SXC-2023 Cocaine Interaction Study (NCT06343532) | Clinical Trial Compass
CompletedPhase 1
SXC-2023 Cocaine Interaction Study
United States19 participantsStarted 2024-10-08
Plain-language summary
The goal of this clinical trial is to determine whether there are any interactions between the study drug and cocaine. Researchers will compare a treatment group and a placebo group to see if they experience any effects when administered cocaine after taking the treatment/placebo.
Who can participate
Age range
18 Years – 59 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Be participants who are cocaine-experienced and not seeking treatment for cocaine use disorder.
. Males and females between 18 and 59 years of age, inclusive.
. Have a body mass index (BMI) within a range of 17.0 to 36.0 kg/m2 and a minimum weight of at least 50.0 kg at screening.
. Have experience using cocaine by the smoked or i.v. route at least 6 times over the participant's lifetime prior to clinic intake (Day -3) and at least one use within the past 3 months.
. Provide a urine sample positive for cocaine at least once during screening (Days -28 to -4) and a urine test negative for cocaine at clinic intake.
. Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures.
. A female study participant must meet one of the following criteria:
. Be able to comply with protocol requirements, rules and regulations of the study site, and be likely to complete all the study treatments.
Exclusion criteria
. Have a current or past history of seizure disorder, including alcohol- or stimulant-related seizure, febrile seizure, or significant family history of idiopathic seizure disorder.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total Number of Treatment-Emergent Adverse Events (Safety and Tolerability) of Oral SXC-2023 Co-administered With Intravenous Cocaine
Timeframe: Study Days -2,1,2,8,9,11
2
Maximum Pulse (After 20 mg i.v. Cocaine)
Timeframe: Study Day 8, 30 min pre till 5 hours post cocaine infusion
3
Maximum Pulse (After 40 mg i.v. Cocaine)
Timeframe: Study Day 9, 30 min pre till 5 hours post cocaine infusion
4
Maximum Systolic Blood Pressure (After 20 mg i.v. Cocaine)
Timeframe: Study Day 8, 30 min pre till 5 hours post cocaine infusion
5
Maximum Systolic Blood Pressure (After 40 mg i.v. Cocaine)
Timeframe: Study Day 9, 30 min pre till 5 hours post cocaine infusion
6
Maximum Diastolic Blood Pressure (After 20 mg i.v. Cocaine)
Timeframe: Study Day 8, 30 min pre till 5 hours post cocaine infusion
7
Maximum Diastolic Blood Pressure (After 40 mg i.v. Cocaine)
. Have any previous medically adverse reaction to cocaine, including loss of consciousness, chest pain, paranoid reaction or seizure.
. Have clinically significant findings in the opinion of an investigator based on the MINI (version 7.0) neuropsychiatric interview.
. Be pregnant or lactating.
. Have a sitting systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg and heart rate \> 100 beats per minute at screening and clinic intake.
. Have a history of liver disease or current elevation of aspartate aminotransferase (AST), alanine aminotransferase (ALT), 2 × the upper limit of normal.
. Blood donation (excluding plasma donation) of approximately 500 mL within 56 days prior to screening.
. Plasma donation within 7 days prior to screening.
Timeframe: Study Day 9, 30 min pre till 5 hours post cocaine infusion