Lorcaserin Intra Venous Cocaine Effects

• Status: Unknown status
• Trial end date: 2019-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, cross-over, single-blind, placebo-controlled, single-center, multiple-panel evaluation of the potential for oral lorcaserin to modify cocaine self-administration in a laboratory setting. To prevent unauthorized drug use, study medications will be administered as participants are confined during overnight stays at the Medical Center. Non-treatment-seeking, regular cocaine users will receive oral treatment with single doses of placebo, lorcaserin 10 mg (Panel 1), or lorcaserin 20 mg (Panel 2). Afterwards, the subjective and reinforcing effects of intravenous cocaine will be measured in a laboratory setting.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Midwest Biomedical Research Foundation
• Treatments: Cocaine

Criteria

Inclusion Criteria:

1. Is non-treatment-seeking and has used cocaine regularly for at least six months.

2. Has used cocaine by a rapid route of administration (smoked or intravenous injection), at least three times per week, for three of the preceding six weeks.

3. Is male or female, between 21 and 50 years old.

4. Is able to verbalize understanding of the consent form, able to provide written informed consent, and verbalize willingness to complete study procedures.

5. Is agreeable to the study schedule and likely to complete all interventions and measures.

6. Has a medical history, physical exam, and screening laboratory results that demonstrate no contraindication to participation.

Exclusion Criteria:

1. Has a history of a medical adverse reaction to cocaine or other psycho stimulants, including loss of consciousness, chest pain, cardiac ischemia, or seizure.

2. Has any current Axis I psychiatric disorder other than drug abuse or dependence.

3. Meets DSM-IV-TR criteria for dependence on opiates, benzodiazepines, alcohol, or other sedative-hypnotics.

4. Has received opiate-substitution therapy within two months prior to enrollment.

5. Has a current or past history of seizure disorder other than febrile seizures, including alcohol- or psycho stimulant- related seizures, or family history of seizure disorder.

6. Has a diagnosis of adult asthma or chronic obstructive pulmonary disease.

7. Has had head trauma that resulted in neurological sequelae (e.g., loss of memory for greater than 5 minutes).

8. Has a history of valvular heart disease, congestive heart failure, syncope, bradycardia, or any other cardiac condition.

9. Has a condition that increases the risk of cocaine-induced hypertension or ischemic heart disease, such as hypertension, hypercholesterolemia, renal disease (serum creatinine > 1.4 mg/dl), diabetes (fasting glucose level ≥ 100 mg/dl).

10. Has a history of jaundice, hepatitis, or laboratory evidence of hepatic insufficiency (total bilirubin ≥ 2.0, serum albumin ≤ 3.5 gm./dl); or current abnormalities of liver function testing with serologic evidence of hepatitis (serology and coagulation will be evaluated in individuals with aspartate transaminase or Alaine aminotransferase > 40 IU/L).

11. History of priapism or conditions that would predispose to priapism (sickle cell anemia, multiple myeloma, leukemia, Peyronie's disease, or other anatomical deformation of the penis).

12. Currently being treated for erectile dysfunction.

13. Has an unstable medical condition, which, in the judgment of investigators, would make participation hazardous, such as AIDS or active TB.

14. If female, is pregnant or lactating (nursing), not practicing adequate methods of contraception, or planning to become pregnant within one month of conclusion of the study.

15. Has current suicidal ideation as assessed by the SCID interview.

16. Has clinically significant ECG abnormalities, including QTc interval prolongation > 450 milliseconds in men or 480 milliseconds in women.

17. Has donated blood or participated in another clinical trial within 4 weeks of enrollment.

18. In the opinion of investigators, is expected to fail to complete the study protocol due to probable incarceration or relocation from the clinic area.

19. Has had known or suspected hypersensitivity to Lorcaserin.

20. Is currently being treated with an adrenergic receptor antagonist ('beta blocker').

21. Is currently receiving Lorcaserin, potential CYP2D substrates, or medications associated with the serotonin syndrome or neuroleptic-malignant syndrome (see Tables 8 and 9).

22. Has a significant potential for violent behavior, as assessed by the Structured Assessment of Violence Risk in Youth (SAVRY).23