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

Launched by APHIOS · Jan 18, 2019

Keywords

ClinConnect Summary

This clinical trial is looking at a new medication called APH-1501 to see if it is safe and effective for people struggling with opioid addiction. The main goal is to find out how different doses of this drug can help individuals who are dependent on opioids, which are strong pain medications that can lead to addiction. The trial is currently not recruiting participants, but when it begins, it will focus on adults aged 21 to 55 who meet specific criteria for substance use disorder.

To participate, individuals must be willing to stay in a study unit for the entire treatment period and follow certain rules regarding food, drink, and other medications. They should not be pregnant or breastfeeding and must not have taken any opioids or certain psychiatric medications recently. Participants will be randomly assigned to receive the medication and will need to provide written consent before joining the study. Overall, this trial aims to explore a potential new option for helping those affected by opioid dependence.

Gender

ALL

Eligibility 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.