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Cocaine Use DisorderPhase 2TLCNCT03192995

Treatment With Lorcaserin for Cocaine Use: The TLC Study

A Phase 2 study testing lorcaserin, Substance use counseling and ACASI in people with Cocaine Use Disorder, run by Glenn-Milo Santos at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years, men only
Conditions the study is for
Cocaine Use Disorder
What is being tested?
lorcaserin, Substance use counseling and ACASI
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
22 participants
Where
1 siteUnited States
Study dates
1 Jan 2018to 30 Jun 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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

Who cannot join

  • 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);
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  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • San Francisco Department of Public Health

    San Francisco, California, 94102

Other trials in United States

About this study

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.

Read the 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.

Being tested
lorcaserin, Placebo Oral Tablet, Substance use counseling, ACASI, Cocaine metabolites
Keywords
HIV, sexual behavior
Medical subject headings
Sexual Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lorcaserinDrug

    Also called BELVIQ

    lorcaserin 20 mg tablet

  • Placebo Oral TabletDrug

    Also called Placebo

    placebo 20 mg. tablet

  • Substance use counselingBehavioural

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

  • ACASIBehavioural

    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

  • Cocaine metabolitesDiagnostic test

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

  • Ecological Momentary Assessment (EMA)Behavioural

    Also called EMA

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

  • Balloon Analogue Risk Task (BART)Behavioural

    Also called 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.

  • Qualitative Exit InterviewBehavioural

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

Study groups in NCT03192995
Study groupRoleWhat they receive
ExperimentalActive comparatorlorcaserin, extended release, Substance use counseling, ACASI behavioral questionnaire, BART, and ecological momentary assessment
Receives: 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
ControlPlacebo comparatorPlacebo, Substance use counseling, ACASI behavioral questionnaire, BART, and ecological momentary assessment
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 weeks

  2. 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.

    Measured: 12 weeks

  3. 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.

    Measured: 12 weeks

  4. 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.

    Measured: 12 weeks

  5. 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

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2017
  2. Study start1 Jan 2018
  3. Primary completion28 Feb 2020
  4. Study completion30 Jun 2020

Why it stopped: FDA alert regarding study drug safety

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Care provider, Investigator
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03192995
Sponsor's protocol ID
17-21502
Other IDs
1R34DA042161
Acronym
TLC
Status last verified
Aug 2023
First submitted
12 Jun 2017
Last updated
14 Aug 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Riezzo I, Fiore C, De Carlo D, Pascale N, Neri M, Turillazzi E, Fineschi V. Side effects of cocaine abuse: multiorgan toxicity and pathological consequences. Curr Med Chem. 2012;19(33):5624-46. doi: 10.2174/092986712803988893.

    PubMed 22934772

  • Karila L, Petit A, Lowenstein W, Reynaud M. Diagnosis and consequences of cocaine addiction. Curr Med Chem. 2012;19(33):5612-8. doi: 10.2174/092986712803988839.

    PubMed 22856661

  • Crane EH. Highlights of the 2011 Drug Abuse Warning Network (DAWN) Findings on Drug-Related Emergency Department Visits. 2013 Feb 22. In: The CBHSQ Report. Rockville (MD): Substance Abuse and Mental Health Services Administration (US); 2013-. Available from http://www.ncbi.nlm.nih.gov/books/NBK384680/

    PubMed 27631059

  • Degenhardt L, Baxter AJ, Lee YY, Hall W, Sara GE, Johns N, Flaxman A, Whiteford HA, Vos T. The global epidemiology and burden of psychostimulant dependence: findings from the Global Burden of Disease Study 2010. Drug Alcohol Depend. 2014 Apr 1;137:36-47. doi: 10.1016/j.drugalcdep.2013.12.025. Epub 2014 Jan 27.

    PubMed 24559607

  • Vandhuick O, Pistorius MA, Jousse S, Ferreira-Maldent N, Guilmot JL, Guias B, Bressollette L. [Drug addiction and cardiovascular pathologies]. J Mal Vasc. 2004 Dec;29(5):243-8. doi: 10.1016/s0398-0499(04)96768-6. French.

    PubMed 15738835

  • Kloner RA, Hale S, Alker K, Rezkalla S. The effects of acute and chronic cocaine use on the heart. Circulation. 1992 Feb;85(2):407-19. doi: 10.1161/01.cir.85.2.407.

    PubMed 1346509

  • McCord J, Jneid H, Hollander JE, de Lemos JA, Cercek B, Hsue P, Gibler WB, Ohman EM, Drew B, Philippides G, Newby LK; American Heart Association Acute Cardiac Care Committee of the Council on Clinical Cardiology. Management of cocaine-associated chest pain and myocardial infarction: a scientific statement from the American Heart Association Acute Cardiac Care Committee of the Council on Clinical Cardiology. Circulation. 2008 Apr 8;117(14):1897-907. doi: 10.1161/CIRCULATIONAHA.107.188950. Epub 2008 Mar 17. No abstract available.

    PubMed 18347214

  • Phillips K, Luk A, Soor GS, Abraham JR, Leong S, Butany J. Cocaine cardiotoxicity: a review of the pathophysiology, pathology, and treatment options. Am J Cardiovasc Drugs. 2009;9(3):177-96. doi: 10.2165/00129784-200909030-00005.

    PubMed 19463023

  • Steinhauer JR, Caulfield JB. Spontaneous coronary artery dissection associated with cocaine use: a case report and brief review. Cardiovasc Pathol. 2001 May-Jun;10(3):141-5. doi: 10.1016/s1054-8807(01)00074-6.

    PubMed 11485859

  • Sanchez T, Finlayson T, Drake A, Behel S, Cribbin M, Dinenno E, Hall T, Kramer S, Lansky A; Centers for Disease Control and Prevention (CDC). Human immunodeficiency virus (HIV) risk, prevention, and testing behaviors--United States, National HIV Behavioral Surveillance System: men who have sex with men, November 2003-April 2005. MMWR Surveill Summ. 2006 Jul 7;55(6):1-16.

    PubMed 16826162

  • Raymond HF, Chen YH, Ick T, Scheer S, Bernstein K, Liska S, Louie B, Pandori M, McFarland W. A new trend in the HIV epidemic among men who have sex with men, San Francisco, 2004-2011. J Acquir Immune Defic Syndr. 2013 Apr 15;62(5):584-9. doi: 10.1097/QAI.0b013e318285febf.

    PubMed 23334505

  • Mimiaga MJ, Reisner SL, Fontaine YM, Bland SE, Driscoll MA, Isenberg D, Cranston K, Skeer MR, Mayer KH. Walking the line: stimulant use during sex and HIV risk behavior among Black urban MSM. Drug Alcohol Depend. 2010 Jul 1;110(1-2):30-7. doi: 10.1016/j.drugalcdep.2010.01.017. Epub 2010 Mar 23.

    PubMed 20334986

  • Colfax G, Vittinghoff E, Husnik MJ, McKirnan D, Buchbinder S, Koblin B, Celum C, Chesney M, Huang Y, Mayer K, Bozeman S, Judson FN, Bryant KJ, Coates TJ; EXPLORE Study Team. Substance use and sexual risk: a participant- and episode-level analysis among a cohort of men who have sex with men. Am J Epidemiol. 2004 May 15;159(10):1002-12. doi: 10.1093/aje/kwh135.

    PubMed 15128613

  • Ober A, Shoptaw S, Wang PC, Gorbach P, Weiss RE. Factors associated with event-level stimulant use during sex in a sample of older, low-income men who have sex with men in Los Angeles. Drug Alcohol Depend. 2009 Jun 1;102(1-3):123-9. doi: 10.1016/j.drugalcdep.2009.02.002. Epub 2009 Mar 26.

    PubMed 19327917

  • Mackesy-Amiti ME, Fendrich M, Johnson TP. Symptoms of substance dependence and risky sexual behavior in a probability sample of HIV-negative men who have sex with men in Chicago. Drug Alcohol Depend. 2010 Jul 1;110(1-2):38-43. doi: 10.1016/j.drugalcdep.2010.01.016. Epub 2010 Mar 9.

    PubMed 20219291

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing lorcaserin, Substance use counseling and ACASI in people with Cocaine Use Disorder, run by Glenn-Milo Santos at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Percentage of Weekly Follow-up Visits of Randomized Study Participants (time frame: 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03192995, which also lists 73 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023; AzTrials last refreshed its copy on 1 Nov 2026.

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