Clinical Trials Logo
  1. Home
  2. Opioid Dependence
  3. NCT03813095

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

Opioid Dependence Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03813095
Study type Interventional
Source Aphios
Contact Trevor P Castor
Phone 7819326933
Email tcastor@aphios.com
Status Not yet recruiting
Phase Phase 2
Start date October 2023
Completion date December 2025
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT03675386 - Reducing Opioid Use for Chronic Pain Patients Following Surgery N/A
Completed NCT02593474 - Medication-Assisted Treatment for Youth With Substance Use Disorders Phase 1
Completed NCT02282306 - Phone Interview to Prevent Recurring Opioid Overdoses N/A
Completed NCT02294253 - Buprenorphine/Naloxone Stabilization and Induction Onto Injection Naltrexone Phase 2/Phase 3
Completed NCT01592461 - Starting Treatment With Agonist Replacement Therapies Follow-up Study N/A
Terminated NCT00768482 - A Bioavailability and Safety Study of Probuphine Versus Sublingual Buprenorphine in Patients With Opioid Dependence Phase 3
Completed NCT01741350 - Testing a Community-Friendly Risk Reduction Intervention for Injection Drug Users N/A
Terminated NCT04121546 - Collaborative Care for Opioid Dependence And Pain Pilot Study N/A
Withdrawn NCT03368794 - Naloxone to TReatment Entry in the Emergency Setting N/A
Completed NCT03447743 - Re-entry XR-NTX for Rural Individuals With Opioid Use Disorder Early Phase 1
Completed NCT04464421 - SMART Effectiveness Trial N/A
Recruiting NCT04189523 - Does Early Administration of Ultrasound Guided Regional Anesthesia for Long Bone Fractures Effect Long Term Patient Opioid Usage N/A
Completed NCT03305666 - Trial of Injected Liposomal Bupivacaine vs Bupivacaine Infusion After Surgical Stabilization of Rib Fractures Phase 4
Recruiting NCT04003948 - Preliminary Efficacy and Safety of Ibogaine in the Treatment of Methadone Detoxification Phase 2
Terminated NCT02935101 - Effects of Glucocorticoids on Craving During Detoxification Treatment of Heroin and/or Stimulants Phase 2
Completed NCT01895270 - Improving Buprenorphine Detoxification Outcomes With Isradipine Phase 1/Phase 2
Completed NCT01717963 - Naltrexone vs Buprenorphine-Naloxone for Opioid Dependence in Norway Phase 3
Completed NCT01425060 - Improving Effective Contraceptive Use Among Opioid-maintained Women Phase 1
Completed NCT02324725 - Biomarkers of Injectable Extended Release Naltrexone Treatment Phase 4
Completed NCT01262092 - Effects of Gabapentin Versus Placebo on Buprenorphine Detoxification of Opioid-dependent Individuals Phase 2