Drug Interaction and Subjective Effects of Compounds for Opioid Use Disorder

NCT03143855 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: HM20008062U54DA038999
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of this project is to develop initial human data on effects of novel compounds on safety (interactions with oxycodone) and efficacy (subjective response to oxycodone) in non-treatment seeking opioid use disorder subjects. The compound to be studied will be the 5-HT2CR agonist lorcaserin. There are no known or reported adverse interactions between lorcaserin and oxycodone or other opioids.

Conditions

Opioid Abuse; Opioid Dependence; Opioid-Related Disorders; Opioid Use

Keywords

oxycodone; lorcaserin; Belviq

Outcome Measures

Primary Outcomes (1)

• Change in Subjective Response to Oxycodone Measured With 100 Millimeter Visual Analog Scale

  Drug liking is measured on a 100 millimeter visual analog rating with one end of the line representing a score of 0 for "not at all" and the other end being a score of 100 or extremely. Participants complete the rating 45 minutes after a 20 mg dose of oxycodone at baseline and after after 5 days of treatment.

  Baseline to day 5

Study Arms (2)

Lorcaserin

EXPERIMENTAL

Drug: Lorcaserin

Control Group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Lorcaserin DRUG

Lorcaserin will be administered at a dose of 10 mg twice daily for 5 days

Lorcaserin

Placebo DRUG

Placebo will be administered twice daily for for 5 days

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to participate in this study, subjects must:
• Males and females between 18 and 70 years-of-age.
• Understand the study procedures and provide written informed consent.
• Meet current DSM-5 criteria for opioid use disorder, at least moderate severity, but are not seeking treatment.
• Have at least one positive urine drug screen for opioids during screening to document opioid use.
• Have no clinically significant abnormalities in the judgment of the study physician in hematology and chemistry laboratory tests including liver function tests.
• Have no contraindications for study participation as determined by medical history and physical examination.
• Be able to demonstrate an understanding of study procedures and follow instructions including behavioral laboratory testing.
• No pregnant or nursing women will be permitted in the study, and women must either be unable to conceive (i.e., surgically sterilized, sterile, or postmenopausal) or be using a reliable form of contraception (e.g., abstinence, birth control pills, intrauterine device with spermicide, or condoms). Men will be advised to use condoms. All females must provide negative pregnancy urine tests before study entry, at each visit during the study, and at the end of study participation.

You may not qualify if:

• In order to participate in the study, subjects must not:
• Have a current DSM-5 axis I psychiatric disorder other than substance use disorder including but not limited to Bipolar Disorder, Major Depressive Disorder, ADHD, or Schizophrenia or a neurological disorder requiring ongoing treatment and/or making study participation unsafe.
• Have any previous medically adverse reaction to oxycodone or other opioids or lorcaserin.
• Have any untreated clinically significant medical disorder including cardiovascular, pulmonary, CNS, hepatic, or renal disorder.
• Have a history of seizures (excluding childhood febrile seizures), or loss of consciousness from traumatic injury for more than 30 minutes.
• Have significant current suicidal or homicidal ideation or a history of suicide attempt within the past 6 months.
• Have conditions of probation or parole requiring reports of drug use to officers of the court.
• Have impending incarceration.
• Have a positive HIV test by self-report or history.
• Be pregnant or nursing or not using a reliable form of contraception if able to conceive. All females must provide negative pregnancy urine tests at screening, and daily after hospital admission.
• Have any other illness, or condition, which in the opinion of the PI would preclude safe and/or successful completion of the study.
• Have taken any investigational drug within 90 days prior to baseline.
• Have an allergy to lorcaserin or oxycodone.
• Have taken or are currently taking drugs that are know to inhibit cytochrome P450, CYP3A or CYP2D6.
• ECG with QTc \> 440ms.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

lorcaserin

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. F. Gerard Moeller
• Organization: Virginia Commonwealth University

fgmoeller@vcu.edu

804-828-4134

Study Officials

• Frederick G Moeller, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 8, 2017
• Study Start: January 30, 2017
• Primary Completion: April 5, 2019
• Study Completion: April 5, 2019
• Last Updated: November 12, 2020
• Results First Posted: November 12, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)