CLINICAL TRIALS PROFILE FOR LUCEMYRA
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All Clinical Trials for LUCEMYRA
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT03718065 ↗ | Impact of Lofexidine on Stress, Craving and Opioid Use | Recruiting | National Institute on Drug Abuse (NIDA) | Phase 2 | 2019-06-26 | Individuals with opioid use disorder who are stabilized on buprenorphine or methadone will be randomly assigned to receive placebo or lofexidine for 5 weeks. At the end of five weeks, they will complete a human laboratory stress task and scripted opioid imagery task. Throughout the study a CREMA app (Cue Reactivity Ecological Momentary Assessment) will be used to monitor stress, craving and use in the natural environment. |
| NCT03718065 ↗ | Impact of Lofexidine on Stress, Craving and Opioid Use | Recruiting | National Institutes of Health (NIH) | Phase 2 | 2019-06-26 | Individuals with opioid use disorder who are stabilized on buprenorphine or methadone will be randomly assigned to receive placebo or lofexidine for 5 weeks. At the end of five weeks, they will complete a human laboratory stress task and scripted opioid imagery task. Throughout the study a CREMA app (Cue Reactivity Ecological Momentary Assessment) will be used to monitor stress, craving and use in the natural environment. |
| NCT03718065 ↗ | Impact of Lofexidine on Stress, Craving and Opioid Use | Recruiting | Medical University of South Carolina | Phase 2 | 2019-06-26 | Individuals with opioid use disorder who are stabilized on buprenorphine or methadone will be randomly assigned to receive placebo or lofexidine for 5 weeks. At the end of five weeks, they will complete a human laboratory stress task and scripted opioid imagery task. Throughout the study a CREMA app (Cue Reactivity Ecological Momentary Assessment) will be used to monitor stress, craving and use in the natural environment. |
| NCT04056182 ↗ | Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment | Completed | US WorldMeds LLC | Phase 2 | 2019-09-01 | This is an open-label pilot trial to evaluate the safety and tolerability of lofexidine in the management of opioid withdrawal symptoms while initiating outpatient treatment with naltrexone. The initiation procedure will be a flexible detoxification lasting 2 to 10 days concluding with the injection of XR-Naltrexone (Vivitrol). Vivitrol is a long-acting injection that contains enough medicine to last for one month blocking the effects of opioids. |
| NCT04056182 ↗ | Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment | Completed | Frances R Levin | Phase 2 | 2019-09-01 | This is an open-label pilot trial to evaluate the safety and tolerability of lofexidine in the management of opioid withdrawal symptoms while initiating outpatient treatment with naltrexone. The initiation procedure will be a flexible detoxification lasting 2 to 10 days concluding with the injection of XR-Naltrexone (Vivitrol). Vivitrol is a long-acting injection that contains enough medicine to last for one month blocking the effects of opioids. |
| NCT04070157 ↗ | Randomized, Double-Blind, Placebo-Controlled Pilot Study on the Safety and Effectiveness of LUCEMYRA During an Opioid Taper in Treatment of Withdrawal | Suspended | US WorldMeds LLC | Phase 2 | 2019-08-02 | Stopping prescription opioid pain medications can be difficult due to withdrawal symptoms. This study will test if LUCEMYRA helps reduce withdrawal symptoms and helps more people reduce their opioid dose compared to placebo. |
| NCT04188730 ↗ | A Study Evaluating the Relative Bioavailability of Lofexidine Granules for Reconstitution Compared to LUCEMYRA (Lofexidine) Tablets and the Effect of Food on the Bioavailability of the Lofexidine Granules for Reconstitution | Completed | National Institute on Drug Abuse (NIDA) | Phase 1 | 2021-02-16 | The purpose of this open-label, single-dose, randomized, three-treatment, three-period, four-sequence, crossover study is to evaluate the relative bioavailability of a test formulation of lofexidine granules for reconstitution (oral) and LUCEMYRA tablets under fasted conditions and to evaluate the effect of food on the relative bioavailability of lofexidine granules for reconstitution (oral) when administered under fed compared to fasted conditions. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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