Exploratory Dose Ranging Study Assessing APH-1501 for the Treatment of Opioid Addiction

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is determine the safety, efficacy and tolerability of a novel drug APH-1501 as a pharmacotherapy for Opioid Dependence. The investigators will evaluate the safety of escalating doses APH-1501.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aphios
• Treatments: Analgesics, Opioid; Neurotransmitter Uptake Inhibitors

Criteria

Inclusion Criteria:

• Ages Eligible for Study: 21 to 55 Years (Adult)

• Sexes Eligible for Study: All

• Accepts Healthy Volunteers: No

• Meets DSM-V criteria with a Substance Use Disorder

• Meets protocol-specified criteria for qualification and contraception

• Must consent to random assignment, and be willing to commit to medication ingestion.

• Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related food, drink and medications

• Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

Exclusion Criteria:

• Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

1. the safety or well-being of the participant or study staff;

2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding);

3. the analysis of results

• Individuals with clinically significant medical disorders or lab abnormalities.

• History of cardiovascular events, head trauma or seizures

• Use of any psychoactive drug or medication at any time of study enrollment and participation

• Having taken any opioid medication in the last 14 days

• Concomitant use of psychotropic medications, with the exception of stable doses (defined as no dosing adjustments in the past two months) of non-monoamine oxidase inhibitor (MAO-I) (antidepressants, non-benzodiazepine anxiolytics, and Attention Deficit -Hyperactivity Disorder(ADHD) medications.

• Pregnant or breastfeeding

• Not using appropriate contraceptive measures ( hormonal, Nuvo-ring, Depo-Provera, IUD) or other barrier protection.

• Psychiatric condition as defined by the DSM-V - Lifetime history of DSM-5 Bipolar I or II Disorder, Schizophrenia or other psychotic disorder. Stably treated Major Depressive Disorder (MDD), Dysthymia, Generalized Anxiety Disorder (GAD), Social Phobia, and Specific Phobia diagnoses are acceptable (i.e. same dose of medication has been prescribed for at least 2 months prior to screening and no changes in current medication expected during course of the trial).

• Hypersensitivity to cannabinoids

• Suicidal ideation or behavior within the past 6 months. Subjects who are believed to be at suicidal or homicidal risk (answers 'yes' on questions 4 or 5 of C-SSRS) will be referred for assessment by a qualified mental health professional.

• Individuals taking an investigational agent within the last 30 days before baseline visit.