Clinical Trials Logo

Clinical Trial Summary

The primary objective of this study is to assess the safety and tolerability of a single day dosing and a separate multiple day dosing of 18-MC HCl administered orally, each part of the study having a different set of healthy male and female volunteers.


Clinical Trial Description

This is a Phase 1, double-blind, randomized, placebo-controlled, single day and multiple day dosing, in healthy, non-smoking, male and female volunteers. Part 1: Single Ascending Dose (SAD) Seven (7) healthy male and female volunteers will be randomly assigned to receive either 18-MC HCl (n=5) or placebo (n=2) in each cohort. These volunteers will receive 18-MC HCl twice in 1 day (bid). There are 3 phases: Screening, Enrollment and Follow-Up. All participants will be assessed for safety and tolerability for 28 days. Screening begins when a participant reports to the clinical unit (CU) for a screening visit to undergo safety and compliance assessments on this day. Participants that meet all eligibility criteria will be admitted to the CU on the day prior to receiving study drug. Enrollment begins on Day 1 where participants will receive two doses of study drug for 1 day, will be assessed for 18-MC PK up to 48 hours, and will remain admitted at the CU until Day 3, at which time they will be discharged. For follow-up the participants will return for safety and tolerability assessments at Days 7, 14, 21 and Day 28. Part 2: Multiple Day Ascending Dose (MAD) Seven (7) healthy male and female volunteers will be randomly assigned to receive either 18-MC HCl (n=5) or placebo (n=2) in each cohort. These volunteers will receive 18-MC HCl twice over 7 days (bid). There are 3 phases: Screening, Enrollment and Follow-Up. All participants will be assessed for 42 days. Screening begins when a participant reports to the clinical unit (CU) for a screening visit to undergo safety and compliance assessments on this day. Participants that meet all eligibility criteria will be admitted to the CU on the day prior to receiving study drug. Enrollment begins on Day 1 where participants will receive two doses of study drug every day for 7 days, will be assessed for 18-MC PK up to 48 hours on Day 1 and Day 7, and will remain admitted at the CU until Day 9, at which time they will be discharged. For follow-up the participants will return for safety and tolerability assessments at Days 14, 21, 28, 35 and Day 42. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04292197
Study type Interventional
Source Mind Medicine, Inc.
Contact
Status Completed
Phase Phase 1
Start date April 14, 2020
Completion date December 31, 2021

See also
  Status Clinical Trial Phase
Terminated NCT03576768 - QuitFast: Evaluating Transcranial Magnetic Stimulation as a Tool to Reduce Smoking Directly Following a Quit Attempt N/A
Completed NCT04110626 - Realistic Evaluation of Expériences Animées, a School-based Intervention in Nouvelle Aquitaine
Completed NCT03007940 - Using NIATx Strategies to Implement Integrated Services in Routine Care N/A
Not yet recruiting NCT04030858 - The INFINITE Study: A Prospective Investigation of a Nutrient-dense Diet in Early Addiction Recovery N/A
Completed NCT03347643 - The Effectiveness of tDCS on Internet Game Addiction Phase 2
Active, not recruiting NCT02836080 - Integrated Collaborative Care Teams for Youth With Mental Health and/or Addiction Challenges (YouthCan IMPACT) N/A
Completed NCT03221985 - ESM Pilot: Mobile Phones and Psychology N/A
Completed NCT02556060 - Lamotrigine for Ketamine Dependence Trial Phase 2/Phase 3
Completed NCT02812810 - Evaluation of the Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) Low-frequency on Craving in Smoking Dependence N/A
Completed NCT01531153 - Cognitive Enhancement as a Target for Cocaine Pharmacotherapy N/A
Recruiting NCT05976646 - Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion Phase 1/Phase 2
Completed NCT04409106 - The Turkish Version of the Parental Smartphone Use Management Scale (PSUMS)
Not yet recruiting NCT06459609 - Effect of Protein Supplementation on Craving in Subjects Hospitalised for Addiction Treatment N/A
Recruiting NCT05595759 - Violence Against Women in Patients With Alcohol Substance Addiction Training N/A
Completed NCT04099173 - A Brief Mindfulness-Based Intervention for Suicidal Ideation N/A
Recruiting NCT04959643 - Systematic Screening for Viral Hepatitis B and C at the PASS Consultation of the Montpellier University Hospital
Completed NCT04133688 - Mobile App in Addiction N/A
Recruiting NCT04063267 - Electronic Cigarettes as a Harm Reduction Strategy in Individuals With Substance Use Disorder Phase 2
Completed NCT05114577 - Recovery Sleepers: A Pilot Study of a Sleep Health Intervention for College Students in Recovery N/A
Terminated NCT02671240 - Prognosis of Behavioral Addiction in Parkinson's Disease