SXC-2023 Cocaine Interaction Study

NCT06343532 | Completed Phase 1 Results FDA Drug

• 1 other identifier: NIDA-SXC-Ph1b-001
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cocaine Use Disorder

Keywords

Cocaine; Benzoylecgonine; Glutamate; Cysteine

Outcome Measures

Primary Outcomes (7)

• Total Number of Treatment-Emergent Adverse Events (Safety and Tolerability) of Oral SXC-2023 Co-administered With Intravenous Cocaine

  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

  Study Days -2,1,2,8,9,11

• Maximum Pulse (After 20 mg i.v. Cocaine)

  Maximum heart rate (bpm) after cocaine infusion 20 mg i.v.

  Study Day 8, 30 min pre till 5 hours post cocaine infusion

• Maximum Pulse (After 40 mg i.v. Cocaine)

  Maximum heart rate (bpm) after cocaine infusion 40 mg i.v.

  Study Day 9, 30 min pre till 5 hours post cocaine infusion

• Maximum Systolic Blood Pressure (After 20 mg i.v. Cocaine)

  Maximum Systolic Blood Pressure (mmHg) after cocaine infusion 20 mg i.v.

  Study Day 8, 30 min pre till 5 hours post cocaine infusion

• Maximum Systolic Blood Pressure (After 40 mg i.v. Cocaine)

  Maximum Systolic Blood Pressure (mmHg) after cocaine infusion 40 mg i.v.

  Study Day 9, 30 min pre till 5 hours post cocaine infusion

• Maximum Diastolic Blood Pressure (After 20 mg i.v. Cocaine)

  Maximum Diastolic Blood Pressure (mmHg) after cocaine infusion 20 mg i.v.

  Study Day 8, 30 min pre till 5 hours post cocaine infusion

• Maximum Diastolic Blood Pressure (After 40 mg i.v. Cocaine)

  Maximum Diastolic Blood Pressure (mmHg) after cocaine infusion 40 mg i.v.

  Study Day 9, 30 min pre till 5 hours post cocaine infusion

Study Arms (2)

SXC-2023

EXPERIMENTAL

SXC-2023: 800mg once a day for 7 days

Drug: SXC-2023

SXC-2023 Placebo

PLACEBO COMPARATOR

Placebo: 800mg once a day for 7 days

Drug: SXC-2023 Placebo

Interventions

SXC-2023 DRUG

200 mg capsules

SXC-2023

SXC-2023 Placebo DRUG

200 mg capsules

SXC-2023 Placebo

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead
• Promentis Pharmaceuticals, Inc.: collaborator
• Altasciences Company Inc.: collaborator
• Technical Resources International, Inc.: collaborator

Study Sites (1)

Altasciences Clinical Kansas, Inc.

Overland Park, Kansas, 66212, United States

Location

Results Point of Contact

• Title: Jana Drgonova
• Organization: NIDA/NIH

jana.drgonova@nih.gov

3018275933

Study Officials

• Debra Kelsh, MD

  Altasciences Clinical Kansas, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: April 2, 2024
• Study Start: October 8, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: April 24, 2026
• Results First Posted: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Nov 29, 2026 (18 months after the database lock) Nov 29, 2036
• Access Criteria: Researchers whose request is approved by the Data Access Committee

Locations

US (1)