Treatment With Lorcaserin for Cocaine Use: The TLC Study
Condition: Cocaine Use Disorder
Intervention: lorcaserin; Placebo Oral Tablet; Substance use counseling; ACASI; Cocaine metabolites; Ecological Momentary Assessment (EMA); Balloon Analogue Risk Task (BART); Qualitative Exit Interview
Intervention description: lorcaserin 20 mg tablet; placebo 20 mg. tablet; Manual-driven psychosocial substance use counseling program using cognitive behavioral therapy and motivational interviewing techniques and incorporating the Stages of Change Model.; Audio-computer assisted self-interviews (ACASI) is a self-administered standardized questionnaire on substance and alcohol use, substance use treatment, sexual risk behavior, partnership sexual risk, and; Rapid qualitative urine test Medtox Verdict II (Medtox Diagnostics, Burlington, NC) and tamper-evident sweat patches (PharmChek®, PharmChem, Inc., Fort Worth, Tx); EMA are questions sent to the participant 4-5 times a day to determine real-time behavior and participant experiences.; BART is a computerized measure of risk taking behavior. The BART models real-world risk behavior through the conceptual frame of balancing the potential for reward versus loss. This is a test for impulsivity.; The qualitative exit interview assessed acceptability measures and included questions on attitudes about trial participation, level of satisfaction with trial procedures, and trial medication.
Intervention MeSH terms: Cocaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 12-week parallel group pilot study with 2:1 random assignment to 20 mg of extended-release oral lorcaserin versus placebo
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 22.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: HIV; sexual behavior

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.
    

Eligibility 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 (Diagnostic and Statistical Manual of Mental Health Disorders
             (DSM-V) and Structured clinical interviews (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 complete blood count (CBC), total protein, albumin, glucose, alkaline
             phosphatase, creatinine, Blood Urea Nitrogen (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 T-cell count (CD4) count < 200 cells/mm3 ;

          -  moderate/sever liver disease (Aspartate Transferase (AST), Alanine Transaminase (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 Electrocardiogram (ECG) demonstrating Corrected QT interval (QTc) > 450 or a Q
             wave, R wave and S wave (QRS) interval > 120 msec at screening. If Fridericia (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).