Trial Outcomes & Findings for Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment (NCT NCT04056182)

NCT ID: NCT04056182

Last Updated: 2021-12-09

Results Overview

number of participants inducted onto Vivitrol

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 20 participants
• Primary outcome timeframe: up to 10 days of detoxification and induction
• Results posted on: 2021-12-09

Participant Flow

Participant milestones

Measure	Lofexidine Lofexidine prescribed as three 0.18mg tablets taken orally 4 times daily at 4-to 6-hour intervals for 2-10 days for the management of opioid withdrawal symptoms prior to receiving Vivitrol. Lofexidine 0.18 MG: Lofexidine prescribed as three 0.18mg tablets taken orally 4 times daily at 4-to 6-hour intervals for 2-10 days for the management of opioid withdrawal symptoms prior to receiving Vivitrol.
Overall Study STARTED	20
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment

Baseline characteristics by cohort

Measure	Lofexidine n=20 Participants Lofexidine prescribed as three 0.18mg tablets taken orally 4 times daily at 4-to 6-hour intervals for 2-10 days for the management of opioid withdrawal symptoms prior to receiving Vivitrol. Lofexidine 0.18 MG: Lofexidine prescribed as three 0.18mg tablets taken orally 4 times daily at 4-to 6-hour intervals for 2-10 days for the management of opioid withdrawal symptoms prior to receiving Vivitrol.
Age, Continuous	40.9 years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 10 days of detoxification and induction

Population: number of individuals who enrolled in the trial and initiated the detoxification/induction process

number of participants inducted onto Vivitrol

Outcome measures

Measure

Lofexidine n=20 Participants Lofexidine prescribed as three 0.18mg tablets taken orally 4 times daily at 4-to 6-hour intervals for 2-10 days for the management of opioid withdrawal symptoms prior to receiving Vivitrol. Lofexidine 0.18 MG: Lofexidine prescribed as three 0.18mg tablets taken orally 4 times daily at 4-to 6-hour intervals for 2-10 days for the management of opioid withdrawal symptoms prior to receiving Vivitrol.

Successful Vivitrol Induction

10 Participants

Adverse Events

Lofexidine

Serious events: 2 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lofexidine n=20 participants at risk Lofexidine prescribed as three 0.18mg tablets taken orally 4 times daily at 4-to 6-hour intervals for 2-10 days for the management of opioid withdrawal symptoms prior to receiving Vivitrol. Lofexidine 0.18 MG: Lofexidine prescribed as three 0.18mg tablets taken orally 4 times daily at 4-to 6-hour intervals for 2-10 days for the management of opioid withdrawal symptoms prior to receiving Vivitrol.
General disorders inpatient detoxification	5.0% 1/20 • Number of events 1 • 2-10 day induction period followed by 8 weeks of the trial
Cardiac disorders myocardial infarction	5.0% 1/20 • Number of events 1 • 2-10 day induction period followed by 8 weeks of the trial

Other adverse events

Measure	Lofexidine n=20 participants at risk Lofexidine prescribed as three 0.18mg tablets taken orally 4 times daily at 4-to 6-hour intervals for 2-10 days for the management of opioid withdrawal symptoms prior to receiving Vivitrol. Lofexidine 0.18 MG: Lofexidine prescribed as three 0.18mg tablets taken orally 4 times daily at 4-to 6-hour intervals for 2-10 days for the management of opioid withdrawal symptoms prior to receiving Vivitrol.
General disorders dizziness	60.0% 12/20 • Number of events 12 • 2-10 day induction period followed by 8 weeks of the trial
Gastrointestinal disorders diarrhea	20.0% 4/20 • Number of events 4 • 2-10 day induction period followed by 8 weeks of the trial
General disorders insomnia	20.0% 4/20 • Number of events 4 • 2-10 day induction period followed by 8 weeks of the trial
Psychiatric disorders anxiety	10.0% 2/20 • Number of events 2 • 2-10 day induction period followed by 8 weeks of the trial
Psychiatric disorders depression	10.0% 2/20 • Number of events 2 • 2-10 day induction period followed by 8 weeks of the trial
General disorders fatigue	10.0% 2/20 • Number of events 2 • 2-10 day induction period followed by 8 weeks of the trial
Gastrointestinal disorders GI upset	10.0% 2/20 • Number of events 2 • 2-10 day induction period followed by 8 weeks of the trial
General disorders headache	10.0% 2/20 • Number of events 2 • 2-10 day induction period followed by 8 weeks of the trial
Cardiac disorders orthostasis	10.0% 2/20 • Number of events 2 • 2-10 day induction period followed by 8 weeks of the trial
Gastrointestinal disorders vomiting	10.0% 2/20 • Number of events 2 • 2-10 day induction period followed by 8 weeks of the trial
General disorders anhedonia	5.0% 1/20 • Number of events 1 • 2-10 day induction period followed by 8 weeks of the trial
Eye disorders blurred vision	5.0% 1/20 • Number of events 1 • 2-10 day induction period followed by 8 weeks of the trial
General disorders drowsiness	5.0% 1/20 • Number of events 1 • 2-10 day induction period followed by 8 weeks of the trial
Gastrointestinal disorders hyporexia	5.0% 1/20 • Number of events 1 • 2-10 day induction period followed by 8 weeks of the trial
Cardiac disorders hypotension	5.0% 1/20 • Number of events 1 • 2-10 day induction period followed by 8 weeks of the trial
Musculoskeletal and connective tissue disorders muscle aches	5.0% 1/20 • Number of events 1 • 2-10 day induction period followed by 8 weeks of the trial
Cardiac disorders myocardial infarction	5.0% 1/20 • Number of events 1 • 2-10 day induction period followed by 8 weeks of the trial
Gastrointestinal disorders nausea	5.0% 1/20 • Number of events 1 • 2-10 day induction period followed by 8 weeks of the trial
General disorders weight loss	5.0% 1/20 • Number of events 1 • 2-10 day induction period followed by 8 weeks of the trial

Additional Information

Frances R Levin, MD

New York State Psychiatric Institute

Phone: 6467746137

Email: frances.levin@nyspi.columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place