Drug Interaction and Subjective Effects of Compounds for Opioid Use Disorder
Condition: Opioid Abuse; Opioid Dependence; Opioid-Related Disorders; Opioid Use
MeSH terms: Opioid-Related Disorders
Intervention: Lorcaserin; Placebo
Intervention description: Lorcaserin will be administered at a dose of 10 mg twice daily for 5 days; Placebo will be administered twice daily for for 5 days
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: oxycodone; lorcaserin; Belviq

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.
    

Eligibility criteria:

        Inclusion Criteria:

        In order to participate in this study, subjects must:

          1. Males and females between 18 and 70 years-of-age.

          2. Understand the study procedures and provide written informed consent.

          3. Meet current DSM-5 criteria for opioid use disorder, at least moderate severity, but
             are not seeking treatment.

          4. Have at least one positive urine drug screen for opioids during screening to document
             opioid use.

          5. Have no clinically significant abnormalities in the judgment of the study physician in
             hematology and chemistry laboratory tests including liver function tests.

          6. Have no contraindications for study participation as determined by medical history and
             physical examination.

          7. Be able to demonstrate an understanding of study procedures and follow instructions
             including behavioral laboratory testing.

          8. 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.

        Exclusion Criteria:

        In order to participate in the study, subjects must not:

          1. Meet current DSM-5 diagnosis of any psychoactive substance use disorder other than
             opioids, marijuana, cocaine or nicotine. Diagnosis of mild to moderate use disorder
             for alcohol will not be considered exclusionary (SCID).

          2. 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.

          3. Have any previous medically adverse reaction to oxycodone or other opioids or
             lorcaserin.

          4. Have any untreated clinically significant medical disorder including cardiovascular,
             pulmonary, CNS, hepatic, or renal disorder.

          5. Have a history of seizures (excluding childhood febrile seizures), or loss of
             consciousness from traumatic injury for more than 30 minutes.

          6. Have significant current suicidal or homicidal ideation or a history of suicide
             attempt within the past 6 months.

          7. Have conditions of probation or parole requiring reports of drug use to officers of
             the court.

          8. Have impending incarceration.

          9. Have a positive HIV test by self-report or history.

         10. 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.

         11. Have any other illness, or condition, which in the opinion of the PI would preclude
             safe and/or successful completion of the study.

         12. Have taken any investigational drug within 90 days prior to baseline.

         13. Have an allergy to lorcaserin or oxycodone.

         14. Have taken or are currently taking drugs that are know to inhibit cytochrome P450,
             CYP3A or CYP2D6.

         15. ECG with QTc > 440ms.