Treatment With Lorcaserin for Cocaine Use: The TLC Study

• Status: Terminated
• Trial end date: 2020-06-30
• Target enrollment: 0
• Participant gender: Male

Summary

This project is a placebo-controlled, double-blind randomized trial evaluating the feasibility, tolerability, acceptability and adherence for lorcaserin among actively using, men who have sex with men (MSM) with cocaine use disorders.The study will enroll 45 individuals who will randomly be assigned to either the treatment (lorcaserin) arm or the placebo arm, to be taken twice a day for 12 weeks.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Glenn-Milo Santos; University of California, San Francisco
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Cocaine

Criteria

Inclusion Criteria:

• Male gender assigned at birth and transgender men;

• self-reported anal intercourse with men in the prior six months while under the influence of cocaine;

• cocaine use disorder by DSM-V SCID criteria;

• current cocaine use confirmed by urinalysis and cocaine use at least 15 days in the past 30 days;

• HIV-negative by rapid test or HIV-positive with a medical record of HIV infection;

• no current acute illnesses requiring prolonged medical care;

• no chronic illnesses that are likely to progress clinically during trial;

• able and willing to provide informed consent and adhere to visit schedule;

• age 18-65 years;

• baseline CBC, total protein, albumin, glucose, alkaline phosphatase, creatinine, BUN, and electrolytes without clinically significant abnormalities as determined by study clinician in conjunction with symptoms, physical exam, and medical history

Exclusion Criteria:

• Any psychiatric condition (e.g., depression with suicidal ideation, schizophrenia) or medical condition that would preclude safe study participation;

• HIV-positive test result at screening visit but previously unaware of HIV infection (i.e., newly diagnosed with HIV infection at screening; those with a medical record of HIV infection are eligible);

• any moderate to severe alcohol or substance use disorders (other than cocaine use disorders), according to DSM-V criteria;

• known allergy or previous adverse reaction to lorcaserin;

• current CD4 count < 200 cells/mm3 ;

• moderate/sever liver disease (AST, ALT > 3 times upper limit or normal);

• severely impaired renal function (creatinine clearance £ 30 ml/min);

• use of medications that affect the serotonergic neurotransmitter system (e.g., selective serotonin reuptake inhibitors (SSRIs), selective serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs));

• predisposition to priapism;

• currently participating in another longitudinal intervention research study;

• body mass index (BMI) < 15; or ≥ 30 with desire to use weight management medication, or BMI > 35;

• anticipated use of agents that are associated with valvulopathy and/or pulmonary hypertension

• Are currently treated with an opiate-substitute (buprenorphine or methadone) maintenance treatment or received therapy with any opiate-substitute within 30 days preceding screening

• Currently in court-mandated cocaine use treatment;

• Had previous history of suicidal behavior in the last 12 months ("yes" answer to the suicidal behavior question 6 of the Columbia-Suicide Severity Rating Scale (C-SSRS)); or currently have suicidal ideation as determined by 'yes' answers to questions 4 or 5 on the C-SSRS administered by a study clinician;

• Any physical condition affecting drug absorption (e.g., gastrectomy);

• 12-lead ECG demonstrating QTc > 450 or a QRS interval > 120 msec at screening. If QTcF exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTc values should be used to determine the subject's eligibility.

(Note: Participants newly diagnosed with HIV at screening who consent to be contacted for re-screening will be called in the subsequent month, or later, depending on participant preference).