Treatment With Lorcaserin for Cocaine Use: The TLC Study

NCT03192995 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: 17-215021R34DA042161
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cocaine Use Disorder

Keywords

HIV; sexual behavior

Outcome Measures

Primary Outcomes (5)

• Mean Percentage of Weekly Follow-up Visits of Randomized Study Participants

  To determine the feasibility of retaining individuals on lorcaserin vs. placebo, the investigators have calculated the mean weekly percentage of follow-up visits of those randomized in the study

  12 weeks

• Adverse Clinical Events in the Lorcaserin and Placebo Arms (Descriptive)

  To explore the tolerability of lorcaserin vs. placebo the investigators will compute the number of adverse events, both overall and by type. A participant could have more than one AE.

  12 weeks

• Cumulative Percent Adherence of Medication Events Monitoring (MEMs) Cap

  To evaluate the adherence of lorcaserin vs. placebo, the investigators measured adherence as the frequency of taking the study drug as measured by the number of MEMS cap openings (wireless medication monitoring devices that record each opening as a real-time medication event). Cumulative percent adherence was calculated by dividing the frequency of openings at a given time point divided by the number of days since baseline.

  12 weeks

• Proportion of Self-reported Past Week Cocaine Use Among Lorcaserin and Placebo Groups at Baseline and at 12 Weeks

  The outcome measure determines the proportion of self-reported past week cocaine use by Time-Line-Follow-back (TLFB) among lorcaserin and placebo groups at Baseline and at 12 weeks.

  12 weeks

• Proportion of Urine-positive Samples With Cocaine Positivity Among Lorcaserin and Placebo Groups at Baseline and at Week 12

  The outcome measure determines the proportion of urine-positive samples with cocaine positivity among lorcaserin and placebo groups at Baseline and at Week 12

  Week 12

Study Arms (2)

Experimental

ACTIVE COMPARATOR

lorcaserin, extended release, Substance use counseling, ACASI behavioral questionnaire, BART, and ecological momentary assessment

Drug: lorcaserin; Behavioral: Substance use counseling; Behavioral: ACASI; Diagnostic Test: Cocaine metabolites; Behavioral: Ecological Momentary Assessment (EMA); Behavioral: Balloon Analogue Risk Task (BART); Behavioral: Qualitative Exit Interview

Control

PLACEBO COMPARATOR

Placebo, Substance use counseling, ACASI behavioral questionnaire, BART, and ecological momentary assessment

Drug: Placebo Oral Tablet; Behavioral: Substance use counseling; Behavioral: ACASI; Diagnostic Test: Cocaine metabolites; Behavioral: Ecological Momentary Assessment (EMA); Behavioral: Balloon Analogue Risk Task (BART); Behavioral: Qualitative Exit Interview

Interventions

lorcaserin DRUG

lorcaserin 20 mg tablet

Also known as: BELVIQ

Experimental

Placebo Oral Tablet DRUG

placebo 20 mg. tablet

Also known as: Placebo

Control

Substance use counseling BEHAVIORAL

Manual-driven psychosocial substance use counseling program using cognitive behavioral therapy and motivational interviewing techniques and incorporating the Stages of Change Model.

Control; Experimental

ACASI BEHAVIORAL

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

Control; Experimental

Cocaine metabolites DIAGNOSTIC_TEST

Rapid qualitative urine test Medtox Verdict II (Medtox Diagnostics, Burlington, NC) and tamper-evident sweat patches (PharmChek®, PharmChem, Inc., Fort Worth, Tx)

Control; Experimental

Ecological Momentary Assessment (EMA) BEHAVIORAL

EMA are questions sent to the participant 4-5 times a day to determine real-time behavior and participant experiences.

Also known as: EMA

Control; Experimental

Balloon Analogue Risk Task (BART) BEHAVIORAL

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.

Also known as: BART

Control; Experimental

Qualitative Exit Interview BEHAVIORAL

The qualitative exit interview assessed acceptability measures and included questions on attitudes about trial participation, level of satisfaction with trial procedures, and trial medication.

Control; Experimental

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Glenn-Milo Santos: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

San Francisco Department of Public Health

San Francisco, California, 94102, United States

Location

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  PMID: 34265007 RESULT

MeSH Terms

Conditions

Sexual Behavior

Interventions

lorcaserin; Ecological Momentary Assessment

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Limitations and Caveats

The study was terminated early by the FDA due to the publication of a long-term safety study that showed an increase risk for cancer by the lorcaserin arm.

Results Point of Contact

• Title: Dr. Glenn-Milo Santos, Associate Professor
• Organization: University of California at San Francisco

glenn-milo.santos@ucsf.edu

415-867-1151

Study Officials

• Glenn-Milo Santos, PhD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Research Scientist

Model Details: 12-week parallel group pilot study with 2:1 random assignment to 20 mg of extended-release oral lorcaserin versus placebo

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: June 20, 2017
• Study Start: January 1, 2018
• Primary Completion: February 28, 2020
• Study Completion: June 30, 2020
• Last Updated: August 14, 2023
• Results First Posted: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)