Treatment With Lorcaserin for Cocaine Use: The TLC Study (TLC)

August 9, 2023 updated by: Glenn-Milo Santos
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, double-blind, placebo-controlled, 12-week parallel group pilot study with 2:1 random assignment to 20 mg of extended-release oral lorcaserin versus placebo. Participants are recruited via street outreach, recruitment flyers, sexually transmitted diseases (STD) and HIV clinics, needle exchanges, community organizations, MSM bars, online Web sites, and social media. Potential participants complete a brief telephone screen to assess initial eligibility and, if eligible, are scheduled for an in-person screening visit. All participants give informed consent using University of California at San Francisco (UCSF) Institutional Review Board (IRB)-approved consent forms. A 10-item true/false questionnaire is used to verify participants' understanding of the trial. The target sample size for the study was 45 participants (The Food and Drug Administration (FDA) closed down the study early due to a long-term safety study showing that long term use of lorcaserin could be hazardous to your health). Only 22 of the 45 participants were randomized to the study.

With the proposed sample size, we estimate that proportions for our feasibility and acceptability outcomes would be estimated within margins of sampling error (Mean squared error (MSEs); i.e., half widths of 95% confidence intervals) of ≤14.4 percentage points, and means with MSEs of 0.30 standard deviations, both typical for a small pilot study.

Participants are screened for eligibility based on inclusion criteria. At Enrollment, participants are instructed to take one pill each day of extended-release lorcaserin 20mg or placebo. Medications are dispensed in bottles with Medication Events Monitoring (MEMS) caps, which are wireless medication monitoring devices that record each opening as a real-time medication event. All participants are asked about potential adverse events at each follow-up visit; symptom-driven physical exams and safety laboratory monitoring are done at weeks 4, 8, and 12. Adverse events are classified using the Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences for HIV Prevention Trials Network. Participants are seen every week for substance use counseling and urine tests for cocaine metabolites. Trained staff, supervised by a clinical psychologist, administered brief (20-30 minutes) substance use counseling at follow-up visits. Audio-computer assisted self-interviews (ACASI) are used to standardize data collection and minimize reporting bias. Standardized measures are used to assess drug and alcohol use using timeline followback, substance use treatment, craving and severity of cocaine dependence, and sexual risk behavior. Acceptability measures include questions on attitudes about trial participation, level of satisfaction with trial procedures, and trial medication.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94102
        • San Francisco Department of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Experimental
lorcaserin, extended release, Substance use counseling, ACASI behavioral questionnaire, BART, and ecological momentary assessment
Drug: lorcaserin
lorcaserin 20 mg tablet
Other Names:
  • BELVIQ
Behavioral: Substance use counseling
Manual-driven psychosocial substance use counseling program using cognitive behavioral therapy and motivational interviewing techniques and incorporating the Stages of Change Model.
Behavioral: ACASI
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
Diagnostic test: Cocaine metabolites
Rapid qualitative urine test Medtox Verdict II (Medtox Diagnostics, Burlington, NC) and tamper-evident sweat patches (PharmChek®, PharmChem, Inc., Fort Worth, Tx)
Behavioral: Ecological Momentary Assessment (EMA)
EMA are questions sent to the participant 4-5 times a day to determine real-time behavior and participant experiences.
Other Names:
  • EMA
Behavioral: Balloon Analogue Risk Task (BART)
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.
Other Names:
  • BART
Behavioral: Qualitative Exit Interview
The qualitative exit interview assessed acceptability measures and included questions on attitudes about trial participation, level of satisfaction with trial procedures, and trial medication.
Placebo Comparator: Control
Placebo, Substance use counseling, ACASI behavioral questionnaire, BART, and ecological momentary assessment
Drug: Placebo Oral Tablet
placebo 20 mg. tablet
Other Names:
  • Placebo
Behavioral: Substance use counseling
Manual-driven psychosocial substance use counseling program using cognitive behavioral therapy and motivational interviewing techniques and incorporating the Stages of Change Model.
Behavioral: ACASI
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
Diagnostic test: Cocaine metabolites
Rapid qualitative urine test Medtox Verdict II (Medtox Diagnostics, Burlington, NC) and tamper-evident sweat patches (PharmChek®, PharmChem, Inc., Fort Worth, Tx)
Behavioral: Ecological Momentary Assessment (EMA)
EMA are questions sent to the participant 4-5 times a day to determine real-time behavior and participant experiences.
Other Names:
  • EMA
Behavioral: Balloon Analogue Risk Task (BART)
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.
Other Names:
  • BART
Behavioral: Qualitative Exit Interview
The qualitative exit interview assessed acceptability measures and included questions on attitudes about trial participation, level of satisfaction with trial procedures, and trial medication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Percentage of Weekly Follow-up Visits of Randomized Study Participants
Time Frame: 12 weeks
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)
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glenn-Milo Santos

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Glenn-Milo Santos, PhD, MPH, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

February 28, 2020

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

June 12, 2017

First Submitted That Met QC Criteria

June 19, 2017

First Posted (Actual)

June 20, 2017

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 9, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-21502
  • 1R34DA042161 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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