Phase 1, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess Potential Interactions Between Intravenous Cocaine and Oral SXC-2023
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of Oral SXC-2023 Co-administered with Intravenous Cocaine
研究概览
简要总结
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.
详细描述
This is a double-blind, placebo-controlled, parallel group study to compare the effects of SXC-2023 versus placebo control on intravenous cocaine's physiological and subjective effects in non-treatment seeking cocaine-experienced volunteers. Participants will be 18 to 59 years of age who have used cocaine by the smoked or intravenous route at least 6 times in the past 12 months prior to clinic intake, with at least one use within the past 3 months. Approximately twenty participants will be randomized to 2 groups, receiving either SXC-2023 or placebo treatment for 7 days. Adverse events and cardiovascular responses will be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In order to participate in the study, participants must:
- •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.
- •The masculine / feminine gender is used without any discrimination and with the aim to lighten the text.
- •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:
- •If of childbearing potential - agrees to use one of the accepted contraceptive regimens from at least 30 days prior to the first administration of the study medication, during the study, and for at least 30 days after the last dose of the study medication. An acceptable method of contraception includes one of the following:
- •i. Abstinence from heterosexual intercourse ii. Hormonal contraceptives (oral/injectable/implant/insertable hormonal birth control products, transdermal patch) iii. Intrauterine device (with or without hormones) OR agrees to use a double barrier method (e.g., condom and spermicide) during the study and for at least 30 days after the last dose of the study medication.
- •If a female of non-childbearing potential - should be surgically sterile (i.e., has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation/occlusion) or in a menopausal state (at least 1 year without menses), as confirmed by FSH levels (≥ 40 mIU/mL).
- •A male study participant that engages in sexual activity that has the risk of pregnancy must agree to use a double barrier method (e.g., condom and spermicide) and agree to not donate sperm during the study and for at least 90 days after the last dose of the study medication.
- •Be able to comply with protocol requirements, rules and regulations of the study site, and be likely to complete all the study treatments.
排除标准
- •In order to participate in the study, participants must not:
- •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.
- •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.
- •Treatment with an investigational drug within 30 days or 5 times the half-life (whichever is longer) prior to screening.
- •Have any clinically significant finding on medical history, physical examination, clinical laboratory test, vital signs or ECGs that contraindicate participation in the study.
- •Have a history of suicide attempts or current or recent evidence of suicidal ideation in the past 12 months based on the Columbia-Suicide Severity Rating Scale (C-SSRS).
- •Have a positive urine drug screen upon clinic intake (Day -3) for any of the following drugs: alcohol, amphetamine/methamphetamine, barbiturates, benzodiazepines, buprenorphine, cocaine, fentanyl, 3,4-methylenedioxymethamphetamine (MDMA), methadone, phencyclidine/phenylcyclohexyl piperidine (PCP), propoxyphene, and opioids (e.g., codeine, heroin, morphine, oxycodone, etc.). If a participant presents with a positive urine drug screen for cocaine or alcohol at clinic intake (Day -3), the participant may be rescheduled one time at the discretion of an investigator or designee as long as clinic intake is within the total screening window.
- •Have used any prescription drugs within 14 days of clinic intake or non-prescription drugs or herbal remedies within 7 days of clinic intake.
- •Be unable to distinguish between a 20 mg and 40 mg dose of cocaine i.v. based on the high effects VAS at either the 5 or 10 minute time point during the screening infusion.
- •Have a positive serology for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCVab), or human immunodeficiency virus (HIV).
- •Have positive results for a coronavirus disease 2019 (COVID-19) test performed after screening is complete and participant is confirmed, but prior to admission.
研究组 & 干预措施
SXC-2023 Placebo
Placebo: 800mg once a day for 7 days
干预措施: SXC-2023 Placebo (Drug)
SXC-2023
SXC-2023: 800mg once a day for 7 days
干预措施: SXC-2023 (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of Oral SXC-2023 Co-administered with Intravenous Cocaine
时间窗: Study Days -2,1,2,8,9,11
Determine if there are significant interactions between oral SXC-2023 treatment concurrent with 20 and 40 mg intravenous cocaine infusions by measuring incidence of treatment emergent adverse events using the most recent version of the Medical Dictionary of Regulatory Activities (MedDRA) preferred terms, relationship to the treatment, and maximum severity, either reported by the subject or by clinically significant abnormal findings on: i. Physical examination ii. Rate of change in vital signs assessments of heart rate, blood pressure, respiration rate, and temperature iii. Rate of change in ECG assessment iv. Rate of clinical laboratory changes
Total Number of Treatment-Emergent Adverse Events (Safety and Tolerability) of Oral SXC-2023 Co-administered With Intravenous Cocaine
时间窗: Study Days -2,1,2,8,9,11
Assessing the number of treatment emergent adverse events using the most recent version of the Medical Dictionary of Regulatory Activities (MedDRA) preferred terms. Adverse events were either reported by the participants or determined by clinically significant abnormal findings on: i. Physical examination ii. Measurement of vital signs (heart rate, blood pressure) iii. Clinical laboratory findings
Maximum Pulse (After 20 mg i.v. Cocaine)
时间窗: Study Day 8, 30 min pre till 5 hours post cocaine infusion
Maximum heart rate (bpm) after cocaine infusion 20 mg i.v.
Maximum Pulse (After 40 mg i.v. Cocaine)
时间窗: Study Day 9, 30 min pre till 5 hours post cocaine infusion
Maximum heart rate (bpm) after cocaine infusion 40 mg i.v.
Maximum Systolic Blood Pressure (After 20 mg i.v. Cocaine)
时间窗: Study Day 8, 30 min pre till 5 hours post cocaine infusion
Maximum Systolic Blood Pressure (mmHg) after cocaine infusion 20 mg i.v.
Maximum Systolic Blood Pressure (After 40 mg i.v. Cocaine)
时间窗: Study Day 9, 30 min pre till 5 hours post cocaine infusion
Maximum Systolic Blood Pressure (mmHg) after cocaine infusion 40 mg i.v.
Maximum Diastolic Blood Pressure (After 20 mg i.v. Cocaine)
时间窗: Study Day 8, 30 min pre till 5 hours post cocaine infusion
Maximum Diastolic Blood Pressure (mmHg) after cocaine infusion 20 mg i.v.
Maximum Diastolic Blood Pressure (After 40 mg i.v. Cocaine)
时间窗: Study Day 9, 30 min pre till 5 hours post cocaine infusion
Maximum Diastolic Blood Pressure (mmHg) after cocaine infusion 40 mg i.v.
次要结局
未报告次要终点