TY - JOUR
KW - Adult
KW - Amphetamine-Related Disorders
KW - Benzazepines
KW - Double-Blind Method
KW - Homosexuality, Male
KW - Humans
KW - Male
KW - Middle Aged
KW - Pilot Projects
AU - G. M. Santos
AU - J. Ikeda
AU - P. Coffin
AU - J. E. Walker
AU - T. Matheson
AU - M. McLaughlin
AU - J. Jain
AU - E. Vittinghoff
AU - S. L. Batki
A1 - 
AB - OBJECTIVE: To determine if men who have sex with men (MSM) with cocaine use disorder (CUD) and actively-using cocaine could be enrolled and retained in a pharmacologic intervention trial of lorcaserin-a novel 5-HT2cR agonist-and determine the degree to which participants would adhere to study procedures. METHODS: This was a phase II randomized, double-blind, placebo-controlled pilot study with 2:1 random parallel group assignment to daily extended-release oral lorcaserin 20 mg versus placebo (clinicaltrials.gov identifier-NCT03192995). Twenty-two of a planned 45 cisgender MSM with CUD were enrolled and had weekly follow-up visits during a 12-week treatment period, with substance use counseling, urine specimen collection, and completion of audio-computer assisted self-interview (ACASI) behavioral risk assessments. Adherence was measured by medication event monitoring systems (MEMS) caps and self-report. This study was terminated early because of an FDA safety alert for lorcaserin's long-term use. RESULTS: Eighty-six percent completed the trial, with 82% of weekly study follow-up visits completed. Adherence was 55.3% (lorcaserin 51.6% vs. placebo 66.2%) by MEMS cap and 56.9% (56.5% vs. placebo 57.9%) by self-report and did not differ significantly by treatment assignment. Intention-to-treat analyses (ITT) did not show differences in cocaine positivity by urine screen between the lorcaserin and placebo groups by 12 week follow-up (incidence risk ratio [IRR]: 0.96; 95%CI = 0.24-3.82, P = 0.95). However, self-reported cocaine use in timeline follow-back declined more significantly in the lorcaserin group compared to placebo (IRR: 0.66; 95%CI = 0.49-0.88; P = 0.004). CONCLUSION: We found that it is feasible, acceptable, and tolerable to conduct a placebo-controlled pharmacologic trial for MSM with CUD who are actively using cocaine. Lorcaserin was not associated with significant reductions in cocaine use by urine testing, but was associated with significant reductions in self-reported cocaine use. Future research may be needed to continue to explore the potential utility of 5-HT2cR agonists.
AD - Department of Community Health Systems, University of California, San Francisco, CA, United States of America.; Center on Substance Use and Health, San Francisco Department of Public Health, San Francisco, CA, United States of America.; Center on Substance Use and Health, San Francisco Department of Public Health, San Francisco, CA, United States of America.; Center on Substance Use and Health, San Francisco Department of Public Health, San Francisco, CA, United States of America.; Division of HIV, Infectious Disease & Global Medicine, University of California, San Francisco, CA, United States of America.; Center on Substance Use and Health, San Francisco Department of Public Health, San Francisco, CA, United States of America.; Center on Substance Use and Health, San Francisco Department of Public Health, San Francisco, CA, United States of America.; Center on Substance Use and Health, San Francisco Department of Public Health, San Francisco, CA, United States of America.; Department of Psychiatry and Behavioral Sciences, University of California, San Francisco, CA, United States of America.; Department of Epidemiology and Biostatistics, University of California, San Francisco, CA, United States of America.; Department of Psychiatry and Behavioral Sciences, University of California, San Francisco, CA, United States of America.; San Francisco VA Health Care System (SFVAHCS), San Francisco, CA, United States of America.
BT - PloS one
C5 - Healthcare Disparities; Opioids & Substance Use
CP - 7
DO - 10.1371/journal.pone.0254724
IS - 7
JF - PloS one
LA - eng
M1 - Journal Article
N2 - OBJECTIVE: To determine if men who have sex with men (MSM) with cocaine use disorder (CUD) and actively-using cocaine could be enrolled and retained in a pharmacologic intervention trial of lorcaserin-a novel 5-HT2cR agonist-and determine the degree to which participants would adhere to study procedures. METHODS: This was a phase II randomized, double-blind, placebo-controlled pilot study with 2:1 random parallel group assignment to daily extended-release oral lorcaserin 20 mg versus placebo (clinicaltrials.gov identifier-NCT03192995). Twenty-two of a planned 45 cisgender MSM with CUD were enrolled and had weekly follow-up visits during a 12-week treatment period, with substance use counseling, urine specimen collection, and completion of audio-computer assisted self-interview (ACASI) behavioral risk assessments. Adherence was measured by medication event monitoring systems (MEMS) caps and self-report. This study was terminated early because of an FDA safety alert for lorcaserin's long-term use. RESULTS: Eighty-six percent completed the trial, with 82% of weekly study follow-up visits completed. Adherence was 55.3% (lorcaserin 51.6% vs. placebo 66.2%) by MEMS cap and 56.9% (56.5% vs. placebo 57.9%) by self-report and did not differ significantly by treatment assignment. Intention-to-treat analyses (ITT) did not show differences in cocaine positivity by urine screen between the lorcaserin and placebo groups by 12 week follow-up (incidence risk ratio [IRR]: 0.96; 95%CI = 0.24-3.82, P = 0.95). However, self-reported cocaine use in timeline follow-back declined more significantly in the lorcaserin group compared to placebo (IRR: 0.66; 95%CI = 0.49-0.88; P = 0.004). CONCLUSION: We found that it is feasible, acceptable, and tolerable to conduct a placebo-controlled pharmacologic trial for MSM with CUD who are actively using cocaine. Lorcaserin was not associated with significant reductions in cocaine use by urine testing, but was associated with significant reductions in self-reported cocaine use. Future research may be needed to continue to explore the potential utility of 5-HT2cR agonists.
PY - 2021
SN - 1932-6203; 1932-6203
T1 - Pilot study of extended-release lorcaserin for cocaine use disorder among men who have sex with men: A double-blind, placebo-controlled randomized trial
T2 - PloS one
TI - Pilot study of extended-release lorcaserin for cocaine use disorder among men who have sex with men: A double-blind, placebo-controlled randomized trial
U1 - Healthcare Disparities; Opioids & Substance Use
U2 - 34265007
U3 - 10.1371/journal.pone.0254724
VL - 16
VO - 1932-6203; 1932-6203
Y1 - 2021
Y2 - Jul 15
ER -