MCAM for Opioid Use Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical trial is to test the safety and to see if there are any side effects of the investigational drug, MCAM. The main questions are:
1. To measure blood levels of the study drug after oral administration
2. To test how quickly the study drug starts working and how long it works for
Researchers will compare the active study drug to a placebo to test for any differences between the two groups.
Part A (Single increasing dose):
Participants will be screened for up to 28 days before starting study treatment. Following the screening visit, participants will be admitted to a clinic for 2 days for treatment with either the study drug or placebo. They will attend a follow-up visit on Day 5 and participate in a follow-up phone call on Day 8. Three different doses will be tested to find the highest safe dose.
Part B (Opioid-experienced group):
Participants will be screened for up to 28 days followed by a 10-day in-clinic dosing and assessment period. They will also participate in a follow-up phone call on Day 13. The study drug will be given to participants on Day 2, based on results from Part A.
Who Is on the Research Team?
Benjamin Sundling, DO
Principal Investigator
Dr. Vince Clinical Research
Are You a Good Fit for This Trial?
This trial is for healthy adults aged 18-55. For Part A, participants must be nonsmokers with a BMI between 18 and 32, weigh at least 50 kg, and have normal blood pressure and heart function. Part B includes adults who have experience using opioids.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part A
Participants receive single ascending doses of MCAM or placebo over a 2-day in-clinic period
Follow-up Part A
Participants attend a follow-up visit on Day 5 and a follow-up phone call on Day 8
Treatment Part B
Opioid-experienced participants receive placebo on Day 1 and MCAM on Day 2 during a 10-day in-clinic period
Follow-up Part B
Participants participate in a follow-up phone call on Day 13
What Are the Treatments Tested in This Trial?
Interventions
- MCAM
Trial Overview
The study tests the safety of MCAM (an investigational drug) compared to placebo in healthy adults and opioid-experienced individuals. It looks at how the body processes MCAM, its side effects, how quickly it works, and how long its effects last.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
Placebo will be dosed orally on Day 1 and MCAM will be dosed orally on Day 2. The dose level will be chosen based on the results of Part A (SAD).
MCAM will be dosed orally using 3 dose levels: 3, 10 and 30 mg free base on Day 1.
Participants in Part A randomized to placebo will receive 1% methylcellulose suspension on Day 1.
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Health Science Center at San Antonio
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
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