Treatment With Lorcaserin for Cocaine Use: The TLC Study

Cocaine Use Disorder Clinical Trial

— TLC  

Official title:

Treatment With Lorcaserin for Cocaine Use: The TLC Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03192995
• Other study ID #: 17-21502
• Secondary ID: 1R34DA042161
• Status: Terminated
• Phase: Phase 2
• Start date: January 1, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: August 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 treatment (lorcaserin) arm or the placebo arm, to be taken twice a day for 12 weeks.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: June 30, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cocaine Use Disorder

Intervention

Drug:
• lorcaserin
lorcaserin 20 mg tablet
• Placebo Oral Tablet
placebo 20 mg. tablet

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	San Francisco Department of Public Health	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Glenn-Milo Santos	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (73)

Alex KD, Pehek EA. Pharmacologic mechanisms of serotonergic regulation of dopamine neurotransmission. Pharmacol Ther. 2007 Feb;113(2):296-320. doi: 10.1016/j.pharmthera.2006.08.004. Epub 2006 Oct 17. — View Citation

Batki SL, Washburn AM, Delucchi K, Jones RT. A controlled trial of fluoxetine in crack cocaine dependence. Drug Alcohol Depend. 1996 Jun;41(2):137-42. doi: 10.1016/0376-8716(96)01233-1. — View Citation

Bohula EA, Wiviott SD, McGuire DK, Inzucchi SE, Kuder J, Im K, Fanola CL, Qamar A, Brown C, Budaj A, Garcia-Castillo A, Gupta M, Leiter LA, Weissman NJ, White HD, Patel T, Francis B, Miao W, Perdomo C, Dhadda S, Bonaca MP, Ruff CT, Keech AC, Smith SR, Sabatine MS, Scirica BM; CAMELLIA-TIMI 61 Steering Committee and Investigators. Cardiovascular Safety of Lorcaserin in Overweight or Obese Patients. N Engl J Med. 2018 Sep 20;379(12):1107-1117. doi: 10.1056/NEJMoa1808721. Epub 2018 Aug 26. — View Citation

Bowers JR, Branson CM, Fletcher JB, Reback CJ. Predictors of HIV Sexual Risk Behavior among Men Who Have Sex with Men, Men Who Have Sex with Men and Women, and Transgender Women. Int J Sex Health. 2012;24(4):290-302. doi: 10.1080/19317611.2012.715120. — View Citation

Bubar MJ, Cunningham KA. Prospects for serotonin 5-HT2R pharmacotherapy in psychostimulant abuse. Prog Brain Res. 2008;172:319-46. doi: 10.1016/S0079-6123(08)00916-3. — View Citation

Bubar MJ, Cunningham KA. Serotonin 5-HT2A and 5-HT2C receptors as potential targets for modulation of psychostimulant use and dependence. Curr Top Med Chem. 2006;6(18):1971-85. doi: 10.2174/156802606778522131. — View Citation

Burton CL, Rizos Z, Diwan M, Nobrega JN, Fletcher PJ. Antagonizing 5-HT(2)A receptors with M100907 and stimulating 5-HT(2)C receptors with Ro60-0175 blocks cocaine-induced locomotion and zif268 mRNA expression in Sprague-Dawley rats. Behav Brain Res. 2013 Mar 1;240:171-81. doi: 10.1016/j.bbr.2012.11.030. Epub 2012 Nov 28. — View Citation

Carrico AW. Substance use and HIV disease progression in the HAART era: implications for the primary prevention of HIV. Life Sci. 2011 May 23;88(21-22):940-7. doi: 10.1016/j.lfs.2010.10.002. Epub 2010 Oct 8. — View Citation

Centers for Disease Control and Prevention. Revised guidelines for HIV counseling, testing, and referral. MMWR Recomm Rep. 2001 Nov 9;50(RR-19):1-57; quiz CE1-19a1-CE6-19a1. — View Citation

Cepeda JA, Vickerman P, Bruneau J, Zang G, Borquez A, Farrell M, Degenhardt L, Martin NK. Estimating the contribution of stimulant injection to HIV and HCV epidemics among people who inject drugs and implications for harm reduction: A modeling analysis. Drug Alcohol Depend. 2020 Aug 1;213:108135. doi: 10.1016/j.drugalcdep.2020.108135. Epub 2020 Jun 24. — View Citation

Chan B, Kondo K, Freeman M, Ayers C, Montgomery J, Kansagara D. Pharmacotherapy for Cocaine Use Disorder-a Systematic Review and Meta-analysis. J Gen Intern Med. 2019 Dec;34(12):2858-2873. doi: 10.1007/s11606-019-05074-8. Epub 2019 Jun 10. — View Citation

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. — View Citation

Colfax GN, Santos GM, Das M, Santos DM, Matheson T, Gasper J, Shoptaw S, Vittinghoff E. Mirtazapine to reduce methamphetamine use: a randomized controlled trial. Arch Gen Psychiatry. 2011 Nov;68(11):1168-75. doi: 10.1001/archgenpsychiatry.2011.124. — View Citation

Cook JA, Burke-Miller JK, Cohen MH, Cook RL, Vlahov D, Wilson TE, Golub ET, Schwartz RM, Howard AA, Ponath C, Plankey MW, Levine AM, Grey DD. Crack cocaine, disease progression, and mortality in a multicenter cohort of HIV-1 positive women. AIDS. 2008 Jul 11;22(11):1355-63. doi: 10.1097/QAD.0b013e32830507f2. Erratum In: AIDS. 2008 Sep 12;22(14):i. Levine, Andrea [corrected to Levine, Alexandra M]. — View Citation

Craige CP, Unterwald EM. Serotonin (2C) receptor regulation of cocaine-induced conditioned place preference and locomotor sensitization. Behav Brain Res. 2013 Feb 1;238:206-10. doi: 10.1016/j.bbr.2012.10.034. Epub 2012 Oct 26. — View Citation

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/ — View Citation

Cunningham KA, Fox RG, Anastasio NC, Bubar MJ, Stutz SJ, Moeller FG, Gilbertson SR, Rosenzweig-Lipson S. Selective serotonin 5-HT(2C) receptor activation suppresses the reinforcing efficacy of cocaine and sucrose but differentially affects the incentive-salience value of cocaine- vs. sucrose-associated cues. Neuropharmacology. 2011 Sep;61(3):513-23. doi: 10.1016/j.neuropharm.2011.04.034. Epub 2011 May 11. — View Citation

Das M, Santos D, Matheson T, Santos GM, Chu P, Vittinghoff E, Shoptaw S, Colfax GN. Feasibility and acceptability of a phase II randomized pharmacologic intervention for methamphetamine dependence in high-risk men who have sex with men. AIDS. 2010 Apr 24;24(7):991-1000. doi: 10.1097/qad.0b013e328336e98b. — View Citation

Day SJ, Altman DG. Statistics notes: blinding in clinical trials and other studies. BMJ. 2000 Aug 19-26;321(7259):504. doi: 10.1136/bmj.321.7259.504. No abstract available. — View Citation

de Andrade Mesquita L, Fagundes Piccoli G, Richter da Natividade G, Frison Spiazzi B, Colpani V, Gerchman F. Is lorcaserin really associated with increased risk of cancer? A systematic review and meta-analysis. Obes Rev. 2021 Mar;22(3):e13170. doi: 10.1111/obr.13170. Epub 2020 Dec 1. — View Citation

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. — View Citation

Delucchi KL, Jones RT, Batki SL. Measurement properties of quantitative urine benzoylecgonine in clinical trials research. Addiction. 1997 Mar;92(3):297-302. — View Citation

Dunn C, Deroo L, Rivara FP. The use of brief interventions adapted from motivational interviewing across behavioral domains: a systematic review. Addiction. 2001 Dec;96(12):1725-42. doi: 10.1046/j.1360-0443.2001.961217253.x. — View Citation

Filip M, Alenina N, Bader M, Przegalinski E. Behavioral evidence for the significance of serotoninergic (5-HT) receptors in cocaine addiction. Addict Biol. 2010 Jul;15(3):227-49. doi: 10.1111/j.1369-1600.2010.00214.x. Epub 2010 Apr 29. — View Citation

Filip M, Spampinato U, McCreary AC, Przegalinski E. Pharmacological and genetic interventions in serotonin (5-HT)(2C) receptors to alter drug abuse and dependence processes. Brain Res. 2012 Oct 2;1476:132-53. doi: 10.1016/j.brainres.2012.03.035. Epub 2012 Mar 23. — View Citation

Fletcher PJ, Rizos Z, Noble K, Higgins GA. Impulsive action induced by amphetamine, cocaine and MK801 is reduced by 5-HT(2C) receptor stimulation and 5-HT(2A) receptor blockade. Neuropharmacology. 2011 Sep;61(3):468-77. doi: 10.1016/j.neuropharm.2011.02.025. Epub 2011 Mar 21. — View Citation

Gonzalez-Saiz F, Domingo-Salvany A, Barrio G, Sanchez-Niubo A, Brugal MT, de la Fuente L, Alonso J. Severity of dependence scale as a diagnostic tool for heroin and cocaine dependence. Eur Addict Res. 2009;15(2):87-93. doi: 10.1159/000189787. Epub 2009 Jan 10. — View Citation

Grottick AJ, Fletcher PJ, Higgins GA. Studies to investigate the role of 5-HT(2C) receptors on cocaine- and food-maintained behavior. J Pharmacol Exp Ther. 2000 Dec;295(3):1183-91. — View Citation

Haberer JE, Kahane J, Kigozi I, Emenyonu N, Hunt P, Martin J, Bangsberg DR. Real-time adherence monitoring for HIV antiretroviral therapy. AIDS Behav. 2010 Dec;14(6):1340-6. doi: 10.1007/s10461-010-9799-4. — View Citation

Higgins GA, Fletcher PJ, Shanahan WR. Lorcaserin: A review of its preclinical and clinical pharmacology and therapeutic potential. Pharmacol Ther. 2020 Jan;205:107417. doi: 10.1016/j.pharmthera.2019.107417. Epub 2019 Oct 16. — View Citation

Higgins GA, Sellers EM, Fletcher PJ. From obesity to substance abuse: therapeutic opportunities for 5-HT2C receptor agonists. Trends Pharmacol Sci. 2013 Oct;34(10):560-70. doi: 10.1016/j.tips.2013.08.001. Epub 2013 Sep 13. — View Citation

Higgins GA, Silenieks LB, Rossmann A, Rizos Z, Noble K, Soko AD, Fletcher PJ. The 5-HT2C receptor agonist lorcaserin reduces nicotine self-administration, discrimination, and reinstatement: relationship to feeding behavior and impulse control. Neuropsychopharmacology. 2012 Apr;37(5):1177-91. doi: 10.1038/npp.2011.303. Epub 2011 Dec 21. — View Citation

Hinkin CH, Barclay TR, Castellon SA, Levine AJ, Durvasula RS, Marion SD, Myers HF, Longshore D. Drug use and medication adherence among HIV-1 infected individuals. AIDS Behav. 2007 Mar;11(2):185-94. doi: 10.1007/s10461-006-9152-0. — View Citation

Hunt MK, Hopko DR, Bare R, Lejuez CW, Robinson EV. Construct validity of the Balloon Analog Risk Task (BART): associations with psychopathy and impulsivity. Assessment. 2005 Dec;12(4):416-28. doi: 10.1177/1073191105278740. — View Citation

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. — View Citation

Katsidoni V, Apazoglou K, Panagis G. Role of serotonin 5-HT2A and 5-HT2C receptors on brain stimulation reward and the reward-facilitating effect of cocaine. Psychopharmacology (Berl). 2011 Feb;213(2-3):337-54. doi: 10.1007/s00213-010-1887-7. Epub 2010 Jun 25. — View Citation

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. — View Citation

Koblin B, Chesney M, Coates T; EXPLORE Study Team. Effects of a behavioural intervention to reduce acquisition of HIV infection among men who have sex with men: the EXPLORE randomised controlled study. Lancet. 2004 Jul 3-9;364(9428):41-50. doi: 10.1016/S0140-6736(04)16588-4. — View Citation

Koblin BA, Husnik MJ, Colfax G, Huang Y, Madison M, Mayer K, Barresi PJ, Coates TJ, Chesney MA, Buchbinder S. Risk factors for HIV infection among men who have sex with men. AIDS. 2006 Mar 21;20(5):731-9. doi: 10.1097/01.aids.0000216374.61442.55. — View Citation

Lambert G, Cox J, Hottes TS, Tremblay C, Frigault LR, Alary M, Otis J, Remis RS; M-Track Study Group. Correlates of unprotected anal sex at last sexual episode: analysis from a surveillance study of men who have sex with men in Montreal. AIDS Behav. 2011 Apr;15(3):584-95. doi: 10.1007/s10461-009-9605-3. — View Citation

Lash TL, Ahern TP. Bias analysis to guide new data collection. Int J Biostat. 2012 Jan 6;8(2):/j/ijb.2012.8.issue-2/1557-4679.1345/1557-4679.1345.xml. doi: 10.2202/1557-4679.1345. — View Citation

Leggio GM, Cathala A, Moison D, Cunningham KA, Piazza PV, Spampinato U. Serotonin2C receptors in the medial prefrontal cortex facilitate cocaine-induced dopamine release in the rat nucleus accumbens. Neuropharmacology. 2009 Feb;56(2):507-13. doi: 10.1016/j.neuropharm.2008.10.005. Epub 2008 Oct 17. — View Citation

Li SH, Chiang CN, Tai BC, Marschke CK, Hawks RL. Quantitative versus qualitative urinalysis for benzoylecgonine in clinical trials for the assessment of cocaine use. Psychopharmacol Bull. 1995;31(4):671-9. — View Citation

Macalino GE, Celentano DD, Latkin C, Strathdee SA, Vlahov D. Risk behaviors by audio computer-assisted self-interviews among HIV-seropositive and HIV-seronegative injection drug users. AIDS Educ Prev. 2002 Oct;14(5):367-78. doi: 10.1521/aeap.14.6.367.24075. — View Citation

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. — View Citation

Manvich DF, Kimmel HL, Howell LL. Effects of serotonin 2C receptor agonists on the behavioral and neurochemical effects of cocaine in squirrel monkeys. J Pharmacol Exp Ther. 2012 May;341(2):424-34. doi: 10.1124/jpet.111.186981. Epub 2012 Feb 10. — View Citation

McCann DJ, Li SH. A novel, nonbinary evaluation of success and failure reveals bupropion efficacy versus methamphetamine dependence: reanalysis of a multisite trial. CNS Neurosci Ther. 2012 May;18(5):414-8. doi: 10.1111/j.1755-5949.2011.00263.x. Epub 2011 Oct 18. — View Citation

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. — View Citation

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. — View Citation

Negus SS, Banks ML. Learning from lorcaserin: lessons from the negative clinical trial of lorcaserin to treat cocaine use disorder. Neuropsychopharmacology. 2020 Nov;45(12):1967-1973. doi: 10.1038/s41386-020-00815-4. Epub 2020 Aug 24. No abstract available. — View Citation

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. — View Citation

Ostrow DG, DiFranceisco WJ, Chmiel JS, Wagstaff DA, Wesch J. A case-control study of human immunodeficiency virus type 1 seroconversion and risk-related behaviors in the Chicago MACS/CCS Cohort, 1984-1992. Multicenter AIDS Cohort Study. Coping and Change Study. Am J Epidemiol. 1995 Oct 15;142(8):875-83. doi: 10.1093/oxfordjournals.aje.a117727. Erratum In: Am J Epidemiol 1996 Jan 1;143(1):104. — View Citation

Ostrow DG, Plankey MW, Cox C, Li X, Shoptaw S, Jacobson LP, Stall RC. Specific sex drug combinations contribute to the majority of recent HIV seroconversions among MSM in the MACS. J Acquir Immune Defic Syndr. 2009 Jul 1;51(3):349-55. doi: 10.1097/QAI.0b013e3181a24b20. — View Citation

Palacios JM, Pazos A, Hoyer D. A short history of the 5-HT2C receptor: from the choroid plexus to depression, obesity and addiction treatment. Psychopharmacology (Berl). 2017 May;234(9-10):1395-1418. doi: 10.1007/s00213-017-4545-5. Epub 2017 Mar 7. — View Citation

Pelloux Y, Dilleen R, Economidou D, Theobald D, Everitt BJ. Reduced forebrain serotonin transmission is causally involved in the development of compulsive cocaine seeking in rats. Neuropsychopharmacology. 2012 Oct;37(11):2505-14. doi: 10.1038/npp.2012.111. Epub 2012 Jul 4. — View Citation

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. — View Citation

Pirtle JL, Hickman MD, Boinpelly VC, Surineni K, Thakur HK, Grasing KW. The serotonin-2C agonist Lorcaserin delays intravenous choice and modifies the subjective and cardiovascular effects of cocaine: A randomized, controlled human laboratory study. Pharmacol Biochem Behav. 2019 May;180:52-59. doi: 10.1016/j.pbb.2019.02.010. Epub 2019 Feb 24. — View Citation

Pockros LA, Pentkowski NS, Conway SM, Ullman TE, Zwick KR, Neisewander JL. 5-HT(2A) receptor blockade and 5-HT(2C) receptor activation interact to reduce cocaine hyperlocomotion and Fos protein expression in the caudate-putamen. Synapse. 2012 Dec;66(12):989-1001. doi: 10.1002/syn.21592. Epub 2012 Sep 11. — View Citation

Preston KL, Epstein DH, Cone EJ, Wtsadik AT, Huestis MA, Moolchan ET. Urinary elimination of cocaine metabolites in chronic cocaine users during cessation. J Anal Toxicol. 2002 Oct;26(7):393-400. doi: 10.1093/jat/26.7.393. — View Citation

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. — View Citation

Reise SP, Moore TM, Sabb FW, Brown AK, London ED. The Barratt Impulsiveness Scale-11: reassessment of its structure in a community sample. Psychol Assess. 2013 Jun;25(2):631-42. doi: 10.1037/a0032161. Epub 2013 Apr 1. — View Citation

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. — View Citation

Rothman RB, Blough BE, Baumann MH. Dopamine/serotonin releasers as medications for stimulant addictions. Prog Brain Res. 2008;172:385-406. doi: 10.1016/S0079-6123(08)00919-9. — View Citation

Samet JH, Rollnick S, Barnes H. Beyond CAGE. A brief clinical approach after detection of substance abuse. Arch Intern Med. 1996 Nov 11;156(20):2287-93. doi: 10.1001/archinte.156.20.2287. — View Citation

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. Erratum In: MMWR Morb Mortal Wkly Rep. 2006 Jul 14;55(27):752. — View Citation

Santos GM, Coffin PO, Das M, Matheson T, DeMicco E, Raiford JL, Vittinghoff E, Dilley JW, Colfax G, Herbst JH. Dose-response associations between number and frequency of substance use and high-risk sexual behaviors among HIV-negative substance-using men who have sex with men (SUMSM) in San Francisco. J Acquir Immune Defic Syndr. 2013 Aug 1;63(4):540-4. doi: 10.1097/QAI.0b013e318293f10b. — View Citation

Santos GM, Ikeda J, Coffin P, Walker JE, Matheson T, McLaughlin M, Jain J, Vittinghoff E, Batki SL. Pilot study of extended-release lorcaserin for cocaine use disorder among men who have sex with men: A double-blind, placebo-controlled randomized trial. P — View Citation

Shoptaw S, Stall R, Bordon J, Kao U, Cox C, Li X, Ostrow DG, Plankey MW. Cumulative exposure to stimulants and immune function outcomes among HIV-positive and HIV-negative men in the Multicenter AIDS Cohort Study. Int J STD AIDS. 2012 Aug;23(8):576-80. doi: 10.1258/ijsa.2012.011322. — View Citation

Sobell LC, Brown J, Leo GI, Sobell MB. The reliability of the Alcohol Timeline Followback when administered by telephone and by computer. Drug Alcohol Depend. 1996 Sep;42(1):49-54. doi: 10.1016/0376-8716(96)01263-x. — View Citation

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. — View Citation

Tyndall MW, Currie S, Spittal P, Li K, Wood E, O'Shaughnessy MV, Schechter MT. Intensive injection cocaine use as the primary risk factor in the Vancouver HIV-1 epidemic. AIDS. 2003 Apr 11;17(6):887-93. doi: 10.1097/00002030-200304110-00014. — View Citation

Tziortzis D, Mahoney JJ 3rd, Kalechstein AD, Newton TF, De La Garza R 2nd. The relationship between impulsivity and craving in cocaine- and methamphetamine-dependent volunteers. Pharmacol Biochem Behav. 2011 Apr;98(2):196-202. doi: 10.1016/j.pbb.2010.12.022. Epub 2011 Jan 6. — View Citation

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. — View Citation

* Note: There are 73 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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