4, 8, 12 and 24 weeks after study completion
Secondary	Drug use	Drug use will be assessed with qualitative urine screens throughout subject participation. Results will be coded as positive or negative.	At baseline, 3 times weekly during the 12 week intervention, 4, 8, 12 and 24 weeks after study completion
Secondary	Cocaine use disorder	Cocaine use disorder severity will be assessed with the structured clinical interview for DSM-5 throughout study participation. Results will be coded as none, mild, moderate or sever.	At baseline, week 12 of study participation, 4, 12 and 24 weeks after study completion
Secondary	Adverse events	Adverse events will be queried throughout study participation.	At baseline, 1 time weekly during the 12 week intervention, 4, 8, 12 and 24 weeks after study completion