NCT03813095

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

Nanoencapsulated Cannabidiol Time Released Capsules Targeted to Reduce Cravings in the Treatment of Opioid Addiction

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Aphios · Industry
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase 2a Exploratory Pilot study assessing the efficacy, immunogenicity and pharmacology of APH-1501, Cannabidiol (CBD), a unique, bioactive component of marijuana, in reducing early attrition and improving outcome in opioid-dependent individual in adults diagnosed with an opioid addiction, ages 21-55 years of age. Subjects will be randomized into 4 groups receiving APH-1501 or placebo over a 30 day period that includes a regimen of reformulated 400, 600 or 800 mg/m2 APH 1501 or placebo. This trial will target opioid-dependent patients who have completed detoxification and are in a treatment facility. During the trial period, participants will be given APH-1501 twice a day for 30 days. Given prior evidence based research on CBD there should be minimum to no side effects to taking APH 1501. The overarching research question for the study is the efficacy of APH 1501, pharmaceutical-grade CBD (\>98.5% and \< 0.3% Δ9-THC) for clinical use in the treatment of opioid addiction. This is an intervention model design with three treatment groups, parallel assignment. This study is designed for sufficient time in between dose escalations to allow for interim analysis of safety and tolerability data to be considered for the safest approach to assess the effects of the compound as a therapeutic agent. Randomization will be stratified by the Diagnostic and Statistical Manual (DSM)\_V diagnosis taking into account any co-morbid features or dual diagnosis.

Conditions

• Addiction
• Opioid Dependence
• Opioid Withdrawal

Interventions

Type	Name	Description
DRUG	APH-1501	The investigational drug product APH-1501 is CBD encapsulated in biodegradable polymer nanospheres, is a lyophilized powder intended for oral administration.
DRUG	Placebo	The placebo is a sterile pyrogen free lyophilized powder identical in appearance to the experimental drug product.

Timeline

• Start date: 2023-10-01
• Primary completion: 2025-09-01
• Completion: 2025-12-01
• First posted: 2019-01-23
• Last updated: 2021-07-27

Regulatory

• FDA-regulated drug study