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 range18 Years – 59 Years
SexALL
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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.
✕. Have any previous medically adverse reaction to cocaine, including loss of consciousness, chest pain, paranoid reaction or seizure.
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)
Timeframe: Study Day 9, 30 min pre till 5 hours post cocaine infusion
. 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.