Drug Interaction and Self Administration Studies of Compounds for Cocaine Use Disorder

• Status: Completed
• Trial end date: 2018-07-19
• Target enrollment: 0
• Participant gender: All

Summary

The overall goal of this project is to develop initial human data on effects of novel compounds on safety (interactions with cocaine) and efficacy (subjective response to cocaine and self administration data) in non-treatment seeking cocaine use disorder subjects. The compound to be studied will be the 5-HT2CR agonist lorcaserin. Lorcaserin and other 5-HT2CR agonists have been shown to reduce cocaine self-administration and cue reactivity in rodents. In addition there is human safety data in non-cocaine using subjects for lorcaserin as it is currently FDA approved for obesity, and safety data from a cocaine interaction study in rodents , but there is no human cocaine interaction/PK data and no PD data to support potential dosages for phase II clinical trials.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Commonwealth University
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Cocaine

Criteria

In order to participate in this study, subjects must:

1. Males and females between 18 and 59 years-of-age.

2. Understand the study procedures and provide written informed consent.

3. Meet current DSM-5 criteria for cocaine use disorder, at least moderate severity, and current DSM-IV diagnosis of cocaine dependence, but are not seeking treatment.

4. Currently using cocaine by smoking or intravenous route of administration as determined by self-report and have a positive urine drug screen for cocaine during screening.

5. Have vital signs as follows: resting pulse below 95 bpm, blood pressures below 140 mm Hg systolic and 90 mm Hg diastolic.

6. Have no clinically significant abnormalities in the judgment of the study physician in hematology and chemistry laboratory tests including liver function tests.

7. Have sinus rhythm with normal conduction (including QTcF less than 440 ms) by ECG.

8. Have no contraindications for study participation as determined by medical history and physical examination.

9. Be able to demonstrate an understanding of study procedures and follow instructions including behavioral laboratory testing.

10. 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.

11. Have hemoglobin/hematocrit values within normal limits based on age and gender.

In order to participate in the study, subjects must not:

1. Meet current DSM-5 diagnosis of any psychoactive substance use disorder other than cocaine, opiates, marijuana, or nicotine. Diagnosis of mild to moderate use disorder for alcohol will not be considered exclusionary.

2. Have a 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 cocaine, including loss of consciousness, chest pain, or epileptic seizure.

4. Have any clinically significant medical disorder including cardiovascular (including hypertension), pulmonary, CNS, hepatic, or renal disorder.

5. Have a history of seizures (excluding childhood febrile seizures), or loss of consciousness for more than 20 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 a positive breath alcohol test or urine drug screening positive for drugs of abuse with the exception of cocaine, opiates, cocaine metabolites, and marijuana.

13. Have a score greater than 5 on the Clinical Opiates Withdrawal Scale (COWS) on any screening, monitoring or hospital study visit.

14. Subjects who are allergic to lorcaserin.

15. Subjects who have taken any investigational drug within 90 days prior to baseline.