NCT04169360

Safety and Preliminary Efficacy of ANS-6637 to Reduce Drug Craving and Harm in People With Opioid Use Disorder

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a double blind, placebo controlled, randomized trial to evaluate the safety and preliminary efficacy of ANS-6637 in adults with opioid use disorder with and without opioid agonist therapy. Patients will be randomized to two arms: (1) ANS-6637 for three months vs (2) Placebo for three months. Subjects will subsequently be followed for an additional one month post treatment.

Detailed description

This is a double blind, placebo controlled, randomized trial to evaluate the safety and preliminary efficacy of ANS-6637 in adults with opioid use disorder with and without opioid agonist therapy. At screening, after providing consent, participants will be evaluated to ensure criteria for opioid use disorder by DSM V criteria is met, and whether the subject is receiving opioid agonist therapy will be determined. Participants will undergo a medical evaluation (including medical history, laboratory tests and EKG evaluation) to establish baseline medical and psychiatric diagnosis in order to ensure safety of participation. Once enrollment criteria are met, patients will be randomized in a blinded fashion to ANS-6637 or placebo, stratified by site and form of opioid agonist therapy. On Day 0, patients will be initiated on ANS-6637 vs. placebo according to randomization group. Subjects will be seen twice per week for two weeks, followed by weekly for two weeks, and then monthly for two months.

Conditions

• Opioid-use Disorder

Interventions

Type	Name	Description
DRUG	ANS-6637	White, oblong 300 mg tablet
DRUG	Placebo oral tablet	White, oblong 300 mg tablet

Timeline

• Start date: 2021-01-01
• Primary completion: 2021-01-12
• Completion: 2021-01-12
• First posted: 2019-11-19
• Last updated: 2021-01-28

Regulatory

• FDA-regulated drug study