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Randomized Controlled Trial
. 2021 Feb 1:219:108482.
doi: 10.1016/j.drugalcdep.2020.108482. Epub 2021 Jan 5.

Lorcaserin treatment for extended-release naltrexone induction and retention for opioid use disorder individuals: A pilot, placebo-controlled randomized trial

Frances R Levin  1 , John J Mariani  2 , Martina Pavlicova  3 , C Jean Choi  4 , Cale Basaraba  4 , Amy L Mahony  5 , Daniel J Brooks  5 , Nasir Naqvi  2 , Adam Bisaga  2
Affiliations
Randomized Controlled Trial

Lorcaserin treatment for extended-release naltrexone induction and retention for opioid use disorder individuals: A pilot, placebo-controlled randomized trial

Frances R Levin et al. Drug Alcohol Depend. .

Abstract

Background: Opioid Use Disorder (OUD) is a significant public health problem associated with severe morbidity and mortality. While effective pharmacotherapies are available, limitations exist with each. Induction onto extended-release naltrexone (XR-NTX) is more difficult than initiation of buprenorphine or methadone, even in inpatient settings, as it is recommended that patients remain abstinent for at least 7 days prior to initiating XR-NTX. The purpose of this trial was to determine if lorcaserin, a 5HT2c agonist, improves outpatient XR-NTX induction rates.

Methods: An 8-week trial beginning with a brief detoxification period and induction onto XR-NTX. Sixty participants with OUD were enrolled in the trial, with 49 participants at the initiation of detoxification randomized to lorcaserin or placebo for 39 days. Additionally, ancillary medications were provided. The primary outcome was the proportion of participants inducted onto the first XR-NTX injection. Secondary outcomes were withdrawal severity (measured by COWS and SOWS) prior to the first injection and the proportion of participants receiving the second XR-NTX injection.

Results: The proportion of participants inducted onto the first (lorcaserin: 36 %; placebo: 44 %; p = .67) and the second XR-NTX injection (lorcaserin: 27 %; placebo: 31 %; p = .77) was not significantly different between treatment arms. Prior to the first injection, withdrawal scores did not significantly differ between treatment arms over time (treatment*time interaction COWS: p = .11; SOWS: p = .39).

Conclusions: Lorcaserin failed to improve outpatient XR-NTX induction rates. Although this study is small, the findings do not support the use of lorcaserin in promoting induction onto XR-NTX or in mitigating withdrawal symptoms.

Keywords: Clinical trial; Extended-release naltrexone; Induction; Lorcaserin; Opioid use disorder; Treatment.

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Conflict of interest statement

Conflict of Interest

Drs. Mariani, Pavlicova, and Naqvi reported no biomedical financial interests or potential conflicts of interest. Also, Ms. Choi, Mr. Brooks, Mr. Basaraba and Ms. Mahony reported no biomedical financial interests or potential conflicts of interest. Dr. Levin has acted as an unpaid consultant for Alkermes, Novartis, and US WorldMeds. She receives research support from US WorldMeds. Dr. Bisaga has received research support from Alkermes.

Figures

Figure 1.
Figure 1.
CONSORT Diagram.
Figure 2.
Figure 2.
(A) Proportion of all participants who received 1st injection by study arm (B) Proportion of heroin or opioid pill users (with fentanyl status) who received the 1st injection by study arm.
Figure 3.
Figure 3.
Model-estimated (adjusted by baseline withdrawal, age, opioid type, and severity of use) means and 95% confidence intervals of withdrawal for (A) COWS and (B) SOWS, before first injection.
See this image and copyright information in PMC

References

    1. American Psychiatric Association (APA), 2013. Diagnostic and Statistical Manual of Mental Disorders 5th Edition Arlington, VA, American Psychiatric Association.
    1. Bisaga A, Sullivan MA, Glass A, Mishlen K, Carpenter KM, Mariani JJ, Levin FR, Nunes EV, 2014. A placebo-controlled trial of memantine as an adjunct to injectable extended-release naltrexone for opioid dependence. J. Subst. Abuse Treat 46, 546–552. - PMC - PubMed
    1. Bisaga A, Sullivan MA, Glass A, Mishlen K, Pavlicova M, Haney M, Raby WN, Levin FR, Carpenter KM, Mariani JJ, Nunes EV, 2015. The effects of dronabinol during detoxification and the initiation of treatment with extended release naltrexone. Drug Alcohol Depend 154, 38–45. - PMC - PubMed
    1. Bisaga A, Mannelli P, Yu M, Nangia N, Graham CE, Tompkins DA, Kosten TR, Akerman SC, Silverman BL, Sullivan MA, 2018. Outpatient transition to extended-release injectable naltrexone for patients with opioid use disorder: A phase 3 randomized trial. Drug Alcohol Depend 187, 171–178. - PubMed
    1. Brandt L, Jones JD, Martinez S, Manubay JM, Mogali S, Ramey T, Levin FR, Comer SD, 2020. Effects of lorcaserin on oxycodone self-administration and subjective responses in participants with opioid use disorder. Drug Alcohol Depend 208, 107859 10.1016/j.drugalcdep.2020.107859 - DOI - PMC - PubMed

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